NCT01506635
Completed
Not Applicable
Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial
Shahid Beheshti University of Medical Sciences1 site in 1 country45 target enrollmentStarted: March 2010Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Spherical Equivalent
Overview
Brief Summary
In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with myopic regression equal or more than 0.5 D with minimum age of 20 years,
- •cylinder ≤ -1.00 D,
- •corrected distance visual acuity (CDVA) of at least 20/40 were included.
Exclusion Criteria
- •Patients with a history of previous ocular surgery,
- •keratoconus or any ectatic corneal disorder,
- •keratoconus suspect by topography,
- •preoperative corneal opacity,
- •any corneal dystrophies,
- •presence of pterygium,
- •retinal disorders,
- •collagen vascular disorders,
- •diabetes mellitus,
- •glaucoma,
Arms & Interventions
Control group
Placebo Comparator
included patients who received artificial tear twice a day as control group.
Intervention: Placebo (Drug)
Timolol group
Experimental
included the patients with myopic regression who received timolol 0.5% eye drop twice a day
Intervention: Timolol (Drug)
Outcomes
Primary Outcomes
Spherical Equivalent
Time Frame: spherical equivalent at month 6
Effect of timolol use in timolol group will be compared with placebo group at month 6. Moreover, the changes of intragroup spherical equivalent will be assessed in both group 6 months after timolol application.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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