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

• Sponsor: University of the Incarnate Word (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03352492
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 5.4

Study Details

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	Phase
Glaucoma, Angle-Closure	Procedure: Superior laser peripheral iridotomy; Procedure: Temporal laser peripheral iridotomy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Paired eyePaired eye
• Masking: Single (Participant)
• Masking Description: Subject is masked to which eye has the iridotomy at which location
• Primary Purpose: Supportive Care
• Official Title: Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function
• Actual Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in visual acuity [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 [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 [30 days post-operative]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of the Incarnate Word	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• University of the Incarnate Word

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Trevino, OD, FAAO, Associate Professor, University of the Incarnate Word
• ClinicalTrials.gov Identifier: NCT03352492
• Other Study ID Numbers: 16-02-003
• First Posted: Nov 24, 2017
• Last Update Posted: Apr 14, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma, Angle-Closure

Study Results

No Results Posted as of Apr 14, 2020