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
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma, Angle-Closure
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
Sites / Locations
- University of the Incarnate WordRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Arm Title
Bilateral iridotomy: Temporal
Arm Type
Experimental
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.
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
No
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
Email
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
Email
wandless@uiwtx.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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