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Base-in Prism Spectacles for Intermittent Exotropia (IXT6)

Primary Purpose

Exotropia Intermittent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prism Glasses
Non-Prism Glasses
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exotropia Intermittent focused on measuring Prism

Eligibility Criteria

3 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB Pediatric Eye Care; Birmingham Health Care
  • Midwestern University Eye Institute
  • Arkansas Childrens
  • Southern California College of Optometry
  • Western University College of Optometry
  • Nova Southeastern University College of Optometry, The Eye Institute
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Illinois College of Optometry
  • University of Chicago
  • Indiana School of Optometry
  • Indiana University School of Optometry
  • Wolfe Eye Clinic
  • University of Kentucky Department of Neurology
  • Wilmer Eye Institute
  • Boston Medical Center
  • Boston Children's Hospital Waltham
  • Pediatric Ophthalmology, P.C.
  • University of Nebraska Medical Center
  • Cincinnati Children's Hospital
  • Ohio State University College of Optometry
  • OHSU Casey Eye Institute
  • Pediatric Ophthalmology of Erie
  • Salus University/Pennsylvania College of Optometry
  • Vanderbilt University Medical Center
  • Texas Children's Hospital - Dept. Of Ophthalmology
  • Houston Eye Associates
  • Virginia Pediatric Eye Center
  • Gundersen Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prism Group

Non-Prism Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Exotropia Control Score at Distance, % With Treatment Response
The secondary analysis will calculate the percentage of participants with a "treatment response," defined as ≥1 point improvement in control of their distance exodeviation (average of 3 measurements) between baseline and the 8-week outcome exam.
Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia
The proportion of participants with no spontaneous tropia at 8 weeks will be compared between treatment groups using a two-sided Barnard's test with alpha of 0.05, with calculation of a two-sided 95% confidence interval on the difference in proportions. No spontaneous tropia at the 8-week primary outcome exam is defined as a score of ≤2 (0, 1, or 2) on all three assessments of control at distance and at near.
Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks
Control of the exodeviation was measured at distance using the IXT Office Control Score, (Mohney, 2006) which ranges from 0 (phoria) to 5 (constant exotropia). Control levels 3-5 were assigned based on the duration of manifest exotropia during a 30-second period before any dissociation. If no exotropia was observed, control levels 0-2 were assigned based on the longest time to reestablishing fusion after 3 consecutive 10-second periods of dissociation. Control was measured at the beginning, middle, and end (3 tests) of a 20- to 40-minute office examination, and the mean was used. The change in distance control from baseline to 8 weeks will be calculated. A negative value indicates improvement.
Exotropia Control Score at Near, Continuous Score
Near control will be evaluated similarly to the primary outcome and outcome measures 2-4. Near control scores range from 0 to 5 with higher scores indicating a worse outcome.
Exodeviation by PACT at Distance, Continuous
The measure of ocular alignment at distance by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Exodeviation by PACT at Near, Continuous
The measure of ocular alignment at near by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Randot Preschool Stereoacuity at Near, Continuous
Randot® Preschool Stereoacuity test (Stereo Optical Co., Inc., Chicago, IL). For analysis, stereoacuity was converted from seconds of arc scores to log arcsec values (in parentheses) as follows: 40 (1.60), 60 (1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90); participants with no detectable (nil) stereoacuity were assigned the value of 1600 (3.20). The measure of Randot Preschool Stereoacuity at near will be summarized at 8 weeks for each treatment group. A lower score is better.
Compliance of Spectacle Wear
Parents will be asked to complete a compliance calendar by recording the percentage of time their child has worn the study-prescribed spectacle correction each day. Proportion of time worn each day will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%). Based on review of the calendars and discussion with parents at the 8-week outcome exam, the investigator will record the total proportion of time worn as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%: did not fill prescription or never picked up spectacles). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Child Assessment of Symptoms - Do Your Eyes Hurt?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Child Assessment of Symptoms - Do Your Eyes Feel Funny?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Child Assessment of Symptoms - Do You Have Double Vision?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Child Assessment of Symptoms - Is it Hard for You to Stare at Things?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Child Assessment of Symptoms - Do Your Eyes go in and Out?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Child Assessment of Symptoms - Is it Hard to Focus Your Eyes?
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.

