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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01639807

Enrollment

600

Registered

2012-07-13

Start date

2011-10-31

Completion date

2014-12-31

Last updated

2012-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Open Angle Glaucoma or Ocular hypertension

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.

Interventions

DRUGLatanoprost

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

PROCEDURESLT

Selective Laser Trabeculoplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intra Ocular Pressure	24 months	To assess the mean and percentage reduction of Intra Ocular Pressure.

Secondary

Measure	Time frame	Description
Quality of life	24 months	To assess the visual function and quality of life

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026