Exposing the LASIK Scam

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PostPosted: Mon Jan 16, 2006 3:43 am 
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J Cataract Refract Surg. 2003 Apr;29(4):808-20. Related Articles, Links


Histological and immunohistochemical findings after laser in situ keratomileusis in human corneas.

Philipp WE, Speicher L, Gottinger W.

Department of Ophthalmology, University of Innsbruck, Austria.

PURPOSE: To describe histopathological and immunohistochemical findings in human corneas after myopic laser in situ keratomileusis (LASIK) followed by iatrogenic keratectasia and after hyperopic LASIK. SETTING: Department of Ophthalmology, University of Innsbruck, Innsbruck, Austria. METHODS: Clinical, histological, and immunohistochemical investigations were performed of 1 human cornea with iatrogenic keratectasia following myopic LASIK and 1 human cornea with irregular astigmatism and central scar formation after hyperopic LASIK. Corneal buttons were obtained during penetrating keratoplasty in both patients. RESULTS: Histopathological examination showed thinning of the central stroma with a posterior residual thickness of 190 microm in the patient with iatrogenic keratectasia after myopic LASIK and significant midperipheral thinning in the patient who had hyperopic LASIK. However, this characteristic ablation profile of the stroma after hyperopic LASIK was partially mitigated and compensated by the epithelium, which was significantly thinned in the center and markedly thickened in the midperiphery. Traces of wound healing with minimal scar tissue were present at the flap margin after myopic and hyperopic LASIK. In a few sections of the cornea with keratectasia after myopia LASIK, only a few collagen lamellae were visible crossing between the posterior residual stroma and the superficial flap. Immunohistochemical examination revealed minimally increased staining of dermatan sulfate proteoglycan within the stroma adjacent to the interface of the microkeratome incision. Increased staining of hepatocyte growth factor was found on keratocytes/fibroblasts at the flap margin in both corneas. CONCLUSIONS: The wound-healing response is generally poor after LASIK, which may result in significant weakening of the tensile strength of the cornea after myopic LASIK, probably due to biomechanically ineffective superficial lamella. After LASIK in patients with high hyperopia, compensatory epithelial thickening in the annular midperipheral ablation zone might be partly responsible for regression.

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PostPosted: Mon Jan 16, 2006 4:01 am 
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Cornea. 2002 Aug;21(6):604-7.


Late-onset traumatic flap dislocation and diffuse lamellar inflammation after laser in situ keratomileusis.

Aldave AJ, Hollander DA, Abbott RL.

Department of Ophthalmology, The University of California-San Francisco, San Francisco, California, U.S.A. aaldave@pol.net

PURPOSE: To report a case of traumatic flap partial dislocation and subsequent diffuse lamellar inflammation 14 months after laser in situ keratomileusis (LASIK) retreatment. METHODS: Case report of a late flap dislocation that occurred during routine recreational activity (struck with a finger in the right eye while playing basketball). RESULTS: The partially dislocated LASIK flap was reflected nasally, and the stromal surfaces of the flap and bed were thoroughly scraped to remove debris and epithelial cells. The flap was repositioned, and a bandage contact lens was placed. Diffuse lamellar inflammation, which developed on post-trauma day number two, was successfully treated with frequent topical steroids. Three weeks after the injury, the patient had regained 20/20 uncorrected visual acuity. CONCLUSIONS: Patients should be appropriately warned of the possibility of late flap dislocation with traumatic forces encountered during routine recreational activities. Full visual recovery is possible if the dislocation is promptly diagnosed and appropriately managed.

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PostPosted: Mon Jan 16, 2006 4:16 am 
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J Cataract Refract Surg. 2001 Aug;27(8):1323-7.


Ultrastructure of the lamellar corneal wound after laser in situ keratomileusis in human eye.

Rumelt S, Cohen I, Skandarani P, Delarea Y, Ben Shaul Y, Rehany U.

Department of Ophthalmology, Western Galilee-Nahariya Medical Center, Israel.

