LASIK, or laser-assisted in situkeratomileusis, is a type of refractive surgery designed to correct common vision impairments such as myopia (nearsightedness), hyperopia (farsightedness), and astigmatism by permanently reshaping the cornea, the clear front surface of the eye, to improve focusing power and reduce or eliminate the need for glasses or contact lenses.[1][2] This outpatient procedure, which typically takes less than 30 minutes for both eyes, uses a precise excimer laser to remove microscopic layers of corneal tissue, altering its curvature without the need for stitches.[1] It is one of the most commonly performed elective vision correction surgeries worldwide, with over 40 million procedures conducted as of 2025 and patient satisfaction rates of 95-99%.[3][4]LASIK involves creating a thin corneal flap, which is lifted to allow laser reshaping of the underlying tissue before being repositioned to heal naturally, enabling rapid visual recovery.[1][2] Developed in the late 1980s and approved for clinical use in the 1990s, it has evolved with advancements like femtosecond lasers for improved precision.[2]It is suitable for adults with stable refractive errors and healthy eyes, though not all candidates qualify due to factors like corneal thickness or certain medical conditions.[1][2] Over 90% of patients achieve 20/20 vision or better as of 2025, but potential side effects include temporary dry eyes and visual disturbances, with rare serious complications.[4][1][2]
Overview
Definition and Mechanism
Laser-Assisted In Situ Keratomileusis (LASIK) is a refractive surgery procedure that uses an excimer laser to reshape the cornea, correcting common vision impairments such as myopia (nearsightedness), hyperopia (farsightedness), and astigmatism.[2][5] The excimer laser emits ultraviolet light at a wavelength of 193 nanometers, which precisely ablates corneal tissue without generating heat, allowing for controlled removal of microscopic layers to alter the cornea's curvature.[6] This technique combines the principles of keratomileusis, an older method of corneal reshaping, with modern laser technology to achieve accurate refractive correction.[6]The cornea, the clear front surface of the eye, plays a critical role in focusing incoming light onto the retina to form clear images.[5] Refractive errors occur when there is a mismatch between the eye's optical components—the cornea and lens—and the length of the eyeball, causing light to focus incorrectly: in myopia, light converges before the retina; in hyperopia, it focuses behind; and in astigmatism, the cornea's irregular shape distorts focus.[2] LASIK addresses these by modifying the corneal shape to redirect light properly, typically flattening the central cornea for myopia or steepening it for hyperopia.[5]In the LASIK mechanism, a thin corneal flap is created and lifted to expose the underlying stromal layer, where the excimer laserablates tissue to the desired depth, after which the flap is repositioned to heal naturally without stitches.[2] The ablation depth is calculated based on the degree of refractive error; for example, correcting 1 diopter of myopia generally requires removing approximately 12-14 micrometers of corneal tissue, depending on the laser system and optical zone size.[7] This precise tissue removal alters the cornea's refractive power, enabling most patients to achieve 20/20 vision or better without glasses or contacts.[2]Since its introduction, LASIK has become one of the most widely performed elective surgeries globally, with more than 40 million procedures performed worldwide as of 2020.[3]
Indications and Candidacy
LASIK is primarily indicated for the correction of refractive errors in patients with myopia typically between -0.5 and -9.00 diopters (up to -12.00 diopters), hyperopia up to +4.00 diopters (up to +6.00 diopters), and astigmatism up to 5.00 diopters (up to 6.00 diopters), provided the prescription has remained stable for at least one year.[8][9][2] These ranges align with FDA-approved parameters for excimer laser treatment, ensuring predictable reshaping of the cornea to improve uncorrected visual acuity, though exact limits vary by laser system and patient factors.Ideal candidates are typically adults aged 18 to 40 years with ocular maturity and stable refraction, though individuals older than 40 may qualify if their prescription shows no significant change over time.[10] They must have healthy corneas with a minimum central thickness of 500 micrometers to accommodate flap creation and ablation while preserving adequate residual stromal bed depth.[11][12] Systemic health is crucial, with exclusion of conditions that impair wound healing, such as uncontrolled diabetes or immunosuppression.[13]Candidacy assessment involves key screening factors, including corneal topography to evaluate surface regularity, pachymetry to measure thickness, and pupil size measurement to assess night vision risks.[14] Patients at risk for ectasia—such as those with thin corneas or suspicious topography—are excluded using advanced imaging like Pentacam tomography, which provides detailed anterior and posterior corneal elevation maps for early detection of abnormalities.[15][16]LASIK is contraindicated in cases of pregnancy, autoimmune disorders like rheumatoid arthritis, and severe dry eye disease, as these can lead to unstable refraction or poor healing outcomes.[17][1][13] For presbyopia, monovision LASIK—correcting one eye for distance and the other for near vision—may be considered as a secondary option in select patients over 40, but it is not a primary indication and requires preoperative adaptation testing.[18]
Surgical Procedure
Preoperative Evaluation
