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

Primary Purpose

Glaucoma

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Latanoprost

SLT

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Open Angle Glaucoma or Ocular hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Aravind Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

latanoprost 2-8˚ C

SLT

Arm Description

latanoprost(0.005%)stored at 2-8˚ C

Selective laser Trabeculoplasty

Outcomes

Primary Outcome Measures

Intra Ocular Pressure

To assess the mean and percentage reduction of Intra Ocular Pressure.

Secondary Outcome Measures

Quality of life

To assess the visual function and quality of life

Full Information

NCT ID

NCT01639807

First Posted

July 11, 2012

Last Updated

July 11, 2012

Sponsor

Aurolab

1. Study Identification

Unique Protocol Identification Number

NCT01639807

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aurolab

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Open Angle Glaucoma or Ocular hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

latanoprost 2-8˚ C

Arm Type

Active Comparator

Arm Description

latanoprost(0.005%)stored at 2-8˚ C

Arm Title

SLT

Arm Type

Experimental

Arm Description

Selective laser Trabeculoplasty

Intervention Type

Drug

Intervention Name(s)

Latanoprost

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

SLT

Intervention Description

Selective Laser Trabeculoplasty

Primary Outcome Measure Information:

Title

Intra Ocular Pressure

Description

To assess the mean and percentage reduction of Intra Ocular Pressure.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Quality of life

Description

To assess the visual function and quality of life

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GEORGE V PUTHURAN, M.B.B.S, M.S

Organizational Affiliation

Aravind Eye Hospital,Madurai.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aravind Eye Hospital

City

Madurai

State/Province

Tamil Nadu

ZIP/Postal Code

625 020

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

DR. GEORGE V PUTHURAN, M.B.B.S,M.S

Phone

+91 0452 4356100

Ext

118

george@aravind.org

First Name & Middle Initial & Last Name & Degree

M. Mohamed Hussian, M.Pharm

Phone

+91 0452 4356100

Ext

364

clinicalresearch@aravind.org

12. IPD Sharing Statement

Citations:

PubMed Identifier

35943114

Citation

Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

Results Reference

derived

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

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