Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function

April 12, 2020 updated by: Richard Trevino, OD, FAAO, University of the Incarnate Word
To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • University of the Incarnate Word

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Angle-closure glaucoma
  • Angle-closure glaucoma suspect

Exclusion Criteria:

  • Monocular status
  • Previous intraocular surgery
  • Visual acuity worse than 20/40
  • Prior episode of acute angle-closure glaucoma
  • Pregnancy

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral iridotomy: Superior
Each subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye.
Procedure: Superior laser peripheral iridotomy
Iridotomy placement between 11:00 and 1:00 o'clock
Experimental: Bilateral iridotomy: Temporal
Each subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye.
Procedure: Temporal laser peripheral iridotomy
Iridotomy placement at 3:00 or 9:00 o'clock

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity
Time Frame: 30 days post-operative
Change from baseline best corrected visual acuity evaluated in number of letters correctly read on the ETDRS chart
30 days post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peli-Robson contrast sensitivity
Time Frame: 30 days post-operative
Change from baseline in contrast sensitivity evaluated in number of letters correctly read on the Peli-Robson chart
30 days post-operative
Change in CSV-1000 contrast sensitivity
Time Frame: 30 days post-operative
Change from baseline in contrast sensitivity evaluated using the number of correct responses on the CSV-1000 test
30 days post-operative

Collaborators and Investigators

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

Sponsor

University of the Incarnate Word

Investigators

  • Principal Investigator: Richard Trevino, OD, University of the Incarnate Word

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 (Actual)

January 1, 2018

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-02-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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