The preoperative evaluation for LASIK surgery is a comprehensive assessment designed to confirm patient suitability, identify potential risks, and optimize outcomes by ensuring corneal stability and overall ocular health. This process typically occurs after patients discontinue contact lens wear to allow accurate measurements, with soft lenses ceased at least one week prior and rigid gas permeable lenses three to four weeks prior.[19][2] The evaluation includes a detailed medical and ocular history to screen for contraindications such as autoimmune diseases, uncontrolled diabetes, or prior ocular infections, alongside a physical examination focusing on uncorrected and corrected visual acuity through manifest and cycloplegic refraction.[19][2]A thorough eye examination forms the core of the preoperative process, encompassing slit-lamp biomicroscopy to inspect the eyelids, conjunctiva, cornea, anterior chamber, and lens for abnormalities like blepharitis or cataracts; a dilated fundus examination to evaluate the retina and optic nerve; and tonometry to measure intraocular pressure.[19][20] Tear film assessment is essential to detect dry eye syndrome, using tests such as tear breakup time and Schirmer's test, with any identified deficiencies treated—via artificial tears, punctal plugs, or medications like cyclosporine—prior to proceeding, as dry eye can exacerbate postoperative complications.[19][2] Additionally, contrast sensitivity testing may be performed to gauge functional vision quality.[19]Corneal analysis is critical for detecting irregularities that could lead to complications like ectasia, involving corneal topography or tomography to map the anterior and posterior surfaces using devices like Scheimpflug cameras, which help screen for conditions such as keratoconus.[19][2] Pachymetry measures central corneal thickness, typically around 550 microns in healthy eyes, to ensure sufficient tissue for flap creation and ablation.[2] Aberrometry and wavefront analysis identify higher-order aberrations, guiding customized treatment plans, while pupil size is measured under scotopic conditions with an infrared pupillometer to determine the optimal ablation zone and mitigate risks of nighttime visual disturbances like halos or glare in patients with larger pupils.[19][20]Patient education is integral to the evaluation, involving informed consent discussions that outline realistic expectations, such as potential need for reading glasses post-surgery, lifestyle impacts, and brief overviews of risks including dry eyes, infection, or under/over-correction.[21][19] Alternatives to LASIK, such as continued contact lens use or other refractive procedures like PRK, are reviewed to ensure the patient understands options and commits to follow-up care.[2][21] The full evaluation is generally scheduled one to two weeks before surgery, allowing time for any necessary interventions and confirmation of stable refraction.[21][20]
Intraoperative Steps
The LASIK intraoperative procedure is performed in a sterile operating environment to minimize infection risk, typically as an outpatient surgery under bilateral sequential protocol, where both eyes are treated in the same session but one after the other.[20][22] The process begins with the application of topical anesthetic eye drops to numb the surface of the eye, eliminating the need for injections or general anesthesia; the patient is instructed to fixate on a target light to maintain steady gaze throughout the procedure.[23][24] An eyelid speculum is inserted to prevent blinking, and a suction ring is applied to stabilize the eye, temporarily raising intraocular pressure to facilitate tissue separation—often verified to exceed 65 mm Hg using a pneumotonometer.[6]Next, a corneal flap is created using either a mechanical microkeratome, which employs a oscillating blade guided by the suctionring, or a femtosecond laser, which delivers infrared pulses to form a precise separation plane through photodisruption. The flap is typically 100-180 μm thick, with a diameter of 8-9 mm, and includes a hinge positioned superiorly at the 12 o'clock meridian to allow folding and subsequent repositioning.00768-3/fulltext)[25] Once created, the flap is gently lifted to expose the underlying stromal bed, and the exposed surface is dried to ensure optimal laser interaction.[23]The excimer laser, operating at a 193 nm ultraviolet wavelength, is then used to ablate and reshape the exposed stroma according to preoperative measurements, removing precise amounts of tissue to correct refractive errors. An integrated eye-tracking system compensates for involuntary movements by monitoring pupil position up to 500 times per second and pausing the laser if fixation deviates excessively, ensuring accuracy. The ablation phase lasts 20-50 seconds per eye, during which patients may hear a clicking sound and notice a brief odor of burning tissue.[26][24]Following ablation, the corneal flap is irrigated with a balanced salt solution to remove debris, then carefully repositioned over the treated bed without the need for sutures, as it adheres naturally through bioadhesion. The interface is smoothed with a spatula to promote even healing, and intraocular pressure is checked post-repositioning to confirm normalization. The entire procedure per eye typically takes 10-15 minutes, allowing for efficient bilateral treatment.[23][24][6]
Postoperative Management
Immediately following LASIK surgery, patients are typically prescribed topical antibiotic and steroideye drops to prevent infection and reduce inflammation, administered for 4 to 10 days. A protective eye shield is placed over the operated eye to prevent accidental rubbing or injury during the initial healing phase, and patients are advised to rest with their eyes closed for several hours as vision remains blurry and discomfort such as itching or a gritty sensation may occur. The corneal flap created during the procedure is repositioned and requires avoidance of eye rubbing to ensure proper adherence.[27][23][1]Follow-up appointments are scheduled to monitor healing, typically beginning within 24 to 48 hours postoperatively, followed by visits at one week, one month, and then at 3, 6, and 12 months to assess flap position, refractive stability, and overall recovery. These evaluations help confirm that the corneal flap is healing correctly and that vision is improving as expected.[23][1][28]Symptom management includes the use of preservative-free artificial tears to address temporary dryness and discomfort, as well as wearing sunglasses to mitigate light sensitivity and glare. Patients are instructed to avoid activities such as swimming, using hot tubs, or engaging in contact sports for at least 1 to 2 weeks, and to refrain from eye makeup or lotions for up to 2 weeks to minimize infection risk. Driving is generally permitted the day after surgery if vision meets legal standards, though some may need 1 to 2 days.[23][1][27]Recovery typically allows a return to work or normal activities within 1 to 3 days for most patients, with many achieving 20/40 vision or better by the next day, though fluctuations may occur. Full visual stabilization generally takes 3 to 6 months, during which patients should report any persistent symptoms.[28][23][1]Early complications monitoring focuses on signs such as severe pain, sudden vision loss, increased redness, or discharge, which may indicate infection or flap displacement, prompting immediate contact with the surgeon. Routine follow-ups enable early detection and intervention for such issues.[23][1][27]
Variations and Advanced Techniques
