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

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ClinicalTrials.gov Identifier: NCT01032603
Recruitment Status : Active, not recruiting
First Posted : December 15, 2009
Last Update Posted : April 12, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

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

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2010
Primary Completion Date : February 9, 2017
Estimated Study Completion Date : February 2022


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 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

Exclusion Criteria:

  • 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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
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