Keratomileusis is a refractive surgery technique designed to correct vision impairments such as myopia, hyperopia, and astigmatism by precisely reshaping the cornea, the clear front surface of the eye.[1] The procedure involves creating and removing a thin corneal cap using a microkeratome, modifying the cap—originally through mechanical carving or freezing methods—and then repositioning it to alter the cornea's curvature and focus light properly onto the retina.[2] First conceptualized in the late 1940s, it marked a pioneering advancement in ophthalmology by introducing computer-assisted calculations for refractive adjustments, making it the foundational method for modern corneal surgeries.[3]The technique originated from the work of Spanish ophthalmologist José Ignacio Barraquer, who in 1949 described lamellar corneal surgery to address refractive errors while practicing in Bogotá, Colombia.[1] By the late 1950s, Barraquer refined the process with the development of a precise microkeratome and a cryolathe—a device that froze and lathe-carved the corneal disc for reshaping—allowing for the first successful in situ lamellar resections in 1958.[2] These early methods, often requiring the cornea to be excised and extracorporeally modified, laid the groundwork for non-freeze techniques in the 1980s, pioneered by figures like Jörg H. Krumeich, Casimir A. Swinger, and others who introduced automated systems such as the BKS 1000 for more accurate stromal sculpting without cryogenic elements.[3]Keratomileusis evolved significantly in the late 20th century, transitioning into laser-assisted variants that form the basis of contemporary procedures like LASIK (laser-assisted in situ keratomileusis).[4] In 1989, Lucio Buratto advanced photokeratomileusis by incorporating excimer laser ablation for tissue removal, while Ioannis G. Pallikaris's 1990 innovation of a hinged corneal flap enabled in situ laser treatment, drastically improving safety, recovery time, and predictability.[2] Today, while pure mechanical keratomileusis is rarely performed due to these refinements, its principles form the basis for the majority of refractive surgeries worldwide, such as LASIK, emphasizing precise corneal modification to achieve emmetropia without external aids like glasses or contacts.[1]
History
Origins and Development
Keratomileusis was invented in 1948 by Spanish ophthalmologist José Ignacio Barraquer at the Instituto Barraquer in Bogotá, Colombia, marking the first surgical method to sculpt the corneal stroma for correcting refractive errors.[5] Barraquer, often regarded as the father of modern refractive surgery, developed this technique to alter the cornea's curvature and refractive power without relying on external lenses or implants.[6] His work built on earlier ideas of corneal reshaping but introduced a precise, subtractive approach to stromal tissue modification.[7]The initial procedure, known as cryokeratomileusis, involved manually extracting a thin corneal lenticule using a microkeratome—a precision blade instrument also invented by Barraquer—to create a lamellar flap.[2] The excised tissue was then frozen with liquid nitrogen to harden it, allowing reshaping on a specialized device called a cryolathe, which lathe-cut the posterior surface to the desired curvature before thawing and reimplanting the lenticule into the stromal bed.[8] This cryogenic process aimed to flatten the central cornea for myopic correction by reducing its anterior curvature.[7]A pivotal innovation was Barraquer's "Law of Refracting Curves," a theoretical framework using trigonometric calculations to determine the precise corneal reshaping required for specific changes in refractive power, ensuring biomechanical stability and optical predictability.[9] The first human application occurred in 1964, when Barraquer successfully performed myopic keratomileusis on a patient with high myopia, achieving significant refractive improvement and establishing clinical viability.[10]Despite these advances, early cryokeratomileusis faced substantial challenges, including a high risk of postoperative infection due to the invasive lamellar dissection and open stromal exposure.[11] The freezing process often led to irregular healing, with complications such as keratocyte loss, Bowman's membrane disruptions, and epithelial irregularities that delayed recovery and increased astigmatism risk.[12] Initially focused on high myopia, the technique's technical demands and complication rates limited its widespread adoption until refinements emerged. This foundational manual method paved the way for non-cryogenic and laser-based evolutions in the 1980s.[5]
Evolution to Modern Techniques
