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Clinical Trials/NCT03352492
NCT03352492UnknownNot Applicable

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

University of the Incarnate Word1 site in 1 country200 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
Change in visual acuity

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Bilateral iridotomy: Superior

Experimental

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: Superior laser peripheral iridotomy (Procedure)

Bilateral iridotomy: Temporal

Experimental

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: Temporal laser peripheral iridotomy (Procedure)

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Peli-Robson contrast sensitivity(30 days post-operative)
  • Change in CSV-1000 contrast sensitivity(30 days post-operative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Richard Trevino, OD, FAAO

Associate Professor

University of the Incarnate Word

Study Sites (1)

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