A 30-year-old patient with keratoconus, a stable refraction, and normal central corneal thickness had laser in situ keratomileusis (LASIK). Six months later, she had uneventful penetrating keratoplasty for keratectasia. The lamellar LASIK interface could not be clearly identified by light microscopy. The corneal wound site did not stain for methyl metalloproteinase 1 or 2. Both the corneal flap undersurface and the stromal bed were devoid of interconnections and cells. Throughout the lamellar incision, including the laser-ablated zone, the surface was smooth on scanning electron microscopy. The collagen fibrils on both sides of the incision remained well aligned with one another, indicating good flap apposition. Under higher magnification transmission electron microscopy, some collagen fragments were found in the interface, especially adjacent to the hinge. The diameter of the collagen fibrils along the lamellar wound were identical to those farther from the incision. The absence of bridging collagen fibrils and cells between the flap undersurface and the stromal bed confirms the clinically known lack of wound repair at the interface and explains the easy separation of the flap from the stromal bed months after LASIK and the possible formation of an interface fluid pocket.

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PostPosted: Mon Feb 13, 2006 3:03 am 
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What a dilemma for LASIK patients -- accept the risk of dislodging your flaps or disconnect your air bag to protect your corneas and put your life in danger.


Am J Ophthalmol. 2000 Aug;130(2):234-5.


Air bag-induced corneal flap folds after laser in situ keratomileusis.

Norden RA, Perry HD, Donnenfeld ED, Montoya C.

Department of Ophthalmology, University of Medicine and Dentistry, New Jersey, Newark, New Jersey, USA. lasik@ibm.net

PURPOSE: We describe a case of air bag-induced ocular trauma resulting in folds in the corneal flap 3 weeks after laser in situ keratomileusis.

METHODS: Case report. Three weeks after laser in situ keratomileusis, a 20-year-old man was involved in a motor vehicle accident and sustained blunt trauma to the right eye, which caused corneal flap folds, corneal edema, anterior chamber cellular reaction, and Berlin retinal edema.

RESULTS: Six weeks after laser in situ keratomileusis, persistent flap folds necessitated re-operation with lifting of the flap and repositioning. One week after the procedure, the visual acuity improved to 20/20-2, and the folds had cleared.

CONCLUSION: Trauma after laser in situ keratomileusis may produce folds in the corneal flap. With persistence of these folds, management by lifting and repositioning the corneal flap may be necessary to permit recovery of visual acuity.

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Bill

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith


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PostPosted: Mon Feb 13, 2006 3:10 am 
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J Refract Surg. 2000 May-Jun;16(3):373-4.


Partial dislocation of laser in situ keratomileusis flap by air bag injury.

Lemley HL, Chodosh J, Wolf TC, Bogie CP, Hawkins TC.

Department of Ophthalmology, Dean A. McGee Eye Institute, University of Oklahoma Health Sciences Center, Oklahoma City, USA.

PURPOSE: A patient developed significant corneal complications from air bag deployment, 17 months after laser in situ keratomileusis (LASIK).

METHODS: Case report, slit-lamp microscopy, and review of the medical literature.

RESULTS: A 37-year-old woman underwent bilateral LASIK with resultant 20/20 uncorrected visual acuity. Seventeen months later, she sustained facial and ocular injuries from air bag deployment during a motor vehicle accident. Examination revealed bilateral corneal abrasions, partial dislocation of the right corneal LASIK flap, and a hyphema in the right eye. The LASIK flap was realigned, but recovery was complicated by a slowly healing epithelial defect and flap edema. One month following the injury, epithelial ingrowth beneath the LASIK flap was noted. Surgical elevation of the flap and removal of the epithelial ingrowth was performed. Eight months later, epithelial ingrowth was absent and the visual acuity was 20/40. Residual irregular astigmatism necessitated rigid gas permeable contact lens fitting to achieve 20/20 visual acuity.

CONCLUSIONS: Air bags may cause significant ocular trauma. The wound healing response of LASIK allows corneal flap separation from its stromal bed for an indeterminate time after surgery. Discussion of the possible risk of corneal trauma as part of informed consent prior to LASIK may be appropriate.

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Bill

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith


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PostPosted: Wed Feb 15, 2006 1:54 am 
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Cornea. 2005 Jul;24(5):509-22.


Wound healing in the cornea: a review of refractive surgery complications and new prospects for therapy.

Netto MV, Mohan RR, Ambrosio R Jr, Hutcheon AE, Zieske JD, Wilson SE.

The Cole Eye Institute, The Cleveland Clinic Foundation, OH 44195, USA.

PURPOSE: The corneal wound healing response is of particular relevance for refractive surgical procedures since it is a major determinant of efficacy and safety. The purpose of this review is to provide an overview of the healing response in refractive surgery procedures.

METHODS: Literature review.

