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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Latanoprost
* Procedure: SLT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: latanoprost 2-8˚ C<br>latanoprost(0.005%)stored at 2-8˚ C | Drug: Latanoprost<br>* Latanoprost (0.005%) eye drops, once daily in the evening<br>|
| Experimental: SLT<br>Selective laser Trabeculoplasty | Procedure: SLT<br>* Selective Laser Trabeculoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Ocular Pressure | To assess the mean and percentage reduction of Intra Ocular Pressure. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | To assess the visual function and quality of life | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Angle Glaucoma or Ocular hypertension