Base-in Prism Spectacles for Intermittent Exotropia

NCT03998670 | Completed Results DMC

• 2 other identifiers: IXT62UG1EY011751
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 28

Brief Summary

The objective of this short-term, pilot randomized trial comparing spectacles with relieving prism to spectacles without prism is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to prism by comparing treatment groups on the following outcomes:

• 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

Conditions

Exotropia Intermittent

Keywords

Prism

Outcome Measures

Primary Outcomes (1)

• Exotropia Control Score at Distance, Continuous Score

  The primary analysis will be an intent-to-treat comparison of mean 8-week control of the distance exodeviation (average of 3 measurements) between treatment groups using an analysis of covariance (ANCOVA) model, which adjusts for baseline distance control. Distance control scores range from 0 to 5 with higher scores indicating a worse outcome.

  8 weeks

Secondary Outcomes (22)

• Exotropia Control Score at Distance, % With Treatment Response

  8 weeks

• Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia

  8 Weeks

• Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks

  8 Weeks

• Exotropia Control Score at Near, Continuous Score

  8 Weeks

• Exodeviation by PACT at Distance, Continuous

  8 Weeks

Other Outcomes (4)

• Distance Visual Acuity (Snellen Equivalent)

  8 Weeks

• Fusional Convergence - Continuous Break Point

  8 Weeks

• Suppression

  8 Weeks

Study Arms (2)

Prism Group

EXPERIMENTAL

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

Device: Prism Glasses

Non-Prism Group

PLACEBO COMPARATOR

Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant

Device: Non-Prism Glasses

Interventions

Prism Glasses DEVICE

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

Prism Group

Non-Prism Glasses DEVICE

Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism

Non-Prism Group

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Intermittent Exotropia meeting all of the following 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

You may not qualify if:

• Dissociated vertical deviation (DVD)
• 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

Sponsors & Collaborators

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

Study Sites (28)

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama, 35294, United States

Location

Midwestern University Eye Institute

Glendale, Arizona, 85308, United States

Location

Arkansas Childrens

Little Rock, Arkansas, 72202, United States

Location

Southern California College of Optometry

Fullerton, California, 92831-1699, United States

Location

Western University College of Optometry

Pomona, California, 91766, United States

Location

Nova Southeastern University College of Optometry, The Eye Institute

Fort Lauderdale, Florida, 33382, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

University of Chicago

Hyde Park, Illinois, 60637, United States

Location

Indiana School of Optometry

Bloomington, Indiana, 47405, United States

Location

Indiana University School of Optometry

Indianapolis, Indiana, 47405, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

University of Kentucky Department of Neurology

Lexington, Kentucky, 40536, United States

Location

Wilmer Eye Institute

Baltimore, Maryland, 21287-9028, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston Children's Hospital Waltham

Boston, Massachusetts, 02453, United States

Location

Pediatric Ophthalmology, P.C.

Grand Rapids, Michigan, 49546, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68114, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Ohio State University College of Optometry

Columbus, Ohio, 43210-1280, United States

Location

OHSU Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, 16501, United States

Location

Salus University/Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Children's Hospital - Dept. Of Ophthalmology

Houston, Texas, 77030, United States

Location

Houston Eye Associates

The Woodlands, Texas, 77381, United States

Location

Virginia Pediatric Eye Center

Norfolk, Virginia, 23502, United States

Location

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (2)

• 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.

  PMID: 37399233 RESULT

• 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.

  PMID: 34793970 RESULT

Related Links

• PEDIG Public Website

Results Point of Contact

• Title: Raymond Kraker, PEDIG Coordinating Center Director
• Organization: PEDIG Coordinating Center, Jaeb Center for Health Research

rkraker@jaeb.org

813 975 8690

Study Officials

• David G Morrison, MD

  Vanderbilt University Medical Center

  STUDY CHAIR

• Allison I Summers, OD, MCR

  Oregon Health and Science University

  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
• Masking Details: At the 8-week outcome visit, a Masked Examiner, who is a pediatric ophthalmologist, pediatric optometrist, or certified orthoptist, will assess the control of the exodeviation and perform PACT testing. The Masked Examiner must be someone other than the investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: September 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: October 4, 2023
• Results First Posted: October 17, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after publication.
• Access Criteria: Users accessing the data must enter an email address.

Locations

US (28)