Full Information

First Posted
June 24, 2019
Last Updated
September 27, 2023
Sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT03998670
Brief Title
Base-in Prism Spectacles for Intermittent Exotropia
Acronym
IXT6
Official Title
Intermittent Exotropia Study 6: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exotropia Intermittent
Keywords
Prism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prism Group
Arm Type
Experimental
Arm Description
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
Arm Title
Non-Prism Group
Arm Type
Placebo Comparator
Arm Description
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Intervention Type
Device
Intervention Name(s)
Prism Glasses
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Non-Prism Glasses
Intervention Description
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
Primary Outcome Measure Information:
Title
Exotropia Control Score at Distance, Continuous Score
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Exotropia Control Score at Distance, % With Treatment Response
Description
The secondary analysis will calculate the percentage of participants with a "treatment response," defined as ≥1 point improvement in control of their distance exodeviation (average of 3 measurements) between baseline and the 8-week outcome exam.
Time Frame
8 weeks
Title
Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia
Description
The proportion of participants with no spontaneous tropia at 8 weeks will be compared between treatment groups using a two-sided Barnard's test with alpha of 0.05, with calculation of a two-sided 95% confidence interval on the difference in proportions. No spontaneous tropia at the 8-week primary outcome exam is defined as a score of ≤2 (0, 1, or 2) on all three assessments of control at distance and at near.
Time Frame
8 Weeks
Title
Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks
Description
Control of the exodeviation was measured at distance using the IXT Office Control Score, (Mohney, 2006) which ranges from 0 (phoria) to 5 (constant exotropia). Control levels 3-5 were assigned based on the duration of manifest exotropia during a 30-second period before any dissociation. If no exotropia was observed, control levels 0-2 were assigned based on the longest time to reestablishing fusion after 3 consecutive 10-second periods of dissociation. Control was measured at the beginning, middle, and end (3 tests) of a 20- to 40-minute office examination, and the mean was used. The change in distance control from baseline to 8 weeks will be calculated. A negative value indicates improvement.
Time Frame
8 Weeks
Title
Exotropia Control Score at Near, Continuous Score
Description
Near control will be evaluated similarly to the primary outcome and outcome measures 2-4. Near control scores range from 0 to 5 with higher scores indicating a worse outcome.
Time Frame
8 Weeks
Title
Exodeviation by PACT at Distance, Continuous
Description
The measure of ocular alignment at distance by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Time Frame
8 Weeks
Title
Exodeviation by PACT at Near, Continuous
Description
The measure of ocular alignment at near by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Time Frame
8 Weeks
Title
Randot Preschool Stereoacuity at Near, Continuous
Description
Randot® Preschool Stereoacuity test (Stereo Optical Co., Inc., Chicago, IL). For analysis, stereoacuity was converted from seconds of arc scores to log arcsec values (in parentheses) as follows: 40 (1.60), 60 (1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90); participants with no detectable (nil) stereoacuity were assigned the value of 1600 (3.20). The measure of Randot Preschool Stereoacuity at near will be summarized at 8 weeks for each treatment group. A lower score is better.
Time Frame
8 Weeks
Title
Compliance of Spectacle Wear
Description
Parents will be asked to complete a compliance calendar by recording the percentage of time their child has worn the study-prescribed spectacle correction each day. Proportion of time worn each day will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%). Based on review of the calendars and discussion with parents at the 8-week outcome exam, the investigator will record the total proportion of time worn as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%: did not fill prescription or never picked up spectacles). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Time Frame
8 weeks
Title
Child Assessment of Symptoms - Do Your Eyes Hurt?
Description
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Child Assessment of Symptoms - Do Your Eyes Feel Funny?
Description
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Child Assessment of Symptoms - Do You Have Double Vision?
Description
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Child Assessment of Symptoms - Is it Hard for You to Stare at Things?
Description
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun?
Description
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Child Assessment of Symptoms - Do Your Eyes go in and Out?
Description
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Child Assessment of Symptoms - Is it Hard to Focus Your Eyes?
Description
Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Description
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Description
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Description
