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

NCT01032603 | Completed Results DMC

• 2 other identifiers: NEI-1452U10EY011751
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IXT; Exotropia; Strabismus; Intermittent exotropia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Suboptimal Surgical Outcome as Assessed by Motor Alignment and Stereoacuity at Near by 3 Years

  A participant's intermittent exotropia (IXT) was considered to be a suboptimal surgical outcome if at any visit occurring 6 months or later, ANY of the following criteria are present by masked examiner testing: 1. Exotropia at distance OR near at any time during the exam (i.e., can be constant or intermittent; determined by a cover/uncover test) with a magnitude of ≥10Δ by SPCT, confirmed by a retest 2. Constant esotropia at distance OR near (determined by at least 3 cover/uncover tests-one must be before any dissociation) with a magnitude of ≥6Δ by SPCT, confirmed by a retest 3. Decrease in Randot Preschool near stereoacuity ≥2 octaves (≥0.6 log arcsec) from enrollment, or to nil, confirmed by a retest Participants who underwent reoperation (or treatment with botulinum toxin) without first meeting any of the above suboptimal surgical outcome criteria were also counted as suboptimal surgical outcomes in the primary analysis.

  3 years

Secondary Outcomes (25)

• Patients With Exotropia by 3 Years

  Enrollment to 3 years

• Patients With Constant Esotropia by 3 Years

  Enrollment to 3 years

• Number of Participants With Stereo Loss by 3 Years

  Enrollment to 3 years

• Number of Participants With Exotropia Control at Distance at 3 Years

  3 years after enrollment

• Mean Distance Control at 3 Years

  3 years after enrollment

Study Arms (2)

Bilateral lateral rectus recession

ACTIVE COMPARATOR

Bilateral lateral rectus recession surgery

Procedure: Bilateral lateral rectus recession (BLRc)

Unilateral lateral rectus recession

ACTIVE COMPARATOR

Unilateral lateral rectus recession w/ medial rectus resection surgery

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

Interventions

Bilateral lateral rectus recession (BLRc) PROCEDURE

Bilateral lateral rectus recession surgery

Also known as: BLR, BLRc

Bilateral lateral rectus recession

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

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.

Also known as: R&R

Unilateral lateral rectus recession

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 to \< 11 years
• Intermittent exotropia (manifest deviation) meeting all of the following:
• Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
• Largest exodeviation at either distance, near OR remote distance between 15 and 50 prism diopters (PD) (inclusive) by prism and alternate cover test (PACT)
• Exodeviation at least 15 PD at distance and near by PACT
• Basic type or pseudo divergence excess type
• Stereoacuity of 400 arcsec or better at near by Preschool Randot stereotest (better of 2 measures)
• Visual acuity in the worse eye at least 0.3 logMAR (20/40 on ATS HOTV or 70 letters on E-ETDRS)
• No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS testing)
• Absence of high AC/A ratio (exclude \> 6:1)
• No previous intraocular surgery, strabismus surgery, or botulinum toxin treatment
• Investigator planning to perform surgery for correction of IXT
• No hyperopia greater than +3.50 D spherical equivalent (SE) in either eye

You may not qualify if:

• Coexisting vertical deviation, oblique muscle dysfunction, dissociated vertical deviation (DVD), or A or V pattern, any of which the investigator plans to address with vertical transposition of horizontal rectus muscles, oblique surgery, or vertical rectus muscle surgery, i.e., only small vertical deviations, oblique muscle dysfunction, DVD, and A or V patterns not requiring surgery are allowed
• Limitation of ocular rotations due to restrictive or paretic strabismus
• Craniofacial malformations affecting the orbits
• Interocular visual acuity difference of more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to \< 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old) and/or investigator plans to initiate amblyopia treatment at this time.
• High AC/A ratio (exclude \> 6:1 by gradient method)
• Prior strabismus surgery or botulinum toxin injection
• Ocular disorders that would reduce visual acuity (except refractive error)
• Prior intraocular or refractive surgery
• Significant neurological impairment such as cerebral palsy. Patients with mild speech and/or learning disabilities are eligible.
• Investigator planning to change refractive correction at this time (if the patient is otherwise eligible, the investigator should consider prescribing refractive correction and bringing the patient back at a later time for enrollment).

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Pediatric Eye Disease Investigator Group: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232-8808, United States

Location

Related Publications (5)

• Repka MX, Chandler DL, Holmes JM, Donahue SP, Hoover DL, Mohney BG, Phillips PH, Stout AU, Ticho BH, Wallace DK; Pediatric Eye Disease Investigator Group. The Relationship of Age and Other Baseline Factors to Outcome of Initial Surgery for Intermittent Exotropia. Am J Ophthalmol. 2020 Apr;212:153-161. doi: 10.1016/j.ajo.2019.12.008. Epub 2019 Dec 17.

  PMID: 31862447 BACKGROUND

• Pediatric Eye Disease Investigator Group; Writing Committee; Donahue SP, Chandler DL, Holmes JM, Arthur BW, Paysse EA, Wallace DK, Petersen DB, Melia BM, Kraker RT, Miller AM. A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia. Ophthalmology. 2019 Feb;126(2):305-317. doi: 10.1016/j.ophtha.2018.08.034. Epub 2018 Sep 3.

  PMID: 30189281 RESULT

• Holmes JM, Hercinovic A, Melia BM, Leske DA, Hatt SR, Chandler DL, Dean TW, Kraker RT, Enyedi LB, Wallace DK, Donahue SP, Cotter SA; Pediatric Eye Disease Investigator Group. Improvement in health-related quality of life following strabismus surgery for children with intermittent exotropia. J AAPOS. 2021 Apr;25(2):82.e1-82.e7. doi: 10.1016/j.jaapos.2020.11.021. Epub 2021 Apr 24.

  PMID: 33905836 RESULT

• Donahue SP, Chandler DL, Wu R, Marsh JD, Law C, Areaux RG Jr, Ghasia FF, Li Z, Kraker RT, Cotter SA, Holmes JM; Pediatric Eye Disease Investigator Group. Eight-Year Outcomes of Bilateral Lateral Rectus Recessions versus Unilateral Recession-Resection in Childhood Basic-Type Intermittent Exotropia. Ophthalmology. 2024 Jan;131(1):98-106. doi: 10.1016/j.ophtha.2023.09.004. Epub 2023 Sep 9.

  PMID: 37696452 RESULT

• Pang Y, Gnanaraj L, Gayleard J, Han G, Hatt SR. Interventions for intermittent exotropia. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD003737. doi: 10.1002/14651858.CD003737.pub4.

  PMID: 34516656 DERIVED

Related Links

• PEDIG Public Website

MeSH Terms

Conditions

Exotropia; Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Results Point of Contact

• Title: Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
• Organization: Jaeb Center for Health Research

rkraker@jaeb.org

813-975-8690

Study Officials

• Sean P Donahue, M.D., Ph.D.

  Pediatric Ophthalmology Service, Vanderbilt Children's Hospital, Nashville, TN

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 15, 2009
• Study Start: June 1, 2010
• Primary Completion: February 9, 2017
• Study Completion: February 18, 2022
• Last Updated: February 7, 2024
• Results First Posted: May 7, 2019

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available after publication of each primary manuscript.
• Access Criteria: Users accessing the data must enter an email address.

Locations

US (1)