Study Results
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View full resultsBasic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2019-09-01
2020-07-30
Brief Summary
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* Mean distance intermittent exotropia (IXT) control score (the mean of 3 control scores) (primary outcome)
* The proportion of participants demonstrating a "treatment response," defined as ≥1 point improvement in the mean distance IXT control score without spontaneous exotropia during control testing (secondary outcome)
* The proportion of participants reporting adverse effects and good/excellent spectacle wear compliance
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Prism Group
Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant
Prism Glasses
Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses
Non-Prism Group
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
Interventions
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Prism Glasses
Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses
Non-Prism Glasses
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
Eligibility Criteria
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Inclusion Criteria
* Age 3 to 13 years
* Mean distance control score of ≥2.00 points with at least 1 measure of 3, 4, or 5 points (i.e, spontaneous tropia) from the 3 assessments during the exam
* A near control score ≤4 on at least 1 of 3 assessments (cannot have score of 5, 5, 5)
* Distance exodeviation between 16 Prism Diopters (Δ) and 35 Δ (inclusive) by PACT
* Near exodeviation between 10 Δ and 35 Δ (inclusive) by PACT
* Near deviation does not exceed distance deviation by more than 10 Δ by PACT (i.e., convergence insufficiency-type IXT excluded)
* Refractive error between -6.00 Diopters (D) spherical equivalent (SE) and +2.50 D SE (inclusive) (based on a cycloplegic refraction performed within 7 months but prior to the day of enrollment)
* Refractive correction (must be worn for at least 1 week if refractive error meets any of the following (based on a cycloplegic refraction performed within 7 months but prior to the day of enrollment):
* SE anisometropia ≥1.00 D
* Astigmatism ≥1.00 D in either eye
* SE myopia ≥-0.50 D in either eye
* If spectacles have been prescribed and are worn, they must meet the following pre- enrollment criteria:
* SE anisometropia corrected to within 1.00 D of full SE anisometropic difference
* Astigmatism corrected to within 1.00 D of full magnitude; axis within 10 degrees if astigmatism ≤1.00 D and axis within 5 degrees if astigmatism \>1.00 D
Exclusion Criteria
* Vertical deviation \>3 Δ in primary gaze at distance or near
* Patterns (such as an "A" or "V" pattern) with a downgaze measurement of \>10 Δ difference from straight ahead by PACT, measured per investigator's routine method
* Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, orthoptics, patching, atropine, or other penalization
* Substantial overminus spectacles (spectacles overminused by more than 1.00 D SE than the most recent cycloplegic refraction and also results in minus SE power in the spectacles; underplussing is allowed) within the past 4 weeks
* Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
* Previous use of prism spectacles
Additional Eligibility Criteria for Randomization Based on Prism Adaptation Testing
* Exodeviation by PACT while wearing "trial" relieving prism for 30 minutes is smaller at distance or near than measured during initial testing (e.g. not fully adapting to prism at both distances)
* No new esotropia on cover test at near while wearing "trial" relieving prism for 30 minutes, compared with enrollment measurement taken without prism
* No esodeviation \>6 Δ on PACT at near while wearing "trial" relieving prism for 30 minutes
3 Years
13 Years
ALL
No
Sponsors
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Pediatric Eye Disease Investigator Group
NETWORK
National Eye Institute (NEI)
NIH
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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David G Morrison, MD
Role: STUDY_CHAIR
Vanderbilt University Medical Center
Allison I Summers, OD, MCR
Role: STUDY_CHAIR
Oregon Health and Science University
Locations
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UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States
Midwestern University Eye Institute
Glendale, Arizona, United States
Arkansas Childrens
Little Rock, Arkansas, United States
Southern California College of Optometry
Fullerton, California, United States
Western University College of Optometry
Pomona, California, United States
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Illinois College of Optometry
Chicago, Illinois, United States
University of Chicago
Hyde Park, Illinois, United States
Indiana School of Optometry
Bloomington, Indiana, United States
Indiana University School of Optometry
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
University of Kentucky Department of Neurology
Lexington, Kentucky, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Boston Children's Hospital Waltham
Boston, Massachusetts, United States
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Ohio State University College of Optometry
Columbus, Ohio, United States
OHSU Casey Eye Institute
Portland, Oregon, United States
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, United States
Houston Eye Associates
The Woodlands, Texas, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Countries
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References
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Summers AI, Morrison DG, Chandler DL, Henderson RJ, Chen AM, Leske DA, Walker KR, Li Z, Melia BM, Bitner DP, Kurup SP, Allen M, Phillips PH, Nash DL, Grigorian AP, Kraus CL, Miller AM, Titelbaum JR, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. A Pilot Randomized Clinical Trial of Base-in Relieving Prism Spectacle Treatment of Intermittent Exotropia. Optom Vis Sci. 2023 Jul 1;100(7):432-443. doi: 10.1097/OPX.0000000000002039. Epub 2023 Jul 1.
Hatt SR, Leske DA, Holmes JM, Henderson RJ, Chandler DL, Morrison DG, Summers AI, Cotter SA. Testing depth of suppression in childhood intermittent exotropia. J AAPOS. 2022 Feb;26(1):36-38.e1. doi: 10.1016/j.jaapos.2021.08.303. Epub 2021 Nov 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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PEDIG Public Website
Other Identifiers
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IXT6
Identifier Type: -
Identifier Source: org_study_id
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