GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

GenTeal gel is an artificial tear gel used to lubricate the surface of the eye. This study will evaluate the effect of GenTeal gel on comfort following LASIK surgery. Participants will be asked to come to the clinic for three regularly scheduled visits after LASIK surgery: Day 1 (one day after LASIK surgery), Day 7 (one week follow-up), and Day 30 (one month follow-up). Participants will be asked to complete a questionnaire regarding eye comfort during each follow up visit. Participants will be randomly assigned to one of two groups, one of which will receive Genteal Gel four times a day for five days prior to surgery. The other group will receive no preoperative gel or lubricant, which has been our standard approach for many years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Augusta University
• Collaborator: Novartis
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

1. Age 18 - 60

2. Both sexes

3. Any race

4. Seeking LASIK surgery at the Medical College of Georgia (MCG)/Eye Care One

5. Meeting all established criteria for appropriateness for LASIK established by MCG/Eye Care One

Exclusion Criteria:

1. Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant

2. Any immunocompromised state including diabetes mellitus, cancer, HIV infection, or Hepatitis B or C.

3. Failure to meet all established criteria for appropriateness for LASIK established by MCG/Eye Care One