Wavefront-guided LASIK employs an aberrometer to create a detailed map of the eye's optical aberrations, including higher-order aberrations that cause visual disturbances such as halos and glare. This technology enables custom ablation patterns tailored to the patient's unique optical profile, potentially improving contrast sensitivity and night vision by correcting both lower- and higher-order aberrations. Clinical evidence indicates that wavefront-guided procedures reduce postoperative halos and glare in a significant proportion of patients, with enhancements showing elimination or reduction in these symptoms at six months post-surgery.[29][30][31][32]Topography-guided LASIK focuses on corneal surface irregularities, making it suitable for treating abnormal corneas, such as those affected by trauma or prior surgery. The Contoura Vision system, approved by the FDA in 2016 for correcting myopia with or without astigmatism, uses advanced corneal topography to generate personalized treatment plans based on thousands of elevation points per eye. This approach enhances outcomes in irregular corneas by smoothing subtle surface variations, often providing superior visual quality compared to standard methods for patients ineligible for conventional LASIK.[33][34][35][36]The evolution of femtosecond lasers has enabled all-laser LASIK, with the IntraLase system receiving FDA approval in 2001 for creating precise corneal flaps. This method uses ultrafast laser pulses to form the flap, offering greater accuracy and customization than mechanical microkeratomes, which reduces risks like flap irregularities or incomplete cuts. Femtosecond-assisted procedures demonstrate lower complication rates, including fewer instances of opaque bubble layer or interface issues, while maintaining high safety profiles in flap creation.[37][38][39][40]Blended vision, also known as monovision LASIK, addresses presbyopia by correcting one eye for distance vision and the other for near vision, allowing the brain to integrate the images for improved functional vision across ranges. This technique is particularly beneficial for patients over 40 experiencing age-related near vision loss, reducing reliance on reading glasses without altering the overall LASIK process. Success depends on patient adaptation, with many achieving glasses-free vision for daily activities after the brain adjusts to the monocular inputs.[41][42][43][44]Recent advancements from 2024 to 2025 incorporate AI for real-time surgical adjustments, analyzing eye movements and optimizing laser parameters during procedures to enhance precision and outcomes. Ray-tracing guided LASIK, which simulates light paths through the eye for customized ablation, outperformed SMILE Pro in a 2025 American Academy of Ophthalmology study, achieving 20/12.5 vision or better in 98% of cases compared to 82%. Customized corneal mapping has also advanced presbyopia treatments, using three-dimensional topography to tailor ablations for multifocal-like effects, expanding LASIK's applicability to complex refractive needs.[45][46][47][48][49][50]
Historical Development
Early Innovations in Refractive Surgery
The foundations of refractive surgery were laid in the mid-20th century through mechanical techniques aimed at reshaping the cornea to correct refractive errors, primarily myopia, without the use of lasers. In 1948, Spanish ophthalmologist José Ignacio Barraquer, working in Bogotá, Colombia, pioneered keratomileusis, a procedure that involved extracting a corneal layer, freezing it, and using a lathe to sculpt its curvature before reimplanting it to alter the eye's refractive power.[51] This innovation marked the first systematic approach to stromal sculpting, enabling corrections for high degrees of ametropia while preserving the cornea's structural integrity, though it required microsurgical precision and carried risks of tissue irregularity.[52] Barraquer's work at the Instituto Barraquer established refractive surgery as a viable field, influencing subsequent mechanical methods by demonstrating that controlled corneal modification could achieve predictable optical outcomes.[53]Building on these principles, radial keratotomy (RK) emerged in the 1970s as a simpler, incision-based technique for low-to-moderate myopia. In 1974, Soviet ophthalmologist Svyatoslav Fyodorov developed RK, which entailed making deep radial incisions in the peripheral cornea to flatten its central curvature and reduce nearsightedness, inspired by observations of accidental cuts healing with refractive improvement.[54] Fyodorov's method gained traction in the USSR, where he performed thousands of procedures, reporting stabilization of refractive error in many patients within months, though long-term predictability varied due to wound healing responses.[55] By 1978, RK was introduced in the United States by surgeons like Leo Bores, who trained under Fyodorov, sparking clinical trials that confirmed its efficacy for myopia up to -4 diopters but highlighted issues like diurnal fluctuations in vision.[56] This procedure's widespread adoption underscored the potential of non-extraction techniques, yet its reliance on manual incisions limited precision and reproducibility.[57]The 1980s saw precursors to more refined corneal ablation methods, bridging mechanical innovations toward laser integration. Early experiments with the excimer laser, developed at IBM's T.J. Watson Research Center in the 1960s for material processing, demonstrated precise ultraviolet ablation of organic tissues without thermal damage, laying groundwork for photorefractive keratectomy (PRK).[58] In 1983, ophthalmologist Stephen Trokel conducted the first human application of excimer laser ablation on the cornea, etching superficial layers to correct refractive errors in a controlled manner and validating its potential for smooth stromal reshaping.[59] These foundational efforts were advanced by researchers like Peter J. McDonnell, whose early studies on corneal biomechanics and sculpting techniques explored tissue responses to ablation, informing safer protocols for refractive correction.[60] McDonnell's collaborative work emphasized the importance of preserving corneal strength during reshaping, setting critical parameters for future procedures.[61]
Emergence of Laser-Based Methods