RESULTS: LASIK and PRK are the most common refractive procedures; however, alternative techniques, including LASEK, PRK with mitomycin C, and Epi-LASIK, have been developed in an attempt to overcome common complications. Clinical outcomes and a number of common complications are directly related to the healing process and the unpredictable nature of the associated corneal cellular response. These complications include overcorrection, undercorrection, regression, corneal stroma opacification, and many other side effects that have their roots in the biologic response to surgery. The corneal epithelium, stroma, nerves, inflammatory cells, and lacrimal glands are the main tissues and organs involved in the wound healing response to corneal surgical procedures. Complex cellular interactions mediated by cytokines and growth factors occur among the cells of the cornea, resulting in a highly variable biologic response. Among the best characterized processes are keratocyte apoptosis, keratocyte necrosis, keratocyte proliferation, migration of inflammatory cells, and myofibroblast generation. These cellular interactions are involved in extracellular matrix reorganization, stromal remodeling, wound contraction, and several other responses to surgical injury.

CONCLUSIONS: A better understanding of the complete cascade of events involved in the corneal wound healing process and anomalies that lead to complications is critical to improve the efficacy and safety of refractive surgical procedures. Recent advances in understanding the biologic and molecular processes that contribute to the healing response bring hope that safe and effective pharmacologic modulators of the corneal wound healing response may soon be developed.

********************************************

From the conclusion:

Quote:
Recent advances in understanding the biologic and molecular processes that contribute to the healing response bring hope that safe and effective pharmacologic modulators of the corneal wound healing response may soon be developed.


Wouldn't you think they'd want to figure this out before performing refractive surgeons on millions and millions of patients?

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Wed Feb 15, 2006 1:59 am 
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Cornea. 2005 Jan;24(1):92-102.


Pathologic findings in postmortem corneas after successful laser in situ keratomileusis.

Kramer TR, Chuckpaiwong V, Dawson DG, L'Hernault N, Grossniklaus HE, Edelhauser HF.

Emory Eye Center, Emory University, Atlanta, GA 30322, USA. Theresa_Kramer@emoryhealthcare.org

PURPOSE: To examine the histologic and ultrastructural features of human corneas after successful laser in situ keratomileusis (LASIK).

METHODS: Corneas from 48 eyes of 25 postmortem patients were processed for histology and transmission electron microscopy (TEM). The 25 patients had LASIK between 3 months and 7 years prior to death. Evaluation of all 5 layers of the cornea and the LASIK flap interface region was done using routine histology, periodic acid-Schiff (PAS)-stained specimens, toluidine blue-stained thick sections, and TEM.

RESULTS: In patients for whom visual acuity was known, the first postoperative day uncorrected visual acuity was 20/15 to 20/30. In patients for whom clinical records were available, the postoperative corneal topography was normal and clinical examination showed a semicircular ring of haze at the wound margin of the LASIK flap. Histologically, the LASIK flap measured, on average, 142.7 microm (range, 100-200). A spectrum of abnormal histopathologic and ultrastructural findings was present in all corneas. Findings at the flap surface included elongated basal epithelial cells, epithelial hyperplasia, thickening and undulations of the epithelial basement membrane (EBM), and undulations of Bowman's layer. Findings in or adjacent to the wound included collagen lamellar disarray; activated keratocytes; quiescent keratocytes with small vacuoles; epithelial ingrowth; eosinophilic deposits; PAS-positive, electron-dense granular material interspersed with randomly ordered collagen fibrils; increased spacing between collagen fibrils; and widely spaced banded collagen. There was no observable correlation between postoperative intervals and the severity or type of pathologic change except for the accumulation the electron-dense granular material.

CONCLUSIONS: Permanent pathologic changes were present in all post-LASIK corneas. These changes were most prevalent in the lamellar interface wound. These changes along with other pathologic alterations in post-LASIK corneas may change the functionality of the cornea after LASIK.


BE's comment:
From the abstract:
Quote:
There was no observable correlation between postoperative intervals and the severity or type of pathologic change except for the accumulation the electron-dense granular material.


I believe this statement is significant because it points out that the damage and abnormal findings after LASIK did not improve from 3 months post-op to the endpoint of 7 years post-op.

THE CORNEA DOES NOT HEAL.

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject: GOAT REMOVES LASIK FLAP
PostPosted: Fri Feb 17, 2006 2:59 pm 
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Lost LASIK Flap

By Karl G. Stonecipher, MD

While visiting New Orleans , I received a frantic phone call from one of the physicians covering for me while I was away. A patient?s pet goat had reared its head suddenly, and one of its horns had struck the woman?s right eye. She described sudden pain but no other findings. She had immediately presented to the eye center, and my partner asked me how to proceed.

