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

Completed · Phase 4

Conditions studied: Corneal Epithelium Defect

In brief

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.

Key facts

Study ID

NCT00598689

Run by

Augusta University

People needed

80

Starts

2007-10-01

Expected to finish

2009-10-01

Last updated by the study team

2016-03-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 - 60
• Both sexes
• Any race
• Seeking LASIK surgery at the Medical College of Georgia (MCG)/Eye Care One
• Meeting all established criteria for appropriateness for LASIK established by MCG/Eye Care One

You may not qualify if…

• Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
• Any immunocompromised state including diabetes mellitus, cancer, HIV infection, or Hepatitis B or C.
• Failure to meet all established criteria for appropriateness for LASIK established by MCG/Eye Care One

Where it is running

• EyeCare One — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.