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Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT01506635
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : January 10, 2012
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK

Condition or disease Intervention/treatment
Myopic Regression Drug: Timolol Drug: Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial
Study Start Date : March 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control group
included patients who received artificial tear twice a day as control group.
Drug: Placebo
artificial tear twice a day
Experimental: Timolol group
included the patients with myopic regression who received timolol 0.5% eye drop twice a day
Drug: Timolol

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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,
  • cataract,
  • pregnancy,
  • breast feeding
  • systemic corticosteroid therapy were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506635

Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01506635     History of Changes
Other Study ID Numbers: 8902
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: October 2009

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents