GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|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|
- Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery [ Time Frame: Day 1, End of Week 1 ] [ Designated as safety issue: No ]Assess whether preoperative GenTeal Gel enhances epithelial healing after LASIK surgery within the first post-operative week, compared to control (no preoperative lubricant). Healing of the area of the cornea covering the radius of the sectioned into clock hours 0 - 12 where 0 hours equals no healing and 12 hours equals complete healing.
- Post Operative Pain Level [ Time Frame: Day 1, End of Week 1 ] [ Designated as safety issue: No ]Assess whether preoperative GenTeal Gel alleviates post operative pain in LASIK surgery patients compared to control (no preoperative lubricant) as measured by patient completion of the Universal Pain Assessment Tool (moderate), a ten point scale with 0 being no pain and 10 being the worst pain possible. Data on the level of pain only in the right eye will be collected.
- Tolerability and Alleviation of Post-operative Pain in LASIK Surgery [ Time Frame: Week 1 post surgery ] [ Designated as safety issue: No ]A comparison of subjective comfort level defined as tolerability and alleviation of post-operative pain experienced as a result of post-operative application of GenTeal drops. Subjective pain level was measured on a 10 point likert scale where 0 = no pain and 10 = worst pain possible. A lower score at Week 1 as compared to Day 1 was considered improved. A same score or higher at week 1 as compared to day 1 was considered no improvement.
|Study Start Date:||October 2007|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.
Drug: 0.3% hypromellose
0.3% hypromellose four times a day for 5 days prior to LASIK surgery
Other Name: Genteal Gel
No Intervention: No Lubricant
Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598689
|United States, Georgia|
|Augusta, Georgia, United States, 30907|
|Principal Investigator:||David D Bogorad, M.D||Georgia Regents University|