CASE HISTORY

The patient?s preoperative manifest refraction had been -8.25D sphere OU. Her pachymetry readings were 505?m OD and 510?m OS prior to surgery. Her original LASIK procedure had been uneventful, and her UCVA had measured 20/20 OD and 20/30 OS during her last visit prior to the current injury. I had targeted her left eye for

-0.75D sphere in order to achieve modified monovision. As measured during her previous visit, the patient?s manifest refraction was -0.25D OD and -1.00 +0.50 X 085 OS.

CASE PRESENTATION

Upon examination, my partner noted that the goat?s horn had entirely removed the LASIK flap, which had been created by an Automated Corneal Shaper microkeratome (Bausch & Lomb, Rochester, NY) with a 160-?m head.



You can read the rest at http://www.crstoday.com/PDF%20Articles/0206/CRST0206_focus.html

This woman is probably considered a success by her surgeon.

_________________
Bill

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith


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PostPosted: Thu Mar 16, 2006 1:00 am 
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Ophthalmology. 2005 Jun;112(6):1009-16.

Change in intraocular pressure measurements after LASIK the effect of the refractive correction and the lamellar flap.

Chang DH, Stulting RD.

Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia, USA.

OBJECTIVE: To study the relationship between intraocular pressure (IOP) readings after LASIK and the amount of refractive correction.

DESIGN: Retrospective noninterventional case series. PARTICIPANTS: Patients receiving primary LASIK for myopia and myopic astigmatism.

METHODS: A database of preoperative, intraoperative, and 3-month postoperative data for 8113 consecutive eyes that underwent primary myopic and myopic astigmatic LASIK was retrospectively reviewed. Linear regression analysis of measured IOP change as a function of refractive change was then performed. Age and preoperative keratometry were also reviewed by multiple regression.

MAIN OUTCOME MEASURES: Best-fit curve relating change in measured IOP to refractive change.

RESULTS: The mean spherical equivalent of the refractive change was -4.98+/-2.64 diopters (mean +/- standard deviation). The mean decrease in measured IOP was 2.0+/-3.3 mmHg. Linear regression analysis revealed a decrease of 0.12 mmHg of measured IOP per diopter of refractive change (95% confidence interval [CI], 0.09-0.15, R(2) = 0.009, P<0.001). Extrapolation of the data to a theoretical correction of zero diopters revealed a decrease of 1.36 mmHg (95% CI, 1.20-1.51, P<0.001), suggesting a component of measured IOP change that is independent of laser ablation.

CONCLUSIONS: The reduction of IOP readings after corneal refractive surgery is a linear function of the amount of refractive correction, with an additional constant reduction that is probably related to the lamellar corneal flap. These data suggest that the lamellar corneal flap makes no contribution to the load-bearing characteristics of the post-LASIK cornea.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Sat Mar 25, 2006 6:06 pm 
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Am J Ophthalmol. 2006 Mar 15;

Corneal Keratocyte Deficits After Photorefractive Keratectomy and Laser In Situ Keratomileusis.

Erie JC, Patel SV, McLaren JW, Hodge DO, Bourne WM.

Department of Ophthalmology (J.C.E., S.V.P., J.W.M., W.M.B.).

PURPOSE: To measure changes in keratocyte density up to 5 years after photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK).

DESIGN: Prospective, nonrandomized clinical trial.

METHODS: Eighteen eyes of 12 patients received PRK to correct a mean refractive error of -3.73 +/- 1.30 diopters, and 17 eyes of 11 patients received LASIK to correct a mean refractive error of -6.56 +/- 2.44 diopters. Corneas were examined by using confocal microscopy before and 6 months, 1 year, 2 years, 3 years, and 5 years after the procedures. Keratocyte densities were determined in five stromal layers in PRK patients and in six stromal layers in LASIK patients. Differences between preoperative and postoperative cell densities were compared by using paired t tests with Bonferroni correction for five comparisons.