The emergence of laser-based methods in refractive surgery marked a pivotal shift toward precise, non-mechanical corneal reshaping, building briefly on foundational techniques like Jose Barraquer's keratomileusis from the mid-20th century. In 1989, Gholam A. Peyman received U.S. Patent No. 4,840,175 for a method to modify corneal curvature using an excimer laser to ablate tissue in a controlled manner, laying the groundwork for photorefractive procedures.[62] This innovation addressed limitations of earlier manual methods by enabling ultraviolet laser pulses to vaporize corneal tissue without thermal damage, targeting refractive errors like myopia.00336-3/fulltext)The first LASIK procedure, integrating a corneal flap with excimer laserablation, was performed in 1990 by Ioannis Pallikaris at the University of Crete in Greece.[63] Pallikaris combined the keratomileusis flap technique—created using a microkeratome—with excimer laserphotorefractive keratectomy (PRK) on the exposed stromal bed, allowing for in situ reshaping while preserving epithelial integrity for potentially faster healing.[53] This hybrid approach, termed laser-assisted in situkeratomileusis (LASIK), demonstrated promising visual outcomes in early human applications, surpassing surface ablation alone.[63]In the United States, the first LASIK procedures occurred in 1991 during FDA clinical trials, led by Stephen Slade and Stephen Brint in Houston, Texas.[64] These trials built on prior PRK research, including Marguerite McDonald's pioneering excimer laser work in 1988, but introduced the flap to minimize postoperative discomfort.[65] The excimer laser received FDA approval for PRK in 1995, initially for myopia correction up to -7 diopters using systems like the VISX Excimer Laser.[66]Throughout the 1990s, clinical trials facilitated the transition from PRK to LASIK, driven by LASIK's advantages in recovery time—patients often achieved functional vision within hours compared to weeks for PRK—while reducing risks like haze formation.[37] By the late 1990s, adoption surged, with over 1 million LASIK procedures performed annually in the U.S. by 2000, reflecting widespread surgeon training and technological refinements.[67]
Commercialization and Regulation
The commercialization of LASIK began in the mid-1990s, driven by key patents and industry developments centered on excimer laser technology. Summit Technology, Inc., played a pivotal role with its early excimer lasers, securing initial FDA approvals for photorefractive keratectomy (PRK) in 1995 and advancing toward LASIK applications through innovations like the Apex laser system.[68] These efforts built on the foundational procedure introduced by Ioannis Pallikaris in 1990, enabling rapid industry scaling.[69] Globally, LASIK saw early adoption in Europe starting in 1989, with widespread clinical use by the mid-1990s, followed by expansion into Asia where clinics began offering the procedure in countries like Japan and South Korea during the late 1990s.[70][71]In the United States, regulatory milestones accelerated market entry. The Food and Drug Administration (FDA) granted the first approval for LASIK on October 21, 1999, to Summit Technology's SVS Apex Plus Excimer Laser Workstation for correcting myopia up to -14 diopters, with or without astigmatism up to -5 diopters.[72] This was followed by approvals for additional indications, including hyperopia and astigmatism, with systems like the Bausch & Lomb TECHNOLAS 217A receiving clearance for these corrections via LASIK in May 2002.[73] These approvals marked a shift from off-label use to standardized clinical practice, spurring investment in lasermanufacturing and surgical centers.Post-approval, LASIK experienced explosive growth in the US, reaching a peak of approximately 1.4 million procedures annually by the mid-2000s.[74] However, this boom was accompanied by aggressive marketing and pricecompetition among clinics, which fueled a surge in patient volume but also raised concerns about informed consent and outcomes.[75] By the early 2000s, lawsuits from patients alleging inadequate screening, exaggerated benefits, or complications like persistent dry eyes proliferated, with reports of over 140 serious adverse event complaints to the FDA between 1998 and 2006.[76] These issues culminated in a 2008 FDA advisory panel review, prompted by public petitions, to assess patient satisfaction and safety protocols.[77]
Modern Advancements
In the 2010s, femtosecond laser technology became widely adopted for creating corneal flaps in LASIK procedures, replacing traditional mechanical microkeratomes with greater precision and reduced complications.[78] Devices such as the IntraLase femtosecond laser enabled bladeless LASIK, revolutionizing the surgery by allowing for customizable flap dimensions and minimizing risks like epithelial ingrowth.[79] This shift contributed to improved safety profiles and broader clinical acceptance among ophthalmic surgeons.[80]Advancements in customization accelerated with the FDA approval of wavefront-guided and topography-guided treatments, notably Contoura Vision in early 2016, which uses detailed corneal mapping to address higher-order aberrations beyond standard prescriptions.[81] This approval marked a significant step in personalized refractive surgery, enabling outcomes that often exceeded 20/20 uncorrected visual acuity in clinical trials.[33]From 2020 to 2023, artificial intelligence emerged as a key tool for predictive modeling in LASIK, analyzing patient data to forecast surgical outcomes and identify ideal candidates with over 93% accuracy.[82]AI algorithms enhanced preoperative screening by predicting individual responses to laser treatment, optimizing treatment plans and reducing the risk of suboptimal results.[83] Concurrently, faster excimer lasers reduced ablation times to under 10 seconds per eye, improving patient comfort and procedural efficiency while maintaining high precision.[84]Recent innovations in 2024 and 2025 have further refined LASIK through ray-tracing guided procedures, which model light paths through the entire eye for highly accurate corrections. A 2025 study presented at the American Academy of Ophthalmology annual meeting demonstrated that ray-tracing guided LASIK achieved superior uncorrected visual acuity compared to SMILE Pro, with 98% of patients reaching 20/12.5 or better versus 82%.[48] The WaveLight EX500 excimer laser platform received FDA approval in March 2025, incorporating advanced femtosecond integration for wavefront-optimized treatments that enhance customization and speed.[85] Similarly, EagleVision LASIK, utilizing iDesign technology, provides enhanced personalization by measuring nearly 1,200 data points per eye to tailor ablations for individual optical profiles.[86]By 2025, these advancements have driven substantial growth in LASIK adoption, with approximately 800,000 procedures performed annually in the United States.[87] Globally, the cumulative total exceeds 40 million procedures since the technique's introduction, reflecting its established role in refractive surgery.[87]
