Comparison of Superior vs Nasal/Temporal Laser Peripheral Iridotomy in Primary Angle Closure

Not Applicable

Completed

• Conditions: Glaucoma, Angle-Closure
• Interventions: Procedure: Laser peripheral iridotomy

• Registration Number: NCT03187821
• Lead Sponsor: Venkatesh Rengaraj

Brief Summary

The purpose of this study is to determine if location of laser peripheral iridotomy (LPI) that is the standard of care treatment for angle closure glaucoma is related to changes in post-operative intraocular pressure (IOP), endothelial cell count,anterior chamber angle morphology and onset of new visual disturbances.

Detailed Description

Study hypothesis: Location of laser peripheral iridotomy affects occurrence of post-operative dysphotopsia symptoms, intraocular pressure, anterior chamber angle morphology and corneal endothelial cell count Study design: Multicenter randomized, prospective, single masked trial Trial setting: Hospitals Trial type: Treatment

Interventions: South Indian subjects aged 30 years or greater, with primary angle closure suspect (PACS) or primary angle closure/ primary angle closure glaucoma(PAC/PACG) will be randomized to either bilateral superior or nasal/temporal laser peripheral iridotomy. Subjects will undergo noninvasive testing and imaging studies to measure IOP, anterior chamber angle morphology and endothelial cell count and asked to answer a questionnaire at baseline and again at 2 weeks and 6 months after treatment Primary outcome measures: Occurrence of new self-reported general eye or dysphotopsia symptoms.

Secondary outcome measures: intraocular pressure, anterior chamber and anterior chamber angle morphology, endothelial cell count.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-01
• Study Completion: 2015-01
• Study First Submitted: 2017-03-14
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-14
• Last Update Submitted: 2017-06-14
• Study First Posted: 2017-06-15
• Last Update Posted: 2017-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• diagnosis of PACS or PAC/PACG in at least one eye

Exclusion Criteria

• bilaterally pseudophakic
• prior iridotomy, iridoplasty, or incisional glaucoma surgery in either eye
• signs or symptoms consistent with acute angle closure at time of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal/temporal	Laser peripheral iridotomy	Laser peripheral iridotomy done at temporal/nasal part of iris.
Superior	Laser peripheral iridotomy	Laser peripheral iridotomy done at superior part of iris.

Primary Outcome Measures

Name	Time	Method
Occurrence of new self-reported general eye or dysphotopsia symptoms	6 Months	Questionnaire using a Likert scale

Secondary Outcome Measures

Name	Time	Method
Anterior chamber angle morphology	6 Months	measured in micrometers using anterior segment optical coherence tomography
Choroidal thickness	6 Months	measured in micrometers using enhanced depth optical coherence tomography
Intraocular pressure	6 Months	measured in mmHg
Corneal endothelial cell count	6 Months	measured on a continuous scale