Building upon the foundational techniques established by José Barraquer in the mid-20th century, keratomileusis evolved significantly in the late 1960s with the introduction of non-freeze methods. Russian ophthalmologist Svyatoslav Fyodorov advanced refractive surgery during this period by developing non-freeze keratomileusis, which utilized mechanical microkeratomes to reshape the cornea in situ without the need for cryogenic freezing, thereby reducing procedural complications and improving precision over earlier freeze-based approaches.[13]The 1980s marked a pivotal shift toward laser integration, beginning with the introduction of the excimer laser in 1983 by researchers at IBM, including physicist Rangaswamy Srinivasan, and ophthalmologist Stephen Trokel, who demonstrated its capability for precise photoablation of corneal tissue without thermal damage. This innovation laid the groundwork for photorefractive keratectomy (PRK) in 1985, the first laser-based refractive procedure, which directly ablated the corneal surface to correct myopia and other errors, offering greater accuracy and faster recovery compared to mechanical methods.[14][15]In the 1990s, the technique culminated in the creation of laser-assisted in situ keratomileusis (LASIK) by Greek surgeon Ioannis Pallikaris in 1990, which combined microkeratome-created corneal flaps with excimer laser ablation beneath the flap for stromal reshaping, minimizing surface disruption and enhancing postoperative comfort. The U.S. Food and Drug Administration (FDA) approved LASIK for myopia correction in 1999, with expansions to hyperopia and astigmatism by 2002, facilitating broader clinical application.[16][17]Post-2000, global adoption of LASIK surged, driven by the 2001 FDA approval of the IntraLase femtosecond laser for precise flap creation, which replaced mechanical microkeratomes with ultrafast pulses to produce more uniform and customizable flaps, further reducing risks and improving outcomes worldwide.[18]
The cornea is a dome-shaped, avascular, and transparent tissue that serves as the outermost layer of the eye's anterior surface, protecting internal structures while contributing significantly to the eye's optical system. It is avascular, relying on tear film and aqueous humor for nourishment, and its transparency is maintained by the precise, ordered arrangement of its cellular and extracellular components. The cornea comprises five primary layers, each with distinct structural and functional roles: the epithelium, Bowman's layer, stroma, Descemet's membrane, and endothelium.[19][20]The outermost layer, the epithelium, is a non-keratinized stratified squamous epithelium approximately 50-60 micrometers thick, functioning as a protective barrier against environmental insults, pathogens, and mechanical stress while allowing rapid regeneration. Beneath it lies Bowman's layer, an acellular, condensed layer of collagen fibers about 8-12 micrometers thick, which provides tensile strength and separates the epithelium from the underlying stroma. The stroma constitutes roughly 90% of the corneal thickness, measuring around 450-500 micrometers centrally, and is composed of densely packed, parallel collagenfibrils arranged in lamellae that ensure optical clarity through minimal light scattering and maintain the cornea's curvature via their biomechanical properties.[19][21][20]Deep to the stroma is Descemet's membrane, a thin, elastic basement membrane secreted by the endothelium, typically 5-10 micrometers thick in adults, which acts as a supportive boundary. The innermost endothelium is a single layer of hexagonal cells, about 4-5 micrometers thick, responsible for pumping ions and fluid out of the stroma to regulate hydration and preserve transparency; its limited regenerative capacity makes endothelial health critical for long-term corneal function.[19][21][20]In terms of refractive properties, the cornea accounts for approximately 70% of the eye's total focusing power, providing about 43 diopters through its anterior surface curvature, with an average central thickness of 550 micrometers and a vertical diameter of 11.5 millimeters. Corneal curvature is quantified in diopters, reflecting the radius of its anterior surface (typically around 7.7 millimeters), which bends incoming light rays to initiate image formation on the retina. The stroma's biomechanical framework, characterized by its anisotropic collagen organization, permits controlled reshaping—such as through precise tissue ablation—while preserving transparency, as long as the fibrillar lattice remains intact and hydration is maintained.[22][23][19]A key prerequisite for procedures involving corneal reshaping, such as keratomileusis, is preoperative pachymetry to measure corneal thickness accurately, ensuring a minimum residual stromal bed of at least 250 micrometers after intervention to mitigate the risk of postoperative ectasia, a condition involving progressive stromal thinning and bulging.[24][25]
