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Bilateral Lateral Rectus Recession Versus Unilateral Recess-Resect for Intermittent Exotropia

NCT01032603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2024-02-07

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness of bilateral lateral rectus muscle recession versus unilateral lateral rectus recession with medial rectus resection procedures for the treatment of basic type and pseudo divergence excess type intermittent exotropia.

Conditions

  • Exotropia

Interventions

PROCEDURE

Bilateral lateral rectus recession (BLRc)

Bilateral lateral rectus recession surgery

PROCEDURE

Unilateral lateral rectus recession with medial rectus resection (R&R)

A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.

Sponsors & Collaborators

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Sean P Donahue, M.D., Ph.D. · Pediatric Ophthalmology Service, Vanderbilt Children's Hospital, Nashville, TN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-01
Primary Completion
2017-02-09
Completion
2022-02-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01032603 on ClinicalTrials.gov