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

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ClinicalTrials.gov Identifier: NCT03352492
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.

Condition or disease Intervention/treatment
Glaucoma, Angle-Closure Procedure: Superior laser peripheral iridotomy Procedure: Temporal laser peripheral iridotomy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function
Actual Study Start Date : February 16, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bilateral iridotomy
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 Procedure: Temporal laser peripheral iridotomy


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352492


Contacts
Contact: Ana Hagendorf, PhD 210-805-3036 wandless@uiwtx.edu

Locations
United States, Texas
University of the Incarnate Word Recruiting
San Antonio, Texas, United States, 78209
Contact: Ana C Hagendorf, PhD    210-805-3036    wandless@uiwtx.edu   
Sponsors and Collaborators
University of the Incarnate Word
Investigators
Principal Investigator: Richard Trevino, OD University of the Incarnate Word
More Information

Responsible Party: Richard Trevino, OD, FAAO, Associate Professor, University of the Incarnate Word
ClinicalTrials.gov Identifier: NCT03352492     History of Changes
Other Study ID Numbers: 16-02-003
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Glaucoma, Angle-Closure
Glaucoma
Ocular Hypertension
Eye Diseases