Clinical Effectiveness
Success Rates and Outcomes
LASIK demonstrates high efficacy in correcting refractive errors, with modern meta-analyses reporting that approximately 91% of patients achieve uncorrected visual acuity of 20/20 or better, while 99.5% attain 20/40 or better, particularly in cases of myopia. These outcomes are derived from large-scale evaluations involving over 56,000 eyes, highlighting the procedure's predictability across a broad patient population.[3]Long-term stability remains a key strength of LASIK, with systematic reviews indicating that approximately 73% of eyes remain within ±1.00 D of the target refraction at 10 years post-surgery, with 92% within ±2.00 D, though regression is more common in higher myopia.[88] This durability is supported by retrospective studies showing minimal changes in refraction beyond the initial stabilization period, typically within the first three months.[89]Measurable outcomes further underscore LASIK's precision, as about 91% of patients achieve a reduction in refractive error to within 0.5 diopters of the intended target.[90] In wavefront-guided variants, this precision is complemented by enhancements in contrast sensitivity, reducing higher-order aberrations and improving low-light visual performance compared to conventional methods.[91]Recent 2025 advancements in ray-tracing-guided LASIK, as reported by the American Academy of Ophthalmology, have elevated outcomes, with 98% of treated eyes achieving 20/12.5 or better uncorrected visual acuity, surpassing traditional benchmarks.[48]
Patient Satisfaction
Patient satisfaction with LASIK surgery is notably high, with multiple studies reporting that 95% to 98% of patients would undergo the procedure again or express overall satisfaction with their outcomes. The FDA's Patient-Reported Outcomes With LASIK (PROWL) studies, which evaluated quality of life and visual symptoms, found satisfaction rates of 97% to 98% three months post-surgery, alongside significant improvements in daily activities such as driving at night and reading small print.[92][93]Key factors contributing to this satisfaction include the procedure's quick recovery time, often allowing improved vision within 24 hours, and the resulting independence from glasses or contact lenses, which enhances quality of life in professional and recreational pursuits. Customized LASIK procedures, which address individual higher-order aberrations, demonstrate higher satisfaction compared to standard LASIK, with wavefront-guided treatments linked to better visual quality and patient-reported outcomes in the 96% range versus approximately 92% for conventional methods.[94][95]Surveys from the American Academy of Ophthalmology (AAO) highlight particularly elevated satisfaction rates of up to 99% among patients with low to moderate myopia, where refractive predictability is greater. Long-term follow-up studies, extending 10 years or more, report sustained satisfaction around 92%, with stability in low to moderate corrections and minimal regression.[96][97]Influencing factors such as comprehensive preoperative education to set realistic expectations further boost satisfaction by aligning patient perceptions with achievable results. In contrast, satisfaction is somewhat lower for high prescriptions, where outcomes may involve slightly more variability in refractive accuracy and potential for residual errors.[98][99]
Limitations and Enhancements
One key limitation of LASIK is its inability to correct presbyopia, the progressive loss of near vision due to lens stiffening that typically begins after age 40, as the procedure primarily reshapes the cornea to address distance vision errors like myopia, hyperopia, and astigmatism.[100] While LASIK can improve uncorrected distance visual acuity, patients over 40 often require reading glasses postoperatively for near tasks unless monovision is employed, where the dominant eye is corrected for distance and the nondominant for near vision.[2] Monovision LASIK has demonstrated effectiveness in 72% to 92% of suitable presbyopic patients, enabling spectacle independence for many daily activities, though adaptation may take weeks to months.[101] However, this approach compromises binocular stereoacuity, with studies reporting reduced depth perception in 20% to 40% of cases due to interocular rivalry and altered fusion, potentially affecting tasks like driving at night or sports.[102] Qualitative assessments confirm high overall satisfaction (over 85% in selected cohorts) but highlight persistent challenges with stereopsis for some individuals.[103]Enhancements, or retreatments, are sometimes necessary following initial LASIK to address refractive regression, where corneal healing leads to a gradual shift in vision correction over time. Clinical studies indicate that 10% to 15% of patients require enhancement within 10 years, particularly those with higher preoperative myopia, though rates vary by technology and patient factors.[104] These procedures are generally safe when residual corneal thickness exceeds 250 to 300 micrometers post-enhancement, minimizing risks to structural integrity, and often involve lifting the original flap for additional laser ablation.[6] Long-term follow-up data show that enhancements maintain efficacy indices above 0.9 (achieving 20/40 or better uncorrected vision) without significantly increasing complication rates compared to primary surgery.[105]LASIK has inherent limitations for certain refractive errors and corneal conditions, restricting its applicability. It is not recommended for high hyperopia exceeding +6 diopters, as FDA-approved platforms limit treatment to +6.00 D to avoid excessive ablation and regression, with higher degrees risking undercorrection and induced aberrations.[8]Keratoconus, characterized by progressive corneal thinning and steepening, represents an absolute contraindication due to the heightened risk of postoperative ectasia, a rare but serious weakening of the cornea.[2] Over-ablation during LASIK, often from inadequate preoperative pachymetry assessment, further elevates ectasia risk by leaving insufficient stromal bed thickness (ideally >300 micrometers), with incidence rates under 0.5% in screened populations but higher in borderline cases.[106]Recent advancements in artificial intelligence diagnostics have addressed some enhancement needs by improving preoperative screening and treatment planning. As of 2025, AI-driven tools analyzing corneal tomography and multimodal data have improved ectasia risk prediction and regression forecasting.[107] These systems enable more precise nomograms and patient selection for optimal long-term stability.
