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Bilateral Lateral Rectus Recession Versus Unilateral Recess-Resect for Intermittent Exotropia (IXT1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT01032603
First received: December 11, 2009
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Exotropia
Procedure: Bilateral lateral rectus recession (BLRrec)
Procedure: Unilateral lateral rectus recession with medial rectus resection (R&R)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized Trial of Bilateral Lateral Rectus Recession Versus Unilateral Lateral Rectus Recession With Medial Rectus Resection for Intermittent Exotropia

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • surgical failure as assessed by motor alignment and stereoacuity at near [ Time Frame: 3 years ]
  • Proportion of Patients with Exotropia at 8 Years [ Time Frame: 8 years after enrollment ]
  • Distance Control at 8 Years [ Time Frame: 8 years after enrollment ]

Secondary Outcome Measures:
  • distance stereoacuity [ Time Frame: every 6 months for 3 years of follow-up ]
  • monofixation status [ Time Frame: every 6 months for 3 years of follow-up ]
  • development of amblyopia [ Time Frame: every 6 months for 3 years of follow-up ]
  • health related quality of life [ Time Frame: every 6 months for 3 years of follow-up ]
  • Distance PACT at 8 years [ Time Frame: 8 years after enrollment ]
  • Proportion of Patients with Consecutive Esotropia at 8 Years [ Time Frame: 8 years after enrollment ]
  • Near stereoacuity at 8 Years [ Time Frame: 8 years after enrollment ]
  • Cumulative Proportion of Patients with Reoperation by 8 Years [ Time Frame: 8 years after enrollment ]
  • Comparison of Number of Surgeries by 8 Years [ Time Frame: 8 years after enrollment ]

Estimated Enrollment: 336
Study Start Date: June 2010
Estimated Study Completion Date: February 2022
Primary Completion Date: February 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bilateral lateral rectus recession Procedure: Bilateral lateral rectus recession (BLRrec)
Bilateral lateral rectus recession surgery
Other Names:
  • BLR
  • BLRrec
Active Comparator: Unilateral lateral rectus recession w/ medial rectus resection 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.
Other Name: R&R

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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

Exclusion Criteria:

  • Coexisting vertical deviation, oblique muscle dysfunction, 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032603

Locations
United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-8808
Sponsors and Collaborators
Jaeb Center for Health Research
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Investigators
Study Chair: Sean P Donahue, M.D., Ph.D. Pediatric Ophthalmology Service, Vanderbilt Children's Hospital, Nashville, TN
  More Information

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01032603     History of Changes
Other Study ID Numbers: NEI-145
2U10EY011751 ( US NIH Grant/Contract Award Number )
Study First Received: December 11, 2009
Last Updated: March 6, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.

Keywords provided by Jaeb Center for Health Research:
IXT
Exotropia
Strabismus
Intermittent exotropia

Additional relevant MeSH terms:
Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on March 22, 2017