Adults 3 to 13, any sex, with Exotropia Intermittent. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Exotropia Control Score at Distance, Continuous ScorePrimary· 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.
Group
Value
95% CI
Prism Group
3.6
± 1.3
Non-Prism Group
3.3
± 1.5
Exotropia Control Score at Distance, % With Treatment ResponseSecondary· 8 weeks
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.
Group
Value
95% CI
Prism Group
32
Non-Prism Group
24
Exotropia Control Score at Distance and Near, % With No Spontaneous TropiaSecondary· 8 Weeks
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.
Group
Value
95% CI
Prism Group
48
Non-Prism Group
51
Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 WeeksSecondary· 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
Group
Value
95% CI
Prism Group
0.1
± 1.4
Non-Prism Group
-0.2
± 1.5
Exotropia Control Score at Near, Continuous ScoreSecondary· 8 Weeks
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.
Group
Value
95% CI
Prism Group
1.7
± 1.1
Non-Prism Group
1.7
± 1.3
Exodeviation by PACT at Distance, ContinuousSecondary· 8 Weeks
The measure of ocular alignment at distance by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Group
Value
95% CI
Prism Group
30.6
± 9.3
Non-Prism Group
26.5
± 8.1
Exodeviation by PACT at Near, ContinuousSecondary· 8 Weeks
The measure of ocular alignment at near by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Group
Value
95% CI
Prism Group
28.7
± 8.2
Non-Prism Group
19.0
± 9.8
Randot Preschool Stereoacuity at Near, ContinuousSecondary· 8 Weeks
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.
Group
Value
95% CI
Prism Group
2.2
± 0.4
Non-Prism Group
1.9
± 0.4
Compliance of Spectacle WearSecondary· 8 weeks
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 pick
Excellent (76% to 100%)
Group
Value
95% CI
Prism Group
22
Non-Prism Group
22
Good (51% to 75%)
Group
Value
95% CI
Prism Group
3
Non-Prism Group
2
Fair (26% to 50%)
Group
Value
95% CI
Prism Group
0
Non-Prism Group
1
Poor (1% to 25%)
Group
Value
95% CI
Prism Group
0
Non-Prism Group
0
None (0%)
Group
Value
95% CI
Prism Group
0
Non-Prism Group
0
Child Assessment of Symptoms - Do Your Eyes Hurt?Secondary· 8 Weeks
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.
Never
Group
Value
95% CI
Prism Group
15
Non-Prism Group
22
Sometimes
Group
Value
95% CI
Prism Group
6
Non-Prism Group
3
Almost Always
Group
Value
95% CI
Prism Group
4
Non-Prism Group
0
Child Assessment of Symptoms - Do Your Eyes Feel Funny?Secondary· 8 Weeks
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.
Never
Group
Value
95% CI
Prism Group
17
Non-Prism Group
20
Sometimes
Group
Value
95% CI
Prism Group
7
Non-Prism Group
3
Almost Always
Group
Value
95% CI
Prism Group
1
Non-Prism Group
2
Child Assessment of Symptoms - Do You Have Double Vision?Secondary· 8 Weeks
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.
Never
Group
Value
95% CI
Prism Group
17
Non-Prism Group
17
Sometimes
Group
Value
95% CI
Prism Group
8
Non-Prism Group
7
Almost Always
Group
Value
95% CI
Prism Group
0
Non-Prism Group
1
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jaeb Center for Health Research
Last refreshed: 4 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03998670.