Refractive Errors Addressed
Keratomileusis primarily targets refractive errors arising from corneal shape irregularities that prevent light from focusing properly on the retina, allowing surgical reshaping to restore clearer vision.[26]Myopia, or nearsightedness, occurs when the eyeball is elongated or the cornea is too steep, causing light rays to converge in front of the retina and resulting in blurred distant vision. Keratomileusis corrects myopia by flattening the central cornea to adjust the refractive power, effectively managing corrections up to -12 diopters.[27][8]Hyperopia, or farsightedness, results from a shorter eyeball or flatter cornea, leading light rays to focus behind the retina and causing blurred near vision, often with eye strain. This error is addressed through keratomileusis by steepening the central cornea to increase its refractive power, suitable for corrections up to +6 diopters.[28][29]Astigmatism involves an irregular, toric-like corneal curvature that scatters light rays, producing blurred or distorted vision at all distances due to unequal refractive powers in different meridians. Keratomileusis smooths these asymmetric areas to achieve a more spherical corneal profile, correcting up to 6 diopters of cylindrical astigmatism, often in combination with myopia or hyperopia.[30]Presbyopia stems from age-related stiffening of the crystalline lens, reducing the eye's ability to accommodate for near vision, typically affecting individuals over 40; although not a direct corneal issue, it can be managed with monovision keratomileusis, where one eye is corrected for distance and the other slightly undercorrected for near tasks to simulate bifocal vision.[31][32]The primary goal of keratomileusis is to achieve emmetropia, where parallel light rays focus precisely on the retina for normal vision without aids, though customized profiles may optimize outcomes for specific lifestyles or residual errors.[26]
Procedure
Preoperative Preparation
Preoperative preparation for keratomileusis involves a thorough assessment to ensure patient suitability and minimize risks, focusing on both ocular and systemic factors. A comprehensive eye examination is essential, including refraction to determine the precise degree of refractive error, corneal topography to map the corneal curvature and detect irregularities such as subclinical keratoconus, pachymetry to measure corneal thickness (typically around 550 microns in healthy corneas), assessment of pupil size using infrared pupillometry to evaluate night vision risks, and tear film analysis via tests like tear break-up time and Schirmer's test to identify dry eye syndrome.[33][26] These evaluations help confirm that the procedure can effectively address common refractive errors like myopia, hyperopia, and astigmatism.[33]Patient history screening is critical to identify contraindications, such as unstable refraction (requiring stability within 0.5 diopters for at least one year), dry eye disease, autoimmune disorders (e.g., rheumatoid arthritis), pregnancy, or uncontrolled systemic conditions like diabetes.[33][26] Additional inquiries cover ocular history (e.g., previous infections or surgeries) and lifestyle factors, including participation in contact sports, which may contraindicate flap-based keratomileusis due to the risk of flap dislocation.[34]Informed consent follows these assessments, with surgeons discussing realistic expectations, potential outcomes, and risks, including the need for enhancement procedures in approximately 1-5% of cases for residual refractive error, particularly in myopic corrections.[35] Patients are educated on lifestyle implications and the importance of adherence to postoperative care.Preparatory measures include discontinuing soft contact lenses for 1-2 weeks and rigid gas-permeable lenses for 3-4 weeks prior to evaluation to allow corneal stabilization.[26] If allergies are present, prophylactic antibiotics or antihistamines may be prescribed, and dilating drops are used during topography for accurate pupil and mapping assessments.[33]
Surgical Technique
