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

Not Applicable

• Conditions: Glaucoma
• Interventions: Drug: Latanoprost; Procedure: SLT

• Registration Number: NCT01639807
• Lead Sponsor: Aurolab

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Status Verified: 2012-07
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-11
• Last Update Submitted: 2012-07-11
• Study First Posted: 2012-07-13
• Last Update Posted: 2012-07-13
• Primary Completion: 2013-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
latanoprost 2-8˚ C	Latanoprost	latanoprost(0.005%)stored at 2-8˚ C
SLT	SLT	Selective laser Trabeculoplasty

Primary Outcome Measures

Name	Time	Method
Intra Ocular Pressure	24 months	To assess the mean and percentage reduction of Intra Ocular Pressure.

Secondary Outcome Measures

Name	Time	Method
Quality of life	24 months	To assess the visual function and quality of life

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamil Nadu, India