A Trial to study the effects of two drugs travoprost & brimonidine/timolol combination in patients with kanchbind (high pressure in eyes).

Phase 4

Completed

• Conditions: glaucoma

• Registration Number: CTRI/2011/11/002105

Brief Summary

•Glaucoma--------Second leading cause of blindness, silent thief of sight.

•   Progressive optic neuropathy with degeneration of

retinal ganglion cells.

•   Irreversible blindness if left undiagnosed & untreated

•   Normal IOP ® 10-20mm Hg.

•

Data from the Early Manifest Glaucoma Trial (EMGT) have shown that an additional 1 mm Hg of IOP lowering reduces the risk of glaucoma progression by 10 %.•At the baseline visit, patients will be randomized into 2 groups after investigations and diagnosis•12.3% of total blindness

•

•Vision loss range from 5.2 to 6.7 million

•

•Prevalence-1% to 4% in people over 40yrs in Asia

•

•¯ in IOP delays damage to optic nerve & visual field

•

•¯ in IOP by 30% ¯ disease progression from ~35 to 10%   .

Travoprost is will be given to one group

& Brimonidine + timolol  to another group

• Follow-up to be done - at 2, 4, 12 wks.

•IOP measurement & fundus examination will be done at every visit.

•Perimetery will be repeated  monthly.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-11
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

IOP in each eye more than 21 mm Hg. Best corrected visual acuity 6/18 or better in each eye.

Exclusion Criteria

• Progressive or functionally significant visual fields loss within past year.
• Pregnant women or lactating mothers.
• Patients with corneal abnormalities or any other conditions that prevent applanation tonometry.
• Patients with ocular infection, advanced cataract, ocular inflammation.
• Patients of bronchial asthma & cardiac disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perimetry	4, 8, 12 wks
Visual acuity	4, 8, 12 wks
IOP	4, 8, 12 wks
Slit lamp Bimicroscopy for optic disc evaluation	4, 8, 12 wks
Gonioscopy	4, 8, 12 wks

Secondary Outcome Measures

Name	Time	Method
Visual acuity	IOP

Trial Locations

Locations (1)

at ophthalmology dept. of PCMS & RC Bhopal.; 🇮🇳 Bhopal, MADHYA PRADESH, India

at ophthalmology dept. of PCMS & RC Bhopal.

🇮🇳Bhopal, MADHYA PRADESH, India

Dr Rekha mehani

Principal investigator

9827539825

drrekhasanjay@gmail.com