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

NCT ID: NCT01639807

Last Updated: 2012-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-12-31

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.

Conditions

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Glaucoma

Keywords

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Open Angle Glaucoma or Ocular hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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latanoprost 2-8˚ C

latanoprost(0.005%)stored at 2-8˚ C

Group Type ACTIVE_COMPARATOR

Latanoprost

Intervention Type DRUG

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

SLT

Selective laser Trabeculoplasty

Group Type EXPERIMENTAL

SLT

Intervention Type PROCEDURE

Selective Laser Trabeculoplasty

Interventions

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Latanoprost

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

Intervention Type DRUG

SLT

Selective Laser Trabeculoplasty

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurolab

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Aravind Eye Hospital,Madurai.

Locations

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Aravind Eye Hospital

Madurai, Tamil Nadu, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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

Role: primary

M. Mohamed Hussian, M.Pharm

Role: backup

References

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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.

Reference Type DERIVED
PMID: 35943114 (View on PubMed)

Other Identifiers

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AEH/SLT/012/2011

Identifier Type: -

Identifier Source: org_study_id