Corneal Epithelium Defect Clinical Trial
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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