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OpenTrials
Completed

NCT Number: NCT03187821

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

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.

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Key information

Conditions

Glaucoma, Angle-Closure Eye Diseases Glaucoma Ocular Hypertension

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser peripheral iridotomy

Procedure

location of laser peripheral iridotomy

Primary outcomes

  1. Occurrence of new self-reported general eye or dysphotopsia symptoms

    Time frame: 6 Months

    Questionnaire using a Likert scale

Secondary outcomes

  1. Intraocular pressure

    Time frame: 6 Months

    measured in mmHg

  2. Anterior chamber angle morphology

    Time frame: 6 Months

    measured in micrometers using anterior segment optical coherence tomography

  3. Corneal endothelial cell count

    Time frame: 6 Months

    measured on a continuous scale

  4. Choroidal thickness

    Time frame: 6 Months

    measured in micrometers using enhanced depth optical coherence tomography

Sponsors and collaborators

Lead sponsor

Venkatesh Rengaraj

Other

Collaborators

  • Johns Hopkins University

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jun 15, 2017
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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