Trial Outcomes & Findings for Base-in Prism Spectacles for Intermittent Exotropia (NCT NCT03998670)
NCT ID: NCT03998670
Last Updated: 2023-10-04
Results Overview
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.
COMPLETED
NA
61 participants
8 weeks
2023-10-04
Participant Flow
Between 09/01/2019 and 07/30/2020, 61 participants were enrolled into the study across 28 clinical sites. After prism-adaptation testing to confirm eligibility, 4 participants did not meet eligibility criteria and 57 participants were randomized to receive either 40% base-in prism spectacles (n=28) or non-prism spectacles (n=29).
After enrollment testing and prior to randomization, an in-office prism adaptation test was administered so that children with "full" prism adaptation (i.e., deviation magnitude increases by the amount of prism worn) would be excluded from the trial. Of 61 participants enrolled, 4 participants did not meet eligibility criteria after prism-adaptation testing and were dropped prior to randomization.
Participant milestones
| Measure |
Prism Group
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
Prism Glasses: 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 Group
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Base-in Prism Spectacles for Intermittent Exotropia
Baseline characteristics by cohort
| Measure |
Prism Group
n=28 Participants
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
Prism Glasses: 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 Group
n=29 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Suppression
None (0 suppression)
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.4 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
6.8 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
6.6 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Age, Customized
3 to <5 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
5 to <7 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
7 to <9 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
>=9 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Refractive Error Average of Eyes, Continuous
|
0.3 Spherical Equivalent Diopters
STANDARD_DEVIATION 1.0 • n=5 Participants
|
0.1 Spherical Equivalent Diopters
STANDARD_DEVIATION 1.4 • n=7 Participants
|
0.2 Spherical Equivalent Diopters
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Refractive Error Average of Eyes, Categorical
-6.00 to <-2.00 diopters
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Refractive Error Average of Eyes, Categorical
-2.00 to <-1.00 diopters
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Refractive Error Average of Eyes, Categorical
-1.00 to <-0.00 diopters
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Refractive Error Average of Eyes, Categorical
0.00 to <1.00 diopters
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Refractive Error Average of Eyes, Categorical
1.00 to <2.00 diopters
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Treatment for Intermittent Exotropia Prior to Enrollment
Overminus Lenses
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Treatment for Intermittent Exotropia Prior to Enrollment
Patching
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Treatment for Intermittent Exotropia Prior to Enrollment
Patching and Atropine
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Treatment for Intermittent Exotropia Prior to Enrollment
Patching and Overminus Lenses
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Treatment for Intermittent Exotropia Prior to Enrollment
Vision Therapy and Overminus Lenses
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Treatment for Intermittent Exotropia Prior to Enrollment
None
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity at Near, Continuous
|
2.3 log arcsec
STANDARD_DEVIATION 0.4 • n=5 Participants
|
2.3 log arcsec
STANDARD_DEVIATION 0.5 • n=7 Participants
|
2.3 log arcsec
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Randot Preschool Stereoacuity at Near, Categorical
40 (1.60)
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity at Near, Categorical
60 (1.78)
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity at Near, Categorical
100 (2.00)
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity at Near, Categorical
200 (2.30)
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity at Near, Categorical
400 (2.60)
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity at Near, Categorical
800 (2.90)
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity at Near, Categorical
Nil (3.10)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Suppression
Mild (1 suppression)
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Suppression
Moderate (2 suppression)
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Suppression
Dense (3 suppression)
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Suppression
Missing
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Exotropia Control Score at Distance, Continuous
|
3.4 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 0.9 • n=7 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Exotropia Control Score at Near, Continuous
|
2.3 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Exotropia Control Score at Distance, Categorical
0 to <1 unit
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Exotropia Control Score at Distance, Categorical
1 to <2 units
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Exotropia Control Score at Distance, Categorical
2 to <3 units
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Exotropia Control Score at Distance, Categorical
3 to <4 units
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Exotropia Control Score at Distance, Categorical
4 to 5 units
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Exotropia Control Score at Near, Categorical
0 to 1 unit
