Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial
1 other identifier
interventional
45
1 country
1
Brief Summary
In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 4, 2012
CompletedFirst Posted
Study publicly available on registry
January 10, 2012
CompletedJanuary 10, 2012
October 1, 2009
9 months
January 4, 2012
January 9, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Spherical Equivalent
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.
spherical equivalent at month 6
Study Arms (2)
Control group
PLACEBO COMPARATORincluded patients who received artificial tear twice a day as control group.
Timolol group
EXPERIMENTALincluded the patients with myopic regression who received timolol 0.5% eye drop twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
- cataract,
- pregnancy,
- breast feeding
- systemic corticosteroid therapy were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Research Center
Tehran, Tehran Province, 16666, Iran
Related Publications (1)
Shojaei A, Eslani M, Vali Y, Mansouri M, Dadman N, Yaseri M. Effect of timolol on refractive outcomes in eyes with myopic regression after laser in situ keratomileusis: a prospective randomized clinical trial. Am J Ophthalmol. 2012 Nov;154(5):790-798.e1. doi: 10.1016/j.ajo.2012.05.013. Epub 2012 Aug 28.
PMID: 22935601DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 4, 2012
First Posted
January 10, 2012
Study Start
March 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 10, 2012
Record last verified: 2009-10