Risks and Safety
Common Adverse Effects
One of the most frequent side effects following LASIK surgery is dry eye syndrome, resulting from the disruption of corneal nerves during flap creation, which temporarily impairs tear production and ocular surface stability.[2] Incidence rates indicate that 20-40% of patients experience noticeable dry eye symptoms in the initial postoperative period, though up to 95% report some degree of dryness immediately after surgery.[108] These symptoms typically peak within the first month and resolve for most patients within 6 months as nerves regenerate, managed effectively with preservative-free artificial tears and lubricants as part of standard postoperative care.[109] Recent 2025 analyses report that chronic dry eye persisting beyond 6 months affects approximately 5-10% of cases, often linked to preoperative risk factors like low tear breakup time, though some studies indicate higher rates up to 40% in long-term follow-up.[110][111]Visual disturbances, such as halos and glare around lights particularly in low-light conditions, are another common transient effect, attributed to irregularities in the corneal surface and pupil size relative to the treatment zone.[2] Up to 40-46% of patients report new visual symptoms including halos and glare at 3 months post-operation, according to patient-reported outcomes from the PROWL studies.[92] In approximately 90% of affected individuals, halos and glare diminish significantly within 3-6 months as the cornea stabilizes, though they may initially impact night driving. Severe cases rarely lead to significant quality-of-life issues, with less than 1% reporting substantial difficulty in daily activities.[109][92]Fluctuating vision, characterized by variable clarity during the early recovery phase, is also prevalent due to epithelial remodeling and temporary inflammation at the flap interface.[2] This effect is most common in the first week postoperatively and generally resolves without intervention as healing progresses.[109]Long-term data from prospective cohorts show that persistent common adverse effects beyond one year are rare, affecting less than 1% of patients overall.[112]
Rare Complications
While flap complications are infrequent in LASIK procedures, dislocation of the corneal flap occurs in approximately 0.1% of cases, often due to trauma or eye rubbing in the early postoperative period.[113] This can lead to visual distortion if not addressed promptly, with treatment typically involving immediate repositioning of the flap under topical anesthesia; persistent cases may require suturing or lubricants to promote adhesion.[113] Flap wrinkles, or striae, affect 1-2% of patients and result from uneven repositioning during surgery, manifesting as irregular astigmatism.[114] Management includes lifting and irrigating the flap for early intervention, while later occurrences may necessitate observation or additional surgical smoothing if symptomatic.Diffuse lamellar keratitis (DLK), a noninfectious inflammation within the flap interface, arises in about 0.5% of LASIK surgeries and is graded from mild (grade I) to severe (grade IV) based on density and extent.[115] It usually presents 1-6 days postoperatively and is treated effectively with topical steroids in most cases, resolving without long-term sequelae; severe instances may require flap lift and irrigation.[116] Prevention emphasizes sterile techniques and monitoring for outbreaks linked to environmental factors like povidone-iodine residue.[117]Corneal ectasia, a progressive thinning and bulging of the cornea, is a serious rare complication with an incidence of 0.04-0.6%, primarily stemming from preoperative corneal weakness not detected via standard screening.[118] It can cause irregular astigmatism and vision loss months to years post-surgery, managed with corneal cross-linking, rigid contact lenses, or transplantation in advanced cases.[119] Risk mitigation relies on advanced corneal topography and tomography during preoperative evaluation to identify subclinical abnormalities.[119]As of 2025, the adoption of femtosecond lasers for flap creation has reduced flap-related risks to under 0.1%, with overall serious complication rates below 1% according to large-scale analyses.[120] This improvement stems from precise, customizable flap dimensions that minimize misalignment and ingrowth, enhancing safety profiles in modern LASIK protocols.[1]
Contraindications
Contraindications for LASIK surgery are conditions or factors that make the procedure unsafe or likely to result in poor outcomes, categorized as absolute (prohibiting surgery entirely) or relative (requiring careful evaluation and often precluding it). Thorough preoperative screening is essential to identify these, as they can lead to complications such as ectasia, infection, or suboptimal vision correction. Guidelines from authoritative bodies like the American Academy of Ophthalmology and the FDA emphasize excluding patients with these risks to ensure safety.[121][13]Absolute contraindications include insufficient corneal thickness, typically less than 500 micrometers preoperatively, which risks postoperative ectasia due to inadequate residual stromal bed (minimum 250 micrometers).[2][27] Active autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, or Sjögren's syndrome, are also absolute due to impaired wound healing and increased infection risk.[2][122] Uncontrolled keratoconus or corneal ectasia, including subclinical forms, prohibits LASIK as it destabilizes the cornea and heightens ectasia risk.[2][121]Relative contraindications encompass high-risk occupations involving contact sports or trauma, such as military service, where flap complications could occur.[123]Pregnancy or breastfeeding is a relative contraindication due to hormonal vision fluctuations and potential medication risks, with recommendations to delay surgery until at least three months postpartum.[13] Unstable refraction, defined as changes greater than 0.5 diopters in the past year, and severe dry eye syndrome are relative, as they can affect accuracy and exacerbate postoperative dryness.[2][121]Systemic relative contraindications include diabetes with poor glycemic control or immunosuppression, which impair healing and increase infection susceptibility.[2][13] Ocular relative contraindications involve large pupils exceeding 8 mm in low light, raising risks of glare and halos, and amblyopia, which may limit visual improvement potential.[1][2]In 2025 guidelines, AI-assisted screening, including multimodal large language models, enhances detection of contraindications by analyzing corneal topography and patient data, improving identification accuracy over manual methods alone.[124][125]
