Clinical Evaluation of Efficacy of SLT to Topical Medication in Lowering IOP

Glaucoma Clinical Trial

Official title:

A Prospective, Randomized, Controlled Clinical Trial Comparing Topical Medical Therapy With Selective Laser Trabeculoplasty in South Indian Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01639807
• Other study ID #: AEH/SLT/012/2011
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2012
• Last updated: July 11, 2012
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2012
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare Selective laser trabeculoplasty (SLT) and topical medications for initial treatment of open-angle glaucoma /Ocular Hypertension based on intraocular pressure reduction, treatment side effects, quality of life measures and costs in South Indian Population.

Description:

Selective laser trabeculoplasty (SLT), a lasering procedure, is equal to or better than using medication for lowering eye pressure,leading to a better quality of life and being less costly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Diagnosis: POAG, PXF glaucoma, pigmentary glaucoma or mixed mechanism POAG with a narrow angle, (if laser PI > 3 months ago) defined by standard examination criteria Adequate visualization of angle structures (i.e. clear media and cooperative patient) On no glaucoma medications OU > 1 month On no systemic medications known to IOP (steroids) Visual acuity > 6/24 OU Age - more than 35 yrs and less than 72 yrs

Exclusion Criteria:

A cumulative lifetime use of eye drops for glaucoma that exceeded 14 days; Used any eye drops for glaucoma in the 3 weeks before baseline I visit (washout from < 14 days of use will be permitted); CIGTS visual field score that exceeds 16 in either eye; Evidence of ocular disease other than glaucoma that might affect the measurements of IOP, assessment of visual function, visual field testing Proliferative diabetic retinopathy Previous intraocular surgery one or both eyes except laser PI more than 3 months ago and cataract extraction with PC IOL more than 4 months ago.

Undergone ophthalmic laser (other than laser PI > 3 months ago), refractive, conjunctival, or intraocular surgery in either eye; Would likely require cataract surgery within 6 months of randomization Current or expected use of corticosteroids

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Latanoprost
Latanoprost (0.005%) eye drops, once daily in the evening

Procedure:
• SLT
Selective Laser Trabeculoplasty

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra Ocular Pressure	To assess the mean and percentage reduction of Intra Ocular Pressure.	24 months	Yes
Secondary	Quality of life	To assess the visual function and quality of life	24 months	Yes