Tissue Sealant Use in LASIK Enhancement Surgery

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery

Detailed Description
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Participants will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the participant from the study, then the participant will be informed and given an appropriate referral. If the participant is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The participant will undergo LASIK flap lift eye surgery. Tissue sealant will be applied at to the edge of the LASIK flap at the conclusion of the surgery. A bandage contact lens will also be placed. The bandage contact lens is used in the usual and customary fashion as in non-study LASIK flap lift surgery. The participants will be seen on the day of surgery, post op day one, one month, and three months. The participant will receive topical antibiotics in each eye for one week following the procedure. The participant will receive pred forte 1% ophthalmic drops for one week after treatment. The participant will also receive vigamox ophthalmic drops for seven days after treatment. All of this is within the usual and customary standard of care for the treatment of participants undergoing LASIK surgery.

Official Title
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A Prospective Evaluation of Tissue Sealant to Prevent Epithelial Ingrowth in Repeat LASIK Surgery

Conditions
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Epithelial Ingrowth

Intervention / Treatment
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* Drug: Tissue sealant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 21 and older Subjects with healthy eyes Subjects who have previously undergone LASIK surgery Subjects with residual refractive error. Exclusion Criteria: Subjects under the age of 21. Subjects with excessively thin corneas. Subjects with topographic evidence of keratoconus. Subjects with ectatic eye disorders. Subjects with autoimmune diseases. Subjects who are pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eyes undergoing LASIK enhancement<br>Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth | Drug: Tissue sealant<br>* Application of tissue sealant on eyes undergoing LASIK enhancement<br>* Other names: ReSure sealant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap | The number of eyes that developed epithelial ingrowth under LASIK flap | At post-operative month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Refraction | Number of eyes within 0.5 diopters of the intended correction | At post-operative month 3 | 
| Best-corrected Visual Acuity | Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts | At post-operative month 3 | 
| Uncorrected Visual Acuity | Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts | At post-operative month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LASIK, Ingrowth, Tissue sealant