Regulatory Oversight
The U.S. Food and Drug Administration (FDA) regards LASIK as a safe and effective procedure for qualified candidates who meet specific eligibility criteria, including stable vision prescriptions and healthy corneas.[72] This stance is supported by rigorous premarket approval processes that evaluate clinical trial data on safety and efficacy outcomes.[126] In July 2022, the FDA issued draft guidance recommending standardized patient labeling for LASIK laser devices, mandating clear disclosures of common risks such as dry eyes, halos, glare, and potential long-term visual disturbances to enhance informed decision-making.[127] As of 2025, the FDA continues to emphasize robust informed consent processes, requiring surgeons to discuss these risks thoroughly with patients prior to surgery.[128]The FDA has approved more than 40 excimer and femtosecond laser systems for LASIK, enabling precise corneal reshaping for myopia, hyperopia, and astigmatism corrections.[72] Notable recent approvals include the WaveLight EX500 excimer laser system by Alcon Laboratories, Inc., on March 5, 2025, which supports wavefront-guided treatments for enhanced visual quality.[85] Post-market surveillance occurs via the Manufacturer and User Facility Device Experience (MAUDE) database, where healthcare providers and manufacturers report adverse events to monitor real-world performance and identify rare issues like flap complications or infections.[129]Internationally, LASIK technologies have held CE marking in the European Union since the mid-1990s, certifying compliance with stringent safety, health, and environmental protection standards for refractive procedures.[130] In 2025, the FDA reaffirmed that serious complications from LASIK occur in less than 1% of cases, well below the agency's 5% safety threshold, based on ongoing data from clinical studies and the PROWL (Patient-Reported Outcomes with LASIK) collaboration.[92] This low rate underscores LASIK's established profile as a standard refractive option, with regulatory focus remaining on patient selection and comprehensive risk communication.[112]
Comparisons to Alternatives
Photorefractive Keratectomy (PRK)
Photorefractive keratectomy (PRK) is a laser eye surgery technique that corrects refractive errors by performing surface ablation on the cornea without creating a flap. In the procedure, the surgeon first removes the thin outer layer of the cornea, known as the epithelium, using methods such as a blunt spatula, excimer laser, or chemical solution, exposing Bowman's layer and the underlying stroma. An excimer laser then precisely ablates the stromal tissue to reshape the cornea's curvature, improving focus on the retina for conditions like myopia, hyperopia, and astigmatism.[131][132]Compared to LASIK, PRK avoids the risks associated with corneal flap creation, such as displacement or complications from trauma, making it a safer option for patients in high-impact professions or those with thin corneas where flap creation might compromise structural integrity. Recovery from PRK is notably slower and more uncomfortable than LASIK; patients often experience moderate pain for 2-3 days, corneal haze for 3-7 days, and gradual improvement to functional vision over 1-3 months, whereas LASIK typically achieves clear vision within hours to days, representing approximately 80% faster visual recovery in early postoperative periods. A 2025 U.S. Army study of over 4,400 eyes found that only 56.5% of PRK patients achieved 20/20 or better uncorrected distance visual acuity at one month postoperatively, compared to 94.7% for LASIK, though stability improves significantly by three months. PRK is particularly suitable for individuals with thin corneas, as it preserves more stromal tissue and reduces the risk of postoperative ectasia to 0.020% (20 per 100,000 eyes), lower than the 0.090% (90 per 100,000 eyes) incidence reported for LASIK.[131][133][134]Long-term outcomes for PRK are comparable to those of LASIK, with approximately 95% of patients achieving 20/20 or better uncorrected vision at six months or later, demonstrating similar efficacy in refractive correction. However, PRK involves greater initial discomfort and a higher likelihood of temporary pain due to the epithelial removal and exposure of deeper layers. In 2025, PRK remains the preferred method for military personnel and athletes in high-risk environments, such as pilots or contact sport participants, due to its flapless design that minimizes vulnerability to injury, as evidenced by ongoing adoption in U.S. military refractive surgery protocols.[133][135][136]
Small Incision Lenticule Extraction (SMILE)
Small Incision Lenticule Extraction (SMILE) is a flapless laserrefractive surgery technique that uses a femtosecondlaser to create an intrastromal lenticule within the cornea, which is then removed through a small 2-4 mm incision to reshape the corneal curvature and correct refractive errors.[137][138] Unlike LASIK, which involves creating a corneal flap for excimer laserablation, SMILE eliminates the need for a flap, reducing the risk of flap-related complications such as displacement or epithelial ingrowth.[139] The procedure is typically completed in 10-15 minutes per eye and is primarily approved for treating myopia up to -10 diopters and astigmatism up to -3 diopters, but not hyperopia.[137][140]In comparison to LASIK, SMILE offers advantages in postoperative dry eye due to preservation of more corneal nerves, as the smaller incision disrupts fewer sub-basal nerve fibers; studies indicate a lower incidence of dry eye symptoms in SMILE, with rates around 20% in the early postoperative period versus up to 40% for LASIK.