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

Myopic Regression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506635
• Other study ID #: 8902
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: January 9, 2012
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2009
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia
• Myopic Regression

Intervention

Drug:
• Timolol

• Placebo
artificial tear twice a day

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No