Exotropia IntermittentIXT6NCT03998670
Base-in Prism Spectacles for Intermittent Exotropia
A study testing Prism Glasses and Non-Prism Glasses in people with Exotropia Intermittent, run by Jaeb Center for Health Research at 28 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Exotropia Intermittent
- What is being tested?
- Prism Glasses and Non-Prism Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 28 sitesUnited States
- Study dates
- 1 Sep 2019to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Wilmer Eye Institute
Baltimore, Maryland, 21287-9028
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, 35294
Indiana School of Optometry
Bloomington, Indiana, 47405
Boston Medical Center
Boston, Massachusetts, 02118
Boston Children's Hospital Waltham
Boston, Massachusetts, 02453
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Illinois College of Optometry
Chicago, Illinois, 60616
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Ohio State University College of Optometry
Columbus, Ohio, 43210-1280
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, 33382
Southern California College of Optometry
Fullerton, California, 92831-1699
Midwestern University Eye Institute
Glendale, Arizona, 85308
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, 49546
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, 77030
University of Chicago
Hyde Park, Illinois, 60637
Indiana University School of Optometry
Indianapolis, Indiana, 47405
Gundersen Health System
La Crosse, Wisconsin, 54601
University of Kentucky Department of Neurology
Lexington, Kentucky, 40536
Arkansas Childrens
Little Rock, Arkansas, 72202
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141
Western University College of Optometry
Pomona, California, 91766
OHSU Casey Eye Institute
Portland, Oregon, 97239
Houston Eye Associates
The Woodlands, Texas, 77381
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
About this study
Official title: Intermittent Exotropia Study 6: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia
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
- Being tested
- Prism Glasses, Non-Prism Glasses
- Keywords
- Prism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism GlassesDevice
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 GlassesDevice
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Non-Prism Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (22)
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.
Measured: 8 weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Sep 2019
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exotropia IntermittentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- David G Morrison, MD, Study chair, Vanderbilt University Medical CenterAllison I Summers, OD, MCR, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998670
- Sponsor's protocol ID
- IXT6
- Other IDs
- 2UG1EY011751
- Acronym
- IXT6
- Status last verified
- Sep 2023
- First submitted
- 24 Jun 2019
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37399233Hatt 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.
PubMed 34793970
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Exotropia Study 6: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT03998670
- Acronym / sponsor ID
- IXT6 / IXT6
- Conditions
- Exotropia Intermittent
- Keywords
- Prism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 17 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prism Group | Experimental | Device: Prism GlassesSpectacles 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 |
| Non-Prism Group | Placebo comparator | Device: Non-Prism GlassesSpectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prism GlassesSpectacles 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 | Device | Prism Group |
| Non-Prism GlassesSpectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism | Device | Non-Prism Group |
Primary outcome
Exotropia Control Score at Distance, Continuous Score
Time frame: 8 weeks
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.
22 secondary outcomes
Exotropia Control Score at Distance, % With Treatment Response
Time frame: 8 weeks
Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia
Time frame: 8 Weeks
Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks
Time frame: 8 Weeks
Exotropia Control Score at Near, Continuous Score
Time frame: 8 Weeks
Exodeviation by PACT at Distance, Continuous
Time frame: 8 Weeks
Exodeviation by PACT at Near, Continuous
Time frame: 8 Weeks
Randot Preschool Stereoacuity at Near, Continuous
Time frame: 8 Weeks
Compliance of Spectacle Wear
Time frame: 8 weeks
Child Assessment of Symptoms - Do Your Eyes Hurt?
Time frame: 8 Weeks
Child Assessment of Symptoms - Do Your Eyes Feel Funny?
Time frame: 8 Weeks
Child Assessment of Symptoms - Do You Have Double Vision?
Time frame: 8 Weeks
Child Assessment of Symptoms - Is it Hard for You to Stare at Things?
Time frame: 8 Weeks
Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun?
Time frame: 8 Weeks
Child Assessment of Symptoms - Do Your Eyes go in and Out?
Time frame: 8 Weeks
Child Assessment of Symptoms - Is it Hard to Focus Your Eyes?
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Time frame: 8 Weeks
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Time frame: 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37399233Summers 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 publication: PubMed 34793970Hatt 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.
- PEDIG Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Morrison, MD study chair
Vanderbilt University Medical Center
Allison I Summers, OD, MCR study chair
Oregon Health and Science University
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism Glasses and Non-Prism Glasses in people with Exotropia Intermittent, run by Jaeb Center for Health Research at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exotropia Control Score at Distance, Continuous Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03998670, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.