Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)
Information source: Walter Reed Army Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epithelium, Corneal
Intervention: Moxifloxacin (Drug); Gatifloxacin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Walter Reed Army Medical Center Official(s) and/or principal investigator(s):
KRAIG S. BOWER, MD, Principal Investigator, Affiliation: Walter Reed Army Medical Center
Summary
The purpose of this study is a prospective,double-blinded, randomized trial to compare the
rate of healing following PRK after the use of two commercially available 4th generation
fluoroquinolones, moxifloxacin and gatifloxacin.
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Corneal Epithelial Healing Time
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Manifest refraction spherical equivalent (MSE) of up to -6. 00 diopters (D) at the
spectacle plane with refractive cylinder up to 3. 00D.
Exclusion Criteria:
- Concurrent topical or systemic medications that may impair healing including
corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or
sumatripin.
- Patients with known sensitivity or inappropriate responsiveness to any of the
medications used in the post-operative course.
- Anterior basement membrane dystrophy.
- History of recurrent epithelial erosion.
- Significant dry eye (symptomatic sith Schirmer <5mm at 5 minutes)
- Other corneal epithelial disorder or healing abnormality
Locations and Contacts
Walter Reed Army Medical Center, Washington, District of Columbia 20307, United States
Additional Information
Last updated: June 26, 2013
|
