Observation Versus Occlusion Therapy for Intermittent Exotropia

NCT01032330 | Completed Results DMC

• 2 other identifiers: NEI-1462U10EY011751
• Study Type: interventional
• Target: 611
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Exotropia

Keywords

intermittent exotropia; IXT; natural history; occlusion therapy; occlusion; patching; strabismus; strabismus treatment; stereoacuity; motor alignment

Outcome Measures

Primary Outcomes (4)

• Deterioration by 6 Months - Older Cohort

  The primary outcome measure for this study was whether the participant's condition had deteriorated within 6 months after randomization. Deterioration was defined as meeting one or both of the following criteria during a masked examination at either the 3-month or 6-month visit: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.

  6 months

• Deterioration by 3 Years - Older Cohort

  The primary outcome measure for this study was whether the participant's condition had deteriorated within 3 years after randomization. Deterioration was defined as meeting one or both of the following criteria during any masked examination between 3 months and 3 years after randomization: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.

  3 years

• Deterioration by 6 Months - Younger Cohort

  The primary outcome measure was deterioration of the intermittent exotropia (IXT) within 6 months after randomization. Motor deterioration was defined as a constant exotropia of 10 D or more at distance and near by SPCT, confirmed by a retest, at either the 3- or 6-month visit.

  6 months

• Deterioration by 3 Years - Younger Cohort

  The primary outcome measure was deterioration of the intermittent exotropia (IXT) within 6 months after randomization. Motor deterioration was defined as a constant exotropia of 10 D or more at distance and near by SPCT, confirmed by a retest, during any masked examination between 3 months and 3 years after randomization.

  3 years

Secondary Outcomes (11)

• Distance Stereoacuity - 3 Years

  Between baseline and 3 years

• Near Stereoacuity - 6 Months

  6 months

• Near Stereoacuity - 3 Years

  between baseline and 3 years

• Exotropia Control at Distance - 6 Months

  6 months

• Exotropia Control at Distance - 3 Years

  3 years

Study Arms (2)

Observation

NO INTERVENTION

Patients randomized to the observation group will receive no treatment (other than refractive correction).

Occlusion Therapy

ACTIVE COMPARATOR

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.

Device: occlusion treatment

Interventions

occlusion treatment DEVICE

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.

Also known as: occlusion therapy, patching

Occlusion Therapy

Eligibility Criteria

• Age: 12 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (2)

Southern California College of Optometry

Fullerton, California, 92831-1699, United States

Location

Mayo Clinic Department of Ophthalmology

Rochester, Minnesota, 55905, United States

Location

Related Publications (6)

• Pediatric Eye Disease Investigator Group; Cotter SA, Mohney BG, Chandler DL, Holmes JM, Repka MX, Melia M, Wallace DK, Beck RW, Birch EE, Kraker RT, Tamkins SM, Miller AM, Sala NA, Glaser SR. A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. Ophthalmology. 2014 Dec;121(12):2299-310. doi: 10.1016/j.ophtha.2014.07.021. Epub 2014 Sep 16.

  PMID: 25234012 RESULT

• Pediatric Eye Disease Investigator Group; Mohney BG, Cotter SA, Chandler DL, Holmes JM, Chen AM, Melia M, Donahue SP, Wallace DK, Kraker RT, Christian ML, Suh DW. A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age. Ophthalmology. 2015 Aug;122(8):1718-25. doi: 10.1016/j.ophtha.2015.04.025. Epub 2015 Jun 11.

  PMID: 26072346 RESULT

• Pediatric Eye Disease Investigator Group; Writing Committee; Mohney BG, Cotter SA, Chandler DL, Holmes JM, Wallace DK, Yamada T, Petersen DB, Kraker RT, Morse CL, Melia BM, Wu R. Three-Year Observation of Children 3 to 10 Years of Age with Untreated Intermittent Exotropia. Ophthalmology. 2019 Sep;126(9):1249-1260. doi: 10.1016/j.ophtha.2019.01.015. Epub 2019 Jan 26.

  PMID: 30690128 RESULT

• Cotter SA, Mohney BG, Chandler DL, Holmes JM, Wallace DK, Melia BM, Wu R, Kraker RT, Superstein R, Crouch ER, Paysse EA; Pediatric Eye Disease Investigator Group. Three-year observation of children 12 to 35 months old with untreated intermittent exotropia. Ophthalmic Physiol Opt. 2020 Mar;40(2):202-215. doi: 10.1111/opo.12668.

  PMID: 32202318 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

• Holmes JM, Hercinovic A, Melia BM, Leske DA, Hatt SR, Chandler DL, Dean TW, Kraker RT, Enyedi LB, Wallace DK, Mohney BG, Cotter SA; Pediatric Eye Disease Investigator Group. Health-related quality of life in children with untreated intermittent exotropia and their parents. J AAPOS. 2021 Apr;25(2):80.e1-80.e4. doi: 10.1016/j.jaapos.2020.10.011. Epub 2021 Mar 8.

  PMID: 33705917 DERIVED

Related Links

• PubMed Abstract - Older Cohort
• PubMed Central HHS Public Access - Full Text - Older Cohort
• PubMed Abstract - Younger Cohort

MeSH Terms

Conditions

Exotropia; Bites and Stings; Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

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

• 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

  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: January 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 19, 2020
• Results First Posted: May 8, 2019

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data from the 6-month study is entered. The data for the 3-year study will be made available in 2020.
• Access Criteria: Users will need a valid email address

Locations

US (2)