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

Primary Purpose

Myopic Regression

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Timolol
Placebo
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic Regression

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ophthalmic Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Timolol group

Arm Description

included patients who received artificial tear twice a day as control group.

included the patients with myopic regression who received timolol 0.5% eye drop twice a day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2012
Last Updated
January 9, 2012
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01506635
Brief Title
Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial
Official Title
Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Regression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
included patients who received artificial tear twice a day as control group.
Arm Title
Timolol group
Arm Type
Experimental
Arm Description
included the patients with myopic regression who received timolol 0.5% eye drop twice a day
Intervention Type
Drug
Intervention Name(s)
Timolol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
artificial tear twice a day
Primary Outcome Measure Information:
Title
Spherical Equivalent
Description
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.
Time Frame
spherical equivalent at month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22935601
Citation
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.
Results Reference
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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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