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

NCT01639807 | Unknown

• 1 other identifier: AEH/SLT/012/2011
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Open Angle Glaucoma or Ocular hypertension

Outcome Measures

Primary Outcomes (1)

• Intra Ocular Pressure

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

  24 months

Secondary Outcomes (1)

• Quality of life

  24 months

Study Arms (2)

latanoprost 2-8˚ C

ACTIVE COMPARATOR

latanoprost(0.005%)stored at 2-8˚ C

Drug: Latanoprost

SLT

EXPERIMENTAL

Selective laser Trabeculoplasty

Procedure: SLT

Interventions

Latanoprost DRUG

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

latanoprost 2-8˚ C

SLT PROCEDURE

Selective Laser Trabeculoplasty

SLT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurolab: lead

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 35943114 DERIVED

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• GEORGE V PUTHURAN, M.B.B.S, M.S

  Aravind Eye Hospital,Madurai.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

IN (1)