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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma, Angle-Closure

Intervention / Treatment
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* Procedure: Laser peripheral iridotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Superior<br>Laser peripheral iridotomy done at superior part of iris. | Procedure: Laser peripheral iridotomy<br>* location of laser peripheral iridotomy<br>|
| Active Comparator: Nasal/temporal<br>Laser peripheral iridotomy done at temporal/nasal part of iris. | Procedure: Laser peripheral iridotomy<br>* location of laser peripheral iridotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of new self-reported general eye or dysphotopsia symptoms | Questionnaire using a Likert scale | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | measured in mmHg | 6 Months | 
| Anterior chamber angle morphology | measured in micrometers using anterior segment optical coherence tomography | 6 Months | 
| Corneal endothelial cell count | measured on a continuous scale | 6 Months | 
| Choroidal thickness | measured in micrometers using enhanced depth optical coherence tomography | 6 Months |