Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function
1 other identifier
interventional
200
1 country
1
Brief Summary
To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 24, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedApril 14, 2020
April 1, 2020
3.1 years
November 20, 2017
April 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in visual acuity
Change from baseline best corrected visual acuity evaluated in number of letters correctly read on the ETDRS chart
30 days post-operative
Secondary Outcomes (2)
Change in Peli-Robson contrast sensitivity
30 days post-operative
Change in CSV-1000 contrast sensitivity
30 days post-operative
Study Arms (2)
Bilateral iridotomy: Superior
EXPERIMENTALEach 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.
Bilateral iridotomy: Temporal
EXPERIMENTALEach 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.
Interventions
Iridotomy placement between 11:00 and 1:00 o'clock
Iridotomy placement at 3:00 or 9:00 o'clock
Eligibility Criteria
You may qualify if:
- Angle-closure glaucoma
- Angle-closure glaucoma suspect
You may not qualify if:
- Monocular status
- Previous intraocular surgery
- Visual acuity worse than 20/40
- Prior episode of acute angle-closure glaucoma
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of the Incarnate Word
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Trevino, OD
University of the Incarnate Word
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Subject is masked to which eye has the iridotomy at which location
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 20, 2017
First Posted
November 24, 2017
Study Start
January 1, 2018
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
April 14, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share