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Description
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Description
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Description
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Title
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Description
Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks.
Time Frame
8 Weeks
Other Pre-specified Outcome Measures:
Title
Distance Visual Acuity (Snellen Equivalent)
Description
Distance visual acuity will be assessed at the 8-week outcome exam. Any optotype method can be used for testing. The distribution of distance visual acuity Snellen Equivalents will be tabulated for each treatment group. A lower Snellen Equivalent is best.
Time Frame
8 Weeks
Title
Fusional Convergence - Continuous Break Point
Description
As an exploratory analysis, the distribution of fusional convergence amplitude (break point, blur point, and recovery) at 8 weeks will be summarized for each treatment group. Fusional amplitudes are a measure of how well a participant can converge their eyes using fusional vergence. It is measured by increasing base-out prism to the point that the participant is no longer able to control the deviation. The total amount of fusion is the magnitude of the base-out prism the participant was able to overcome plus the magnitude of the deviation. A higher number of prism diopters for break point is better than a lower number. A lower number for recovery point is better than a higher number.
Time Frame
8 Weeks
Title
Suppression
Description
The suppression assessment is a standardized method of assessing the depth of suppression experienced while the participant is tropic (NOT aligned). Scoring is reported on an ordinal scale from 0 (no suppression) to 3 (dense suppression). "Missing" refers to cases in which participants were unable to understand the test and/or gave unreliable responses. As an exploratory analysis, the distribution of suppression level (none, mild, moderate, severe, missing) will be tabulated after 8 weeks by treatment group.
Time Frame
8 Weeks
Title
Fusional Convergence - Continuous Recovery Point
Description
As an exploratory analysis, the distribution of fusional convergence amplitude (break point, blur point, and recovery) at 8 weeks will be summarized for each treatment group. Fusional amplitudes are a measure of how well a participant can converge their eyes using fusional vergence. It is measured by increasing base-out prism to the point that the participant is no longer able to control the deviation. The total amount of fusion is the magnitude of the base-out prism the participant was able to overcome plus the magnitude of the deviation. A higher number of prism diopters for break point is better than a lower number. A lower number for recovery is better than a higher number.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Morrison, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Allison I Summers, OD, MCR
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Pediatric Eye Care; Birmingham Health Care
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Midwestern University Eye Institute
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Arkansas Childrens
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831-1699
Country
United States
Facility Name
Western University College of Optometry
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States
Facility Name
Nova Southeastern University College of Optometry, The Eye Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33382
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Illinois College of Optometry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
University of Chicago
City
Hyde Park
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana School of Optometry
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Indiana University School of Optometry
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Kentucky Department of Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-9028
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Boston Children's Hospital Waltham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Facility Name
Pediatric Ophthalmology, P.C.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1280
Country
United States
Facility Name
OHSU Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pediatric Ophthalmology of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16501
Country
United States
Facility Name
Salus University/Pennsylvania College of Optometry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Children's Hospital - Dept. Of Ophthalmology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Eye Associates
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Virginia Pediatric Eye Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
IPD Sharing Time Frame
Data will be made available after publication.
IPD Sharing Access Criteria
Users accessing the data must enter an email address.
IPD Sharing URL
http://pedig.jaeb.org
Citations:
PubMed Identifier
37399233
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.
Results Reference
result
PubMed Identifier
34793970
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.
Results Reference
result
Links:
URL
https://public.jaeb.org/pedig
Description
PEDIG Public Website

Learn more about this trial

Base-in Prism Spectacles for Intermittent Exotropia

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