Clinical trial NCT00598689: GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients
Official title: Efficacy, Tolerability and Comfort of GenTeal and GenTeal Gel, (0.3% Hypromellose) in the Pre- and Post- Operative Treatment of Patients Undergoing LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corneal Epithelium Defect
Keywords: LASIK
Ocular Lubricants
Corneal Epithelium
Wound Healing
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: LASIK (Laser Keratomileusis in Situ) is a frequently performed procedure to reduce the refractive error of the eye so as to minimize the subsequent need for eyeglasses or contact lenses. The procedure requires the creation of a superficial corneal flap, usually with an instrument known as a microkeratome. During the creation of the flap with a microkeratome, the corneal epithelium is typically subjected to sliding stresses which occasionally cause disruption of the epithelial surface, a complication with potentially serious adverse effect on the post operative visual acuity. As well, shortly before the creation of the flap, the patient is often dilated and invariably treated with topical anesthetics. These agents, and their preservatives, can have a negative effect on corneal epithelial integrity, right before the epithelium must withstand the passage of the microkeratome. Therefore, it is imperative that the epithelium be in the best possible condition prior to the LASIK procedure. For this reason, ocular lubricants may be used for a period of time prior to surgery in order to maximize epithelial health.

In the immediate post-operative period the bond between the newly created flap and the underlying corneal stroma is weak, and the epithelium has just been subjected to the pharmacologic and mechanical stresses noted above. It is imperative that the surface continuity of the epithelium between the edge of the flap and the surrounding surface be restored as rapidly as possible, as reestablishment of an intact epithelial surface minimizes the risks of flap shift, epithelial ingrowth, and infection. For all these reasons, it is a generally accepted standard of care to use aggressive ocular lubrication during the post-operative period in order to maximize the speed of epithelial recovery.

GenTeal Lubricant Eye Drops and GenTeal Gel, (0.3% hypromellose, Novartis Ophthalmics, Basel, Switzerland) provide a natural alternative to preservative-free treatments, with a sodium perborate preservative system and long-lasting action due to the carbomer gelling agent. The perborate preservative, which breaks down to water and oxygen on the ocular surface, essentially delivers a preservative-free lubricant to the eye. This makes the GenTeal products attractive agents for use in the LASIK perioperative period.

Eligibility 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

Primary outcomes:
measure: Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery
timeFrame: Day 1, End of Week 1
Secondary outcomes:
measure: Post Operative Pain Level
timeFrame: Day 1, End of Week 1
measure: Tolerability and Alleviation of Post-operative Pain in LASIK Surgery
timeFrame: Week 1 post surgery
Other outcomes:
Locations:
city: Augusta
country: United States
facility: EyeCare One
state: Georgia
Study officials:
affiliation: Augusta University
name: David D Bogorad, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samuel MA, Kaufman SC, Ahee JA, Wee C, Bogorad D. Diffuse lamellar keratitis associated with carboxymethylcellulose sodium 1% after laser in situ keratomileusis. J Cataract Refract Surg. 2002 Aug;28(8):1409-11. doi: 10.1016/s0886-3350(02)01266-x.