Back to results

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

Primary Purpose

Glaucoma, Angle-Closure

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Superior laser peripheral iridotomy

Temporal laser peripheral iridotomy

About this trial

This is an interventional supportive care trial for Glaucoma, Angle-Closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of the Incarnate WordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Bilateral iridotomy: Superior

Bilateral iridotomy: Temporal

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in visual acuity

Change from baseline best corrected visual acuity evaluated in number of letters correctly read on the ETDRS chart

Secondary Outcome Measures

Change in Peli-Robson contrast sensitivity

Change from baseline in contrast sensitivity evaluated in number of letters correctly read on the Peli-Robson chart

Change in CSV-1000 contrast sensitivity

Change from baseline in contrast sensitivity evaluated using the number of correct responses on the CSV-1000 test

Full Information

NCT ID

NCT03352492

First Posted

November 20, 2017

Last Updated

April 12, 2020

Sponsor

University of the Incarnate Word

1. Study Identification

Unique Protocol Identification Number

NCT03352492

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

February 2021 (Anticipated)

Study Completion Date

February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of the Incarnate Word

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Angle-Closure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Paired eye

Masking

Participant

Masking Description

Subject is masked to which eye has the iridotomy at which location

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bilateral iridotomy: Superior

Arm Type

Experimental

Arm Description

Arm Title

Bilateral iridotomy: Temporal

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Superior laser peripheral iridotomy

Intervention Description

Iridotomy placement between 11:00 and 1:00 o'clock

Intervention Type

Procedure

Intervention Name(s)

Temporal laser peripheral iridotomy

Intervention Description

Iridotomy placement at 3:00 or 9:00 o'clock

Primary Outcome Measure Information:

Title

Change in visual acuity

Description

Change from baseline best corrected visual acuity evaluated in number of letters correctly read on the ETDRS chart

Time Frame

30 days post-operative

Secondary Outcome Measure Information:

Title

Change in Peli-Robson contrast sensitivity

Description

Change from baseline in contrast sensitivity evaluated in number of letters correctly read on the Peli-Robson chart

Time Frame

30 days post-operative

Title

Change in CSV-1000 contrast sensitivity

Description

Change from baseline in contrast sensitivity evaluated using the number of correct responses on the CSV-1000 test

Time Frame

30 days post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ana Hagendorf, PhD

Phone

210-805-3036

wandless@uiwtx.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Trevino, OD

Organizational Affiliation

University of the Incarnate Word

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of the Incarnate Word

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana C Hagendorf, PhD

Phone

210-805-3036

wandless@uiwtx.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs