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GenTeal in Perioperative Treatment of LASIK Patients

This study has been completed.
Sponsor:
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00598689
First received: January 10, 2008
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

GenTeal gel is an artifical 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.


Condition Intervention Phase
Refractive Surgical Procedures
Drug: 0.3% hypromellose
Other: No Artificial Tears
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Assess whether preoperative GenTeal Gel enhances epithelial healing after LASIK surgery within the first post-operative week, compared to control (no preoperative lubricant). [ Time Frame: 1 day, 1 week , 1 month after LASIK ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess whether preoperative GenTeal Gel alleviates post operative pain in LASIK surgery patients compared to control (no preoperative lubricant). [ Time Frame: 1 day, 1 week, 1 month after LASIK ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Genteal gel four times a day for 5 days prior to LASIK surgery
Drug: 0.3% hypromellose
0.3% hypromellose four times a day for 5 days prior to LASIK surgery
Other Name: Genteal Gel
Drug: 0.3% hypromellose
0.3% hypromellose drops 4 times a day after LASIK surgery
Other Name: GenTeal Solution
No Intervention: 2
No Genteal Gel prior to LASIK surgery
Other: No Artificial Tears
No artificial tears prior to LASIK surgery
Drug: 0.3% hypromellose
0.3% hypromellose drops 4 times a day after LASIK surgery
Other Name: GenTeal Solution

Detailed Description:

LASIK (Laser Keratomielusis 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, Norvatis 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 - 60
  2. Both sexes
  3. Any race
  4. Seeking LASIK surgery at the Medical College of Georgia/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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598689

Locations
United States, Georgia
EyeCare One
Augusta, Georgia, United States, 30907
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: David D Bogorad, M.D Georgia Regents University
  More Information

Publications:
Responsible Party: David D. Bogorad, MD; Associate Professor, Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00598689     History of Changes
Other Study ID Numbers: 07-09-052
Study First Received: January 10, 2008
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
LASIK
Ocular Lubricants
Corneal Epithelium
Wound Healing

Additional relevant MeSH terms:
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014