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Exotropia Control Score at Near, Categorical
1 to <2 units
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Exotropia Control Score at Near, Categorical
2 to <3 units
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Exotropia Control Score at Near, Categorical
3 to <4 units
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Exotropia Control Score at Near, Categorical
4 to 5 units
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Exodeviation by PACT at Distance, Categorical
1 to 9 pd
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Exodeviation by PACT at Distance, Categorical
10 to 15 pd
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Exodeviation by PACT at Distance, Categorical
16 to 18 pd
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Exodeviation by PACT at Distance, Categorical
20 to 25 pd
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Exodeviation by PACT at Distance, Categorical
30 to 35 pd
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Exodeviation by PACT at Distance, Categorical
40 to 45 pd
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Exodeviation by PACT at Distance, Continuous
|
25.1 Prism Diopters (pd)
STANDARD_DEVIATION 4.7 • n=5 Participants
|
24.9 Prism Diopters (pd)
STANDARD_DEVIATION 5.6 • n=7 Participants
|
25.0 Prism Diopters (pd)
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Exodeviation by PACT at Near, Categorical
1 to 9 pd
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Exodeviation by PACT at Near, Categorical
10 to 15 pd
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Exodeviation by PACT at Near, Categorical
16 to 18 pd
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Exodeviation by PACT at Near, Categorical
20 to 25 pd
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Exodeviation by PACT at Near, Categorical
30 to 35 pd
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Exodeviation by PACT at Near, Categorical
40 to 45 pd
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Exodeviation by PACT at Near, Continuous
|
21.5 Prism Diopters (pd)
STANDARD_DEVIATION 5.1 • n=5 Participants
|
21.1 Prism Diopters (pd)
STANDARD_DEVIATION 7.5 • n=7 Participants
|
21.3 Prism Diopters (pd)
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThe 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Exotropia Control Score at Distance, Continuous Score
|
3.6 units on a scale
Standard Deviation 1.3
|
3.3 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 8 weeksThe 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Exotropia Control Score at Distance, % With Treatment Response
|
32 percentage of participants
|
24 percentage of participants
|
SECONDARY outcome
Timeframe: 8 WeeksThe 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia
|
48 percentage of participants
|
51 percentage of participants
|
SECONDARY outcome
Timeframe: 8 WeeksControl 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks
|
0.1 units on a scale
Standard Deviation 1.4
|
-0.2 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 8 WeeksNear 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Exotropia Control Score at Near, Continuous Score
|
1.7 units on a scale
Standard Deviation 1.1
|
1.7 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 8 WeeksThe measure of ocular alignment at distance by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Exodeviation by PACT at Distance, Continuous
|
30.6 prism diopters
Standard Deviation 9.3
|
26.5 prism diopters
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 8 WeeksThe measure of ocular alignment at near by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Exodeviation by PACT at Near, Continuous
|
28.7 prism diopters
Standard Deviation 8.2
|
19.0 prism diopters
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 8 WeeksRandot® 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Randot Preschool Stereoacuity at Near, Continuous
|
2.2 log arc seconds
Standard Deviation 0.4
|
1.9 log arc seconds
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 8 weeksParents 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Compliance of Spectacle Wear
Excellent (76% to 100%)
|
22 Participants
|
22 Participants
|
|
Compliance of Spectacle Wear
Good (51% to 75%)
|
3 Participants
|
2 Participants
|
|
Compliance of Spectacle Wear
Fair (26% to 50%)
|
0 Participants
|
1 Participants
|
|
Compliance of Spectacle Wear
Poor (1% to 25%)
|
0 Participants
|
0 Participants
|
|
Compliance of Spectacle Wear
None (0%)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Child Assessment of Symptoms - Do Your Eyes Hurt?
Never
|
15 Participants
|
22 Participants
|
|
Child Assessment of Symptoms - Do Your Eyes Hurt?
Sometimes
|
6 Participants
|
3 Participants
|
|
Child Assessment of Symptoms - Do Your Eyes Hurt?
Almost Always
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Child Assessment of Symptoms - Do Your Eyes Feel Funny?
Never
|
17 Participants
|
20 Participants
|
|
Child Assessment of Symptoms - Do Your Eyes Feel Funny?
Sometimes
|
7 Participants
|
3 Participants
|
|
Child Assessment of Symptoms - Do Your Eyes Feel Funny?
Almost Always
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Child Assessment of Symptoms - Do You Have Double Vision?
Never
|
17 Participants
|
17 Participants
|
|
Child Assessment of Symptoms - Do You Have Double Vision?
Sometimes
|
8 Participants
|
7 Participants
|
|
Child Assessment of Symptoms - Do You Have Double Vision?
Almost Always
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Child Assessment of Symptoms - Is it Hard for You to Stare at Things?
Never
|
16 Participants
|
15 Participants
|
|
Child Assessment of Symptoms - Is it Hard for You to Stare at Things?
Sometimes
|
7 Participants
|
8 Participants
|
|
Child Assessment of Symptoms - Is it Hard for You to Stare at Things?
