Tissue Sealant Use in LASIK Enhancement Surgery

Phase 4

Completed

• Conditions: Epithelial Ingrowth
• Interventions: Drug: Tissue sealant

• Registration Number: NCT02952365
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-02
• Primary Completion: 2017-05-22
• Study Completion: 2017-05-22
• Status Verified: 2021-11
• Results First Submitted: 2021-11-15
• Results First Submitted QC: 2021-11-15
• Last Update Submitted: 2021-11-15
• Results First Posted: 2021-12-14
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eyes undergoing LASIK enhancement	Tissue sealant	Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth

Primary Outcome Measures

Name	Time	Method
Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap	At post-operative month 3	The number of eyes that developed epithelial ingrowth under LASIK flap

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States