[141][142] However, recovery of visual acuity is generally slower with SMILE, taking 1-2 days for functional vision compared to hours with LASIK, owing to the manual lenticule extraction and absence of immediate flap repositioning.[143]SMILE's applicability is more limited, confined to myopia and astigmatism without options for hyperopia correction that LASIK provides through customizable ablation profiles.[144]Visual outcomes between SMILE and LASIK are largely equivalent, with both achieving uncorrected distance visual acuity of 20/20 or better in approximately 96% of cases at six months postoperatively.[145]SMILE demonstrates a lower risk of corneal ectasia, with an estimated incidence of 11 per 100,000 eyes compared to higher rates in LASIK (90 per 100,000 eyes), attributed to the intact anterior corneal lamellae and biomechanical stability.[146][147] Nonetheless, SMILE's fixed lenticule shape limits customization for higher-order aberrations or hyperopia, areas where LASIK excels with wavefront-guided treatments.[148]Recent 2025 data from the American Academy of Ophthalmology (AAO) annual meeting highlight advancements, showing that ray-tracing guided LASIK (Wavelight Plus) outperformed SMILE Pro in a head-to-head randomized study, with 92% of LASIK eyes achieving 20/20 or better uncorrected visual acuity versus 74% for SMILE Pro, and superior low-light performance.[48] Additionally, SMILE procedures typically cost 10-20% more than LASIK, ranging from $2,500-3,500 per eye for SMILE compared to $2,000-3,000 for LASIK, due to specialized femtosecondlaser requirements and limited surgeon availability.[149][150]
Future Directions
Ongoing Clinical Trials
Ongoing clinical trials in LASIK focus on enhancing precision, expanding applications, and mitigating risks through innovative ablation techniques and patient selection criteria. A Phase III trial evaluating the VIS Opti-K System for presbyopia correction (NCT06487897) assesses safety and efficacy by inducing temporary monovision to improve near vision.[151] This study addresses the growing demand for simultaneous distance and near vision correction in presbyopic patients, building on wavefront-optimized approaches to reduce halos and improve contrast sensitivity.In the realm of ablation optimization, studies sponsored by Alcon, presented at the 2025 American Academy of Ophthalmology (AAO) and European Society of Cataract and Refractive Surgeons (ESCRS) meetings, compare ray-tracing-guided LASIK (Wavelight Plus) against SMILE Pro and wavefront-optimized methods for myopia and myopic astigmatism. These prospective studies demonstrate superior visual outcomes, efficacy, and safety with ray-tracing-guided LASIK, including reduced higher-order aberrations.[152][48] This approach leverages computational modeling to personalize ablation as of October 2025.Efforts to prevent long-term complications like corneal ectasia are addressed in a 2025 study using AI-driven finite element analysis to model the biomechanical impacts of LASIK, PRK, and SMILE on ectasia susceptibility in healthy and keratoconic corneas. This computational analysis evaluates optomechanical effects to refine screening protocols for high-risk patients.[153]Ethical considerations in these trials emphasize rigorous Institutional Review Board (IRB) oversight to ensure equitable inclusion, particularly addressing corneal variations across diverse ethnicities. Protocols mandate representation of underrepresented groups to validate generalizability, with IRBs requiring DEI elements in studydesign to mitigate biases in outcomes for global populations.[154][155] Such measures align with guidelines promoting inclusive recruitment in refractive surgery research.
Emerging Technologies
Artificial intelligence and machine learning are transforming LASIK through applications in preoperative screening and detection of prior interventions. AI models trained on corneal imaging data, such as optical coherence tomography (OCT), can identify history of LASIK with high accuracy, aiding in candidate selection and complication risk assessment. By analyzing corneal topography and tomography, these tools support customized ablation patterns to minimize enhancements. A 2025 review highlights AI's role in enhancing precision in laser vision correction.[156][46]Femtosecond lasers, a cornerstone of modern LASIK, are advancing toward ultra-short pulse durations around 100 femtoseconds to achieve submicron precision in flap creation and lenticule extraction, minimizing thermal damage and cavitation bubbles while enhancing cut quality. This evolution builds on infrared lasers operating at 1053 nm wavelengths, enabling bladeless procedures with reduced opacity risks compared to longer-pulse systems.[78]Experimental techniques include the reuse of extracted lenticules from small incision lenticule extraction (SMILE, a LASIK variant) to address hyperopia, where cryopreserved stromal tissue is reimplanted into the cornea of another patient to add thickness and correct refractive errors. Studies demonstrate that allogeneic lenticules can safely increase corneal volume, with efficacy comparable to traditional hyperopic LASIK in primate models and early human applications, though optimization for spherical equivalence remains ongoing to treat up to +3.00 diopters. Preservation methods, such as glycerol or organ culture media, maintain lenticule viability for weeks, opening avenues for tissue banking and personalized corrections in presbyopia or keratoconus adjuncts. A 2025 narrative review summarizes progress in lenticule preservation and reuse.[157][158][159][160]Augmented reality (AR) integration provides real-time surgical guidance by overlaying 3D corneal models onto the operative field, allowing surgeons to track eye movement and adjust laser parameters dynamically during ablation. Prototype AR platforms, using head-mounted displays, fuse preoperative wavefront data with live video feeds to enhance precision in topography-guided treatments, reducing higher-order aberrations in simulated procedures.