Tissue Sealant Use in LASIK Enhancement Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Epithelial Ingrowth
• Intervention / Treatment: Drug: Tissue sealant

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute at Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Eyes undergoing LASIK enhancement; Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth	Drug: Tissue sealant; Application of tissue sealant on eyes undergoing LASIK enhancement; Other Names: ReSure sealant

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): May 22, 2017
• Study Completion (Actual): May 22, 2017

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: LASIK, Ingrowth, Tissue sealant
• Other Study ID Numbers: IRB-38495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No