Keratomileusis involves creating a partial-thickness incision in the cornea to access and reshape the stromal layer, altering its curvature to correct refractive errors. The specific steps vary between traditional non-laser methods and modern laser-assisted variants (detailed further in the Types section). Both share initial steps of local anesthesia and stabilization but differ in tissue access and modification.[2]In the original non-laser technique developed by José Ignacio Barraquer, a microkeratome with a suction ring is used to excise a free corneal cap (typically 0.2–0.3 mm thick) from the anterior stroma. The cap is removed, frozen using a cryolathe for rigidity, and mechanically lathe-carved to the desired curvature based on preoperative calculations. After thawing, the reshaped cap is repositioned onto the stromal bed and secured, often without sutures, allowing natural adhesion. This extracorporeal method was precise but technically demanding and is rarely performed today.[2]In the prevalent modern laser-assisted form (laser-assisted in situ keratomileusis or LASIK), the procedure is performed under sterile conditions in an outpatient setting. It commences with the administration of topical anesthetic eye drops, typically proparacaine, to achieve local anesthesia and ensure patient comfort without the requirement for general anesthesia or sedation beyond mild oral anxiolytics if needed.[26] An eyelid speculum is inserted to maintain the eye in an open position, and a suction ring is applied to stabilize the globe and facilitate the subsequent flap creation.[36]The core of the technique involves creating a partial-thickness corneal flap to access the stromal bed. This is accomplished using either a mechanical microkeratome, which employs an oscillating blade, or a femtosecond laser that generates photodisruptive bubbles to form a clean incision plane. The flap is typically hinged nasally or superiorly, with a thickness ranging from 100 to 180 microns to preserve adequate residual stromal bed, and a diameter of 8 to 9 mm to encompass the pupillary area and optical zone. Once created, the flap is gently lifted with a spatula, exposing the underlying stroma for reshaping while minimizing trauma to the corneal epithelium.[36][37][38]Reshaping of the stroma is performed using an excimer laser emitting at a 193 nm ultravioletwavelength, which photoablates tissue through molecular dissociation without thermal damage. The laser pulses are directed based on preoperative corneal topography or wavefront aberrometry mapping to customize the correction pattern for the patient's specific refractive error. Ablation duration generally ranges from 10 to 60 seconds per eye, with the depth of tissue removal estimated at approximately 12 to 14 microns per diopter of correction, depending on the optical zone size and laser platform.[39][40][39]Following ablation, the corneal flap is meticulously repositioned to its original bed, where it adheres naturally via the corneal extracellular matrix without the need for sutures, promoting rapid healing. If any epithelial irregularities are noted, a protective soft contact lens may be applied temporarily to aid re-epithelialization. The entire surgical process per eye typically takes 10 to 15 minutes, enabling sequential treatment of both eyes on the same day.[26][36][40]
Types
Traditional Non-Laser Methods
Traditional non-laser keratomileusis techniques emerged in the mid-20th century as pioneering approaches to refractive correction by mechanically reshaping the cornea. Cryokeratomileusis, developed by Spanish ophthalmologist José Ignacio Barraquer in the 1960s, involved extracting a thin lenticule from the patient's cornea using a microkeratome, freezing it to approximately -196°C on a cryolathe, lathe-turning the frozen tissue to achieve the desired curvature for myopia or hyperopia correction, thawing it, and suturing it back into place.[26][41] This method aimed to alter the corneal refractive power by modifying the stromal thickness, with initial clinical results reported in 1964.[41]Planar keratomileusis, introduced in the 1970s and refined in the 1980s through the non-freeze Barraquer-Krumeich-Swinger (BKS) system by researchers including Casimir A. Swinger, eliminated the freezing step to reduce tissue damage.[41] The procedure utilized a flat-bed microkeratome to create a uniform-thickness planar cut on an inverted corneal disc placed over a supportive die, allowing mechanical reshaping of the posterior surface with precise tools such as a diamond knife to adjust curvature without cryolathing.[41] The reshaped disc was then repositioned and secured, offering improved predictability for moderate refractive errors compared to earlier frozen techniques.[8]Keratophakia, another Barraquer innovation from the 1960s, focused on implanting a pre-shaped donor corneal lenticule to correct aphakia or high hyperopia.[26] In this approach, a donor cornea was lathed into a convex lens shape after freezing, then inserted into a stromal pocket created in the recipient's cornea via microkeratome dissection, without removing the patient's own tissue cap.