Almost Always
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun?
Never
|
11 Participants
|
14 Participants
|
|
Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun?
Sometimes
|
8 Participants
|
5 Participants
|
|
Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun?
Almost Always
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Child Assessment of Symptoms - Do Your Eyes go in and Out?
Never
|
20 Participants
|
19 Participants
|
|
Child Assessment of Symptoms - Do Your Eyes go in and Out?
Sometimes
|
2 Participants
|
3 Participants
|
|
Child Assessment of Symptoms - Do Your Eyes go in and Out?
Almost Always
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Child Assessment of Symptoms - Is it Hard to Focus Your Eyes?
Never
|
16 Participants
|
12 Participants
|
|
Child Assessment of Symptoms - Is it Hard to Focus Your Eyes?
Sometimes
|
5 Participants
|
11 Participants
|
|
Child Assessment of Symptoms - Is it Hard to Focus Your Eyes?
Almost Always
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Never
|
15 Participants
|
14 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Almost Never
|
8 Participants
|
6 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Sometimes
|
2 Participants
|
5 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Often
|
0 Participants
|
0 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches?
Almost Always
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Never
|
16 Participants
|
11 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Almost Never
|
5 Participants
|
4 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Sometimes
|
4 Participants
|
9 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Often
|
0 Participants
|
1 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain?
Almost Always
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Never
|
22 Participants
|
15 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Almost Never
|
2 Participants
|
6 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Sometimes
|
0 Participants
|
3 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Often
|
1 Participants
|
1 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close?
Almost Always
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Never
|
21 Participants
|
21 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Almost Never
|
2 Participants
|
3 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Sometimes
|
1 Participants
|
1 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Often
|
1 Participants
|
0 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision?
Almost Always
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Never
|
12 Participants
|
14 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Almost Never
|
7 Participants
|
3 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Sometimes
|
5 Participants
|
5 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Often
|
0 Participants
|
3 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles?
Almost Always
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Never
|
5 Participants
|
10 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Almost Never
|
11 Participants
|
5 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Sometimes
|
6 Participants
|
8 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Often
|
3 Participants
|
1 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them?
Almost Always
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksAdverse 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Never
|
17 Participants
|
14 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Almost Never
|
3 Participants
|
5 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Sometimes
|
5 Participants
|
5 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Often
|
0 Participants
|
1 Participants
|
|
Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose?
Almost Always
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 WeeksDistance 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Distance Visual Acuity (Snellen Equivalent)
20/16 (best)
|
3 Participants
|
1 Participants
|
|
Distance Visual Acuity (Snellen Equivalent)
20/20
|
10 Participants
|
9 Participants
|
|
Distance Visual Acuity (Snellen Equivalent)
20/25
|
9 Participants
|
8 Participants
|
|
Distance Visual Acuity (Snellen Equivalent)
20/32
|
2 Participants
|
3 Participants
|
|
Distance Visual Acuity (Snellen Equivalent)
20/40
|
1 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 WeeksPopulation: 3 participants in the Prism group and 2 participants in the Non-Prism group were unable to perform testing at 8 weeks and are not included.
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.
Outcome measures
| Measure |
Prism Group
n=22 Participants
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
Prism Glasses: 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 Group
n=23 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Fusional Convergence - Continuous Break Point
|
17.8 prism diopters
Standard Deviation 11.5
|
17.5 prism diopters
Standard Deviation 10.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 WeeksThe 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.
Outcome measures
| Measure |
Prism Group
n=25 Participants
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
Prism Glasses: 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 Group
n=25 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Suppression
None (0 suppression)
|
1 Participants
|
5 Participants
|
|
Suppression
Mild (1 suppression)
|
5 Participants
|
3 Participants
|
|
Suppression
Moderate (2 suppression)
|
6 Participants
|
4 Participants
|
|
Suppression
Dense (3 suppression)
|
12 Participants
|
10 Participants
|
|
Suppression
Missing
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 WeeksPopulation: 3 participants in the Prism group and 2 participants in the Non-Prism group were unable to perform testing at 8 weeks and are not included.
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.
Outcome measures
| Measure |
Prism Group
n=22 Participants
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
Prism Glasses: 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 Group
n=23 Participants
Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant
Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
|
|---|---|---|
|
Fusional Convergence - Continuous Recovery Point
|
9.4 prism diopters
Standard Deviation 10.1
|
10.6 prism diopters
Standard Deviation 9.4
|
Adverse Events
Prism Group
Non-Prism Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Raymond Kraker, PEDIG Coordinating Center Director
PEDIG Coordinating Center, Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place