Observation Versus Occlusion Therapy for Intermittent Exotropia (IXT2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT01032330
First received: December 11, 2009
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

The present study is being conducted to assess the natural history of intermittent exotropia and to establish the effectiveness of occlusion in its treatment.

Study Objectives:

  • To determine the effectiveness of occlusion for the treatment of intermittent exotropia among patients aged 3 to < 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest
  • To determine the natural history of intermittent exotropia among patients aged 3 to < 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest

Condition Intervention
Exotropia
Device: occlusion treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Observation Versus Occlusion Therapy for Intermittent Exotropia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Deterioration by 6 months as assessed by motor alignment and stereoacuity at near [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Deterioration by 3 years as assessed by motor alignment and stereoacuity at near [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • distance stereoacuity [ Time Frame: every 6 months for 3 years of follow-up ] [ Designated as safety issue: No ]
  • monofixation status [ Time Frame: every 6 months for 3 years of follow-up ] [ Designated as safety issue: No ]
  • development of amblyopia [ Time Frame: every 6 months for 3 years of follow-up ] [ Designated as safety issue: No ]
  • health related quality of life [ Time Frame: every 6 months for 3 years of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 336
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation
Patients randomized to the observation group will receive no treatment (other than refractive correction).
Active Comparator: Occlusion Therapy Device: occlusion treatment
Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
Other Names:
  • occlusion therapy
  • occlusion treatment
  • patching

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 12 months to < 11 years
  • Intermittent exotropia (manifest deviation) meeting all of the following criteria:

    • Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
    • Exodeviation at least 15PD at distance OR near measured by prism and alternate cover test (PACT)
    • Exodeviation at least 10PD at distance measured by PACT
  • No previous surgical or non-surgical treatment for IXT (other than refractive correction)
  • Visual acuity in the worse eye at least 0.3 logMAR (20/40 on ATS HOTV or 70 letters on E-ETDRS) for children ≥ 3 years of age
  • No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS) for children ≥ 3 years of age
  • No hyperopia greater than +3.50 D spherical equivalent in either eye
  • No myopia greater than -6.00 D spherical equivalent in either eye
  • No prior strabismus, intraocular, or refractive surgery
  • No abnormality of the cornea, lens, or central retina
  • Investigator willing to observe the IXT untreated for 3 years unless specific criteria for deterioration are met

Exclusion Criteria:

  • Pure phoria at both distance and near
  • Prior non-surgical treatment for IXT other than refractive correction (e.g., vergence therapy, occlusion, vision therapy/orthoptics, or deliberate over-minus with spectacles more than 0.50D)
  • Previous amblyopia treatment other than refractive correction within 1 year
  • Vision therapy/orthoptics for any reason within the last year
  • Interocular visual acuity difference 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) (patients ≥ 3 years only) and/or investigator plans to initiate amblyopia treatment at this time.
  • Limitation of ocular rotations due to restrictive or paretic strabismus
  • Craniofacial malformations affecting the orbits
  • Ocular disorders which would reduce visual acuity (except refractive error)
  • Prior strabismus surgery or botulinum injection, intraocular surgery, or refractive surgery
  • Strabismus surgery planned
  • Known skin reactions to patch or bandage adhesives
  • Significant neurological impairment such as cerebral palsy. Patients with mild speech delays or common reading and/or learning disabilities are not excluded.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032330

Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831-1699
United States, Minnesota
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Chair: Susan A Cotter, O.D., M.S. Southern California College of Optometry, Fullerton, CA
Study Chair: Brian G Mohney, M.D. Department of Ophthalmology, Mayo Clinic, Rochester, MN
  More Information

No publications provided

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01032330     History of Changes
Other Study ID Numbers: NEI-146, 2U10EY011751
Study First Received: December 11, 2009
Last Updated: March 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Jaeb Center for Health Research:
intermittent exotropia
IXT
natural history
occlusion therapy
occlusion
patching
strabismus
strabismus treatment
stereoacuity
motor alignment

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

ClinicalTrials.gov processed this record on April 16, 2014