[41] This alloplastic-like method could address corrections up to 28 diopters but was primarily reserved for cases like post-cataract aphakia.[41]These techniques, while groundbreaking, carried significant limitations that contributed to their obsolescence by the 1990s. Surgical times often exceeded 1-2 hours due to manual precision requirements and suturing, increasing patient discomfort and operative risks.[8] The use of sutures heightened infection risks and induced irregular astigmatism in 7-14% of cases from uneven healing or tissue distortion, particularly with freezing-induced damage in cryokeratomileusis.[41] Overall, inconsistent outcomes and higher complication rates, including corneal haze and loss of best-corrected vision, led to their replacement by laser-assisted variants.[41]
Laser-Assisted Variants
Laser-assisted variants of keratomileusis integrate excimer and femtosecond lasers to enhance precision in corneal reshaping, building on traditional mechanical techniques by minimizing tissue trauma and improving refractive outcomes.[42]LASIK (Laser-Assisted In Situ Keratomileusis) involves creating a hinged corneal flap, typically 90–160 μm thick, using a femtosecond laser or microkeratome, followed by lifting the flap to expose the underlying stroma for excimer laser ablation tailored to the patient's refractive error. The ablation reshapes the corneal curvature in situ, and the flap is then repositioned without sutures, allowing rapid epithelialization and visual recovery within hours to days. This procedure corrects myopia up to -12 diopters, hyperopia up to +6 diopters, and astigmatism up to 6 diopters, with over 95% of patients achieving uncorrected visual acuity of 20/40 or better.[26][42]LASEK (Laser-Assisted Subepithelial Keratectomy) employs a dilute alcohol solution (typically 18–20% ethanol) to loosen the corneal epithelium, which is then gently peeled back as a thin flap using a trephine and spatula, exposing Bowman's layer and anterior stroma for excimer laserablation. After reshaping, the epithelial sheet is repositioned, and a bandagecontact lens is placed to promote regrowth over 3–5 days, reducing haze formation compared to earlier surface ablations. LASEK is particularly suited for patients with thin corneas or those at risk of flap complications, offering efficacy similar to photorefractive keratectomy with less stromal removal.[43][44][42]Epi-LASIK utilizes a mechanical epikeratome or blunt separator to create an epithelial flap without alcohol, preserving the epithelial basement membrane and minimizing chemical toxicity while exposing the stroma for excimer laser treatment. The flap is repositioned post-ablation, similar to LASEK, but this alcohol-free approach may reduce postoperative pain and inflammation in the early hours, though visual recovery timelines align closely with LASEK by one month. It is advantageous for patients with thin corneas or dry eye predisposition, providing comparable refractive predictability to other surface ablations.[45][46][47]SMILE (Small Incision Lenticule Extraction) employs a femtosecond laser to create an intrastromal lenticule within the intact cornea, defined by posterior and anterior surfaces connected by side-cut margins, which is then extracted through a 2–4 mm arcuate incision without flap creation. This flapless technique preserves more anterior corneal nerves and biomechanics, reducing postoperative dry eye incidence compared to LASIK, and is FDA-approved for myopia from -1 to -10 diopters and astigmatism up to -3 diopters, achieving 95% of eyes within 0.5 diopters of target refraction at 12 months.[48][49][42]Customization in these laser-assisted procedures enhances outcomes for complex cases. Wavefront-guided LASIK uses aberrometry to map and correct higher-order aberrations, such as spherical aberration and coma, potentially improving contrast sensitivity and night vision beyond standard ablation profiles.[50][51] Topography-guided variants, like Contoura Vision, address irregular astigmatism by customizing ablation based on corneal elevation maps, significantly reducing cylinder and enhancing uncorrected visual acuity in post-surgical irregularities.[52][53] For presbyopia, monovision LASIK intentionally sets one eye for distance and the other for near vision (typically 1.5–2.5 diopters anisometropia), achieving spectacle independence in 80–90% of suitable emmetropic or low-myopic patients with high satisfaction rates.[54][55]
Indications and Patient Selection
Suitable Refractive Conditions
