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

A

Aurolab

Status

Unknown

Conditions

Glaucoma

Treatments

Procedure: SLT
Drug: Latanoprost

Study type

Interventional

Funder types

Other

Identifiers

NCT01639807
AEH/SLT/012/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

600 participants in 2 patient groups

latanoprost 2-8˚ C
Active Comparator group
Description:
latanoprost(0.005%)stored at 2-8˚ C
Treatment:
Drug: Latanoprost
SLT
Experimental group
Description:
Selective laser Trabeculoplasty
Treatment:
Procedure: SLT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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