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

NCT ID: NCT03352492

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-02-28

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma, Angle-Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Paired eye
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Superior laser peripheral iridotomy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Temporal laser peripheral iridotomy

Intervention Type PROCEDURE

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

Interventions

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Superior laser peripheral iridotomy

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

Intervention Type PROCEDURE

Temporal laser peripheral iridotomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Incarnate Word

OTHER

Sponsor Role lead

Responsible Party

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Richard Trevino, OD, FAAO

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Trevino, OD

Role: PRINCIPAL_INVESTIGATOR

University of the Incarnate Word

Locations

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University of the Incarnate Word

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ana Hagendorf, PhD

Role: CONTACT

210-805-3036

Facility Contacts

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Ana C Hagendorf, PhD

Role: primary

210-805-3036

Other Identifiers

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16-02-003

Identifier Type: -

Identifier Source: org_study_id

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