Keratomileusis, particularly its laser-assisted variants such as LASIK, is primarily indicated for the correction of mild to moderate myopia, typically ranging from -1 to -10 diopters (D), where the procedure reshapes the cornea to reduce excessive curvature and improve focus on distant objects. Traditional non-laser methods historically addressed higher myopia up to -16 D. It is also suitable for hyperopia between +1 and +6 D, addressing insufficient corneal curvature that causes light to focus behind the retina, as well as astigmatism up to 5 D, which involves irregular corneal shape leading to blurred vision at all distances. These refractive errors must be stable for at least one year prior to surgery to ensure predictable outcomes and minimize regression.[26][56][57][58]Ideal patients are generally between 18 and 55 years of age, with healthy corneas measuring more than 480 microns in thickness to accommodate the surgical reshaping without compromising structural integrity. Candidates should have no severe dry eye syndrome, as this could affect healing and visual quality. Professions requiring unaided vision, such as pilots and athletes, often benefit most, as the procedure eliminates the need for glasses or contacts in active environments. This patient profile ensures optimal safety and efficacy, with the corneal anatomy providing adequate tissue for precise modification.[8][59]Overall success rates are high, with approximately 99% of patients achieving uncorrected visual acuity of 20/40 or better and over 90% reaching 20/20 as of 2016 data, demonstrating the procedure's reliability for suitable candidates.[60][61]
Contraindications and Risks
Keratomileusis, a corneal refractive surgery involving the reshaping of the corneal stroma, has specific absolute contraindications where the procedure is not recommended due to significantly elevated risks outweighing potential benefits. These include corneal ectatic disorders such as keratoconus, which compromise corneal integrity and increase the likelihood of postoperative ectasia.[62] Active ocular infections, including herpetic keratitis, pose a high risk of exacerbation or spread during surgery.[62] Uncontrolled systemic autoimmune diseases, such as rheumatoid arthritis, impair wound healing and elevate complication rates.[63] Additionally, pregnancy or breastfeeding is contraindicated due to hormonal influences on refractive stability and potential fetal exposure to medications.[64]Relative contraindications involve conditions that may allow surgery after careful evaluation but warrant heightened caution. Thin central corneal thickness, typically less than 480 microns, limits the amount of tissue available for reshaping and risks postoperative ectasia or flap complications.[65] High myopia exceeding -12 diopters increases the ablation depth required, potentially leading to insufficient residual stromal bed.[66] Unstable refraction, defined as changes greater than 0.5 diopters within the past year, indicates unpredictable outcomes.[62] Severe dry eye syndrome compromises ocular surface integrity and healing, often necessitating deferral until managed.[63]Certain patient-specific risk factors further influence candidacy and require preoperative screening to assess suitability. Age extremes, such as under 18 years or over 60 years, are associated with refractive instability in youth and reduced healing capacity in the elderly, respectively.[34] Large scotopic pupil sizes greater than 7 mm heighten the risk of postoperative halos and glare due to ablation zone limitations.[67]Monocular patients face amplified consequences from any unilateral complication, making the procedure relatively inadvisable without compelling need.[64]Overall, keratomileusis carries a low risk profile, with vision-threatening complications occurring in less than 1% of cases.[61] Preoperative screening, including corneal topography and pachymetry, is essential to identify these contraindications and mitigate risks.[59]
Complications
Intraoperative Issues
Intraoperative issues in keratomileusis primarily apply to its modern laser-assisted variant, laser-assisted in situ keratomileusis (LASIK), during the creation of the corneal flap and laser ablation phases, though traditional non-laser methods (e.g., cryolathe keratomileusis) carry distinct risks such as lenticule tears (reported in ~1-13% of early cases) and epithelial inclusions (~1.6%).[68][69] In LASIK, complications can arise from mechanical, suction-related, or alignment errors, with an overall intraoperative complication rate reported between 0.7% and 6.6%.[70] These challenges are more common in traditional microkeratome-based procedures but have decreased with femtosecond laser adoption.