GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients
Condition: Corneal Epithelium Defect
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): 0.3% hypromellose
Intervention type(s): Drug
Intervention description(s): 0.3% hypromellose four times a day for 5 days prior to LASIK surgery
Other intervention name(s): Genteal Gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: LASIK; Ocular Lubricants; Corneal Epithelium; Wound Healing