Clinical trial NCT03998670: Base-in Prism Spectacles for Intermittent Exotropia
Official title: Intermittent Exotropia Study 6: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exotropia Intermittent
Keywords: Prism
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Pediatric Eye Disease Investigator Group
name: National Eye Institute (NEI)
First posted: 2019-06-26
Enrollment: 61
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Exotropia Control Score at Distance, Continuous Score
timeFrame: 8 weeks
Secondary outcomes:
measure: Exotropia Control Score at Distance, % With Treatment Response
timeFrame: 8 weeks
measure: Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia
timeFrame: 8 Weeks
measure: Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks
timeFrame: 8 Weeks
measure: Exotropia Control Score at Near, Continuous Score
timeFrame: 8 Weeks
measure: Exodeviation by PACT at Distance, Continuous
timeFrame: 8 Weeks
measure: Exodeviation by PACT at Near, Continuous
timeFrame: 8 Weeks
measure: Randot Preschool Stereoacuity at Near, Continuous
timeFrame: 8 Weeks
measure: Compliance of Spectacle Wear
timeFrame: 8 weeks
measure: Child Assessment of Symptoms - Do Your Eyes Hurt?
timeFrame: 8 Weeks
measure: Child Assessment of Symptoms - Do Your Eyes Feel Funny?
timeFrame: 8 Weeks
measure: Child Assessment of Symptoms - Do You Have Double Vision?
timeFrame: 8 Weeks
measure: Child Assessment of Symptoms - Is it Hard for You to Stare at Things?
timeFrame: 8 Weeks
measure: Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun?
timeFrame: 8 Weeks
measure: Child Assessment of Symptoms - Do Your Eyes go in and Out?
timeFrame: 8 Weeks
measure: Child Assessment of Symptoms - Is it Hard to Focus Your Eyes?
timeFrame: 8 Weeks
measure: Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
timeFrame: 8 Weeks
measure: Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
timeFrame: 8 Weeks
measure: Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
timeFrame: 8 Weeks
measure: Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
timeFrame: 8 Weeks
measure: Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
timeFrame: 8 Weeks
measure: Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
timeFrame: 8 Weeks
measure: Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
timeFrame: 8 Weeks
Other outcomes:
measure: Distance Visual Acuity (Snellen Equivalent)
timeFrame: 8 Weeks
measure: Fusional Convergence - Continuous Break Point
timeFrame: 8 Weeks
measure: Suppression
timeFrame: 8 Weeks
measure: Fusional Convergence - Continuous Recovery Point
timeFrame: 8 Weeks
Locations:
city: Birmingham
country: United States
facility: UAB Pediatric Eye Care; Birmingham Health Care
state: Alabama
city: Glendale
country: United States
facility: Midwestern University Eye Institute
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Childrens
state: Arkansas
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Pomona
country: United States
facility: Western University College of Optometry
state: California
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University College of Optometry, The Eye Institute
state: Florida
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Hyde Park
country: United States
facility: University of Chicago
state: Illinois
city: Bloomington
country: United States
facility: Indiana School of Optometry
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Optometry
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Department of Neurology
state: Kentucky
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital Waltham
state: Massachusetts
city: Grand Rapids
country: United States
facility: Pediatric Ophthalmology, P.C.
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University College of Optometry
state: Ohio
city: Portland
country: United States
facility: OHSU Casey Eye Institute
state: Oregon
city: Erie
country: United States
facility: Pediatric Ophthalmology of Erie
state: Pennsylvania
city: Philadelphia
country: United States
facility: Salus University/Pennsylvania College of Optometry
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital - Dept. Of Ophthalmology
state: Texas
city: The Woodlands
country: United States
facility: Houston Eye Associates
state: Texas
city: Norfolk
country: United States
facility: Virginia Pediatric Eye Center
state: Virginia
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
Study officials:
affiliation: Vanderbilt University Medical Center
name: David G Morrison, MD
role: STUDY_CHAIR
affiliation: Oregon Health and Science University
name: Allison I Summers, OD, MCR
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.