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

January 9, 2012 updated by: Shahid Beheshti University of Medical Sciences

Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
spherical equivalent at month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (ESTIMATE)

January 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2012

Last Update Submitted That Met QC Criteria

January 9, 2012

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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