[71]Flap complications represent the most frequent intraoperative problems in LASIK, primarily involving incomplete cuts such as buttonholes, where the microkeratome blade creates a superficial incision without fully penetrating the stroma, occurring in approximately 0.1% to 2% of cases depending on flap thickness and device.[72][73] Buttonholes are often linked to steep corneas, prior corneal scars, or suction instability, and may result in irregular astigmatism if not addressed promptly.[74] Free flaps, characterized by complete detachment without a hinge, are rarer at less than 1% incidence (e.g., 0.08% in large series), typically due to suction loss during the microkeratome pass.[73][75]Suction loss itself, which can lead to these incomplete or free flaps, affects about 0.5% to 1% of procedures and is exacerbated by patient movement or low intraocular pressure.[76] Management of flap issues generally involves aborting the procedure, repositioning the flap if possible, and rescheduling after epithelial healing, often converting to photorefractive keratectomy (PRK) to avoid further flap manipulation.[70][77]Laser ablation errors in LASIK, such as central islands—regions of uneven ablation causing a central steepening—occur in around 5% of cases with older broad-beam lasers but are significantly reduced with modern scanning excimer lasers.[78] Decentration, or misalignment of the ablation zone, affects less than 1% of treatments and can induce higher-order aberrations, though eye-tracking systems mitigate this by dynamically adjusting for eye movement during ablation.[79]Other intraoperative concerns in LASIK include rare corneal perforations (<0.1%), often from excessive microkeratome depth in thin corneas, requiring immediate suction release and potential surgical repair.[80] Epithelial defects from the suction ring, induced by mechanicaltrauma or dehydration under the operating microscope, occur in 0.6% to 14% of cases but are less frequent with femtosecond lasers; these are managed with bandagecontact lenses and lubricants to promote re-epithelialization without delaying the procedure.[70] Overall, prompt recognition and standardized protocols, including intraoperative tonometry to confirm suction adequacy, minimize visual acuity loss from these issues.[81] In traditional keratomileusis, additional risks include delayed corneal sensitivity recovery due to freezing and higher initial loss of refractive correction (up to 15% in the first year).[82][41]
Postoperative Side Effects
Following keratomileusis, particularly in its laser-assisted in situ (LASIK) form, patients commonly experience temporary dry eyes affecting 50-95% immediately post-operatively due to disruption of corneal nerves during flap creation and ablation, leading to reduced tear production and sensation; symptoms typically peak in the first 1-3 months and resolve within 3-6 months with artificial tears or punctal plugs.[83][84]Night vision disturbances, such as halos and glare around lights, occur in 25-35% of cases, resulting from pupil dilation beyond the treated optical zone, which scatters light; these effects are most pronounced in the early postoperative period and usually diminish within weeks to months as the cornea stabilizes.[85][86]Refractive regression, characterized by a gradual myopic shift primarily driven by central epithelial hyperplasia that compensates for stromal ablation and alters corneal curvature, involves elevated growth factors like hepatocyte and keratinocyte growth factors, leading to epithelial thickening of approximately 6-10 μm, which can induce up to 1 diopter of regression per 10 μm increase; rates vary but affect a notable subset of patients over 1-5 years.[87][88][89]Inflammatory complications like diffuse lamellar keratitis (DLK), often termed "sands of the Sahara" for its fine, grainy white infiltrates under the flap, arise in 1-2% of LASIK cases, typically 1-2 days postoperatively due to noninfectious debris or inflammatory response at the interface.[90][91] Treatment involves frequent topical corticosteroids to halt progression through stages of increasing stromal haze, with flap lift and irrigation reserved for severe grades (III-IV) to prevent scarring and vision loss.[90]Rarer severe effects in LASIK include flap dislocation, occurring in less than 0.1% of cases and usually triggered by trauma such as eye rubbing years post-surgery, which may require urgent repositioning to avoid epithelial ingrowth or irregular astigmatism.[92][93]Corneal ectasia, a progressive thinning and bulging of the cornea, develops in 0.04-0.6% of high-risk cases, linked to preoperative factors like subclinical keratoconus, thin residual stromal bed (<300 μm), or percent tissue altered ≥40%; it manifests as distorted vision months to years later and often necessitates corneal cross-linking or transplantation.[94] Traditional methods also reported ectasia (~1.6% in small series) and epithelial implantation.[68]Postoperative monitoring is essential to detect these effects early, involving slit-lamp examinations at 1 day to assess flap position and inflammation, 1 week for epithelial healing and interface clarity, and 1 month for refractive stability and dry eye resolution.[95][96]
