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

June 14, 2017 updated by: Venkatesh Rengaraj
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Superior
Laser peripheral iridotomy done at superior part of iris.
Procedure: Laser peripheral iridotomy
location of laser peripheral iridotomy
ACTIVE_COMPARATOR: Nasal/temporal
Laser peripheral iridotomy done at temporal/nasal part of iris.
Procedure: Laser peripheral iridotomy
location of laser peripheral iridotomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Venkatesh Rengaraj

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Rengaraj Venkatesh, DNB, Aravind Eye Hospital, Pondicherry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (ACTUAL)

June 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iface2pi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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