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

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01506635
First received: January 4, 2012
Last updated: January 9, 2012
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention
Myopic Regression
 Drug: Timolol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • Spherical Equivalent [ Time Frame: spherical equivalent at month 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506635

Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shaheed Beheshti Medical University
  More Information

No publications provided by Shaheed Beheshti Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01506635     History of Changes
Other Study ID Numbers: 8902
Study First Received: January 4, 2012
Last Updated: January 9, 2012
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 21, 2013