Outcomes and Recovery
Immediate Postoperative Care
In laser-assisted in situ keratomileusis (LASIK), the predominant modern form of keratomileusis, patients receive specific initial instructions to promote healing and prevent complications in the corneal flap or reshaped tissue. They are advised to avoid rubbing or touching the eyes to protect the flap from displacement, and to use preservative-free artificial tears hourly while awake during the first day to alleviate dryness and maintain lubrication. Protective eye shields must be worn at night for one week to minimize accidental trauma during sleep.[97][98]Medications play a key role in immediate management, with topical antibiotic drops prescribed to prevent infection and steroid drops to reduce inflammation, typically administered four times daily for one week. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as topical ketorolac, are recommended for pain relief during the first 24-48 hours. A follow-up appointment with the surgeon is scheduled within 24-48 hours to assess flap position, visual acuity, and early healing.[98][97][99]Activity restrictions are essential to support recovery in the initial postoperative period. Patients should not drive until achieving at least 20/40 vision, typically 1-2 days post-surgery, and someone else must transport them home immediately after the procedure. Screen time and reading should be limited on the first day to reduce eye strain, while swimming or pool exposure is prohibited for two weeks to avoid infection risk. Normal activities like work can often resume the next day if vision permits, but strenuous exercise is deferred for at least one week.[97][100][40]Patients should monitor for normal symptoms, including mild discomfort, tearing, or light sensitivity, which typically peak at 4-6 hours post-surgery and subside within 24 hours; common side effects like transient dryness may occur but improve with lubrication. Increasing pain, redness, or vision loss beyond expected levels warrants immediate medical attention, as these may indicate infection or flap issues such as diffuse lamellar keratitis.[101][102]
Long-Term Efficacy and Follow-Up
Long-term efficacy of keratomileusis, particularly in its laser-assisted form (LASIK), is characterized by high patient satisfaction rates, with studies reporting approximately 96% of patients expressing happiness with their vision quality and willingness to undergo the procedure again after five years.[103] Stability of refractive correction remains strong over extended periods, with about 90% of eyes achieving outcomes within ±2.00 D of the target at 10 years post-surgery for moderate myopia.[27] Enhancements for fine-tuning are required in 10-15% of cases, often due to minor regression, reflecting the procedure's predictability in most patients.[104]Historical non-laser keratomileusis, such as Barraquer's cryolathe method, achieved variable refractive stability with higher enhancement needs due to manual precision limits, though long-term data are limited as the technique is obsolete.[3]Follow-up protocols typically involve monthly assessments for the first three months to monitor healing and refraction, followed by visits at six and twelve months, and annual evaluations thereafter, incorporating refraction and corneal topography to detect any changes.[105] These schedules ensure early identification of issues like under- or over-correction.Long-term data indicate reduced risk of corneal ectasia when using femtosecond laser for flap creation, with incidence rates as low as 0.05% in screened patients, owing to precise flap thickness that preserves more stromal bed integrity compared to mechanical microkeratomes.[106] Regression is minimal in low myopia cases, typically less than 0.5 D per year, allowing sustained visual acuity without significant deterioration.[107]Quality of life improvements include markedly decreased dependence on glasses or contacts, with nearly 95% of patients requiring no distance correction five years post-procedure.[108] In wavefront-guided variants, enhanced contrast sensitivity contributes to better functional vision, particularly in low-light conditions, further elevating patient-reported outcomes.[109] Postoperative side effects, such as transient visual disturbances, generally resolve within months, supporting enduring benefits.[61]