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: June 12, 2014
Last verified: June 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
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: 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: June 12, 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 October 19, 2014