Base-in Prism Spectacles for Intermittent Exotropia

Completed · Not applicable

Conditions studied: Exotropia Intermittent

In brief

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

Key facts

Study ID

NCT03998670

Run by

Jaeb Center for Health Research

People needed

61

Starts

2019-09-01

Expected to finish

2020-07-30

Last updated by the study team

2023-10-04

Who can join

Age: 3 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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