RESULTS: After PRK, keratocyte density in the anterior stroma decreased by 40%, 42%, 45%, and 47% at 6 months, 2 years, 3 years, and 5 years, respectively (P < .001). At 5 years, keratocyte density decreased by 20% to 24% in the posterior stroma (P < .05). After LASIK, keratocyte density in the stromal flap decreased by 22% at 6 months (P < .02) and 37% at 5 years (P < .001). Keratocyte density in the anterior retroablation zone decreased by 18% (P < .001) at 1 year and 42% (P < .001) at 5 years. At 5 years, keratocyte density decreased by 19% to 22% (P < .05) in the posterior stroma.

CONCLUSIONS: Keratocyte density decreases for at least 5 years in the anterior stroma after PRK and in the stromal flap and the retroablation zone after LASIK.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Mon Apr 17, 2006 11:39 am 
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The following excerpt is describing lifting a LASIK flap for a retreatment.

Journal of Refractive Surgery, April 2006
RETREATMENT OF LASIK

"If the flap edge still cannot be visualized, a Sinskey hook is dragged from the periphery towards the flap edge carefully with downward pressure; the tip of the instrument will pop into the gutter when the edge is reached."

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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J Refract Surg. 2006 Apr;22(4):402-4.

Traumatic late flap dehiscence and Enterobacter keratitis following LASIK.

Cheung LM, Papalkar D, Versace P.

Department of Ophthalmology, Prince of Wales Hospital, Randwick, Australia.

PURPOSE: To report a case of traumatic flap dehiscence and Enterobacter keratitis 34 months after LASIK.

METHODS: A 36-year-old man sustained a flap dehiscence following traumatic right eye gouging by a seagull claw. He presented the following day with uncorrected visual acuity (UCVA) in the affected eye of 3/200 and organic foreign body deposits underneath the flap. Systemic and topical antibiotics were administered and urgent surgical debridement and replacement of the LASIK flap was performed. An Enterobacter species was cultured from an intraoperative swab.

RESULTS: After a prolonged postoperative course, including administration of topical ofloxacin, tobramycin, chloramphenicol, and dexamethasone, UCVA returned to 20/20.

CONCLUSIONS: Good visual outcome after early debridement and appropriate antibiotics was achieved. Patients should be injury advised to seek prompt ophthalmic consultation after LASIK.

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Tue May 09, 2006 11:40 am 
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Cornea

Volume 25(3), April 2006, pp 331-335

Immunohistochemical Findings After LASIK Confirm In Vitro LASIK Model

Excerpt:


"However, one aspect still in discussion is the wound-healing process in the
created interface that leads to an easily removable flap even years after
treatment."


"The lack of pronounced morphologic changes in the central area of the LASIK
interface, which only showed little accumulation of fibronectin, supports the
hypothesis of reduced wound-healing reactions after performing this surgical
procedure. Only at the rim zone of the incision, scar tissue formation can
appear and might form an incomplete fixation zone for the corneal flap.17,19-22
Due to this impaired healing process, even years after the LASIK procedure, a
corneal flap displacement can occur
.1,2

In summary, our histologic findings confirm the well-known clinical phenomenon
that wound-healing reactions are marginal after uncomplicated LASIK treatment."

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Wed May 10, 2006 11:33 am 
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Am J Ophthalmol. 2006 May;141(5):960-2.


Treatment of traumatic LASIK flap dislocation and epithelial ingrowth with fibrin glue.

Yeh DL, Bushley DM, Kim T.

Duke University Eye Center, Durham, North Carolina.

PURPOSE: To describe a case of a traumatic late dislocation of a laser-assisted in situ keratomileusis (LASIK) flap complicated by epithelial ingrowth.

DESIGN: Interventional case report.

METHODS: A 50-year-old woman presented 21 months after uncomplicated LASIK with painful vision loss in the right eye after minor trauma.

RESULTS: A dislocation of the LASIK flap was noted at examination and was repositioned. One week later, epithelial ingrowth was detected in the flap interface. The ingrowth was treated with flap lifting, debridement, and sealing of the flap with fibrin glue. Visual acuity returned to baseline, and there was no recurrence after 20 months of follow-up.

CONCLUSIONS: Traumatic dislocations of LASIK flaps may occur many months after uncomplicated surgery and may be associated with epithelial ingrowth after successful repositioning. The additional use of fibrin glue in conjunction with thorough debridement may be helpful in preventing the recurrence of epithelial ingrowth.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Wed May 10, 2006 1:25 pm 
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?The LASIK flap never heals? the LASIK flap can be easily dislodged from simple contact with the eye such as a finger poke.?

WebMDHealth http://my.webmd.com/content/article/61/68084.htm .


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