Trial Outcomes & Findings for Trial of Overminus Spectacle Therapy for Intermittent Exotropia (NCT NCT02807350)
NCT ID: NCT02807350
Last Updated: 2022-06-03
Results Overview
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
COMPLETED
NA
386 participants
12 months
2022-06-03
Participant Flow
Participant milestones
| Measure |
Overminus Treatment
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Overall Study
STARTED
|
196
|
190
|
|
Overall Study
6 mo Follow Up Visit
|
188
|
171
|
|
Overall Study
12 mo Follow Up Visit
|
189
|
169
|
|
Overall Study
15 mo Follow Up Visit
|
180
|
153
|
|
Overall Study
COMPLETED
|
176
|
155
|
|
Overall Study
NOT COMPLETED
|
20
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
Baseline characteristics by cohort
| Measure |
Overminus Treatment
n=196 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=190 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
Total
n=386 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
3 to <7 years
|
123 Participants
n=196 Participants
|
120 Participants
n=190 Participants
|
243 Participants
n=386 Participants
|
|
Age, Customized
7 to <11 years
|
73 Participants
n=196 Participants
|
70 Participants
n=190 Participants
|
143 Participants
n=386 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=196 Participants
|
114 Participants
n=190 Participants
|
226 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=196 Participants
|
76 Participants
n=190 Participants
|
160 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
6 Participants
n=196 Participants
|
10 Participants
n=190 Participants
|
16 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
34 Participants
n=196 Participants
|
28 Participants
n=190 Participants
|
62 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
31 Participants
n=196 Participants
|
40 Participants
n=190 Participants
|
71 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
113 Participants
n=196 Participants
|
91 Participants
n=190 Participants
|
204 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
12 Participants
n=196 Participants
|
21 Participants
n=190 Participants
|
33 Participants
n=386 Participants
|
|
Refractive Error
>0.50 Diopters
|
58 Participants
n=196 Participants
|
59 Participants
n=190 Participants
|
117 Participants
n=386 Participants
|
|
Refractive Error
>-0.75 to 0.50 Diopters
|
101 Participants
n=196 Participants
|
96 Participants
n=190 Participants
|
197 Participants
n=386 Participants
|
|
Refractive Error
-0.75 to >-3.00 Diopters
|
29 Participants
n=196 Participants
|
32 Participants
n=190 Participants
|
61 Participants
n=386 Participants
|
|
Refractive Error
<=-3.00 Diopters
|
8 Participants
n=196 Participants
|
3 Participants
n=190 Participants
|
11 Participants
n=386 Participants
|
|
Prior Non Surgical Treatment of IXT
None
|
126 Participants
n=196 Participants
|
137 Participants
n=190 Participants
|
263 Participants
n=386 Participants
|
|
Prior Non Surgical Treatment of IXT
Patching only
|
53 Participants
n=196 Participants
|
33 Participants
n=190 Participants
|
86 Participants
n=386 Participants
|
|
Prior Non Surgical Treatment of IXT
Vision therapy only
|
10 Participants
n=196 Participants
|
11 Participants
n=190 Participants
|
21 Participants
n=386 Participants
|
|
Prior Non Surgical Treatment of IXT
Patching plus other
|
4 Participants
n=196 Participants
|
6 Participants
n=190 Participants
|
10 Participants
n=386 Participants
|
|
Prior Non Surgical Treatment of IXT
Other
|
3 Participants
n=196 Participants
|
3 Participants
n=190 Participants
|
6 Participants
n=386 Participants
|
|
Randot Preschool Stereoacuity test score at near
40-100 arcseconds
|
120 Participants
n=188 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
112 Participants
n=183 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
232 Participants
n=371 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
|
Randot Preschool Stereoacuity test score at near
200-800 arcseconds
|
52 Participants
n=188 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
55 Participants
n=183 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
107 Participants
n=371 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
|
Randot Preschool Stereoacuity test score at near
Nil
|
16 Participants
n=188 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
16 Participants
n=183 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
32 Participants
n=371 Participants • Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.
|
|
Mean distance visual acuity
20/12 to 20/20
|
115 Participants
n=196 Participants
|
112 Participants
n=190 Participants
|
227 Participants
n=386 Participants
|
|
Mean distance visual acuity
20/25 to 20/32
|
70 Participants
n=196 Participants
|
69 Participants
n=190 Participants
|
139 Participants
n=386 Participants
|
|
Mean distance visual acuity
20/40 to 20/50
|
11 Participants
n=196 Participants
|
9 Participants
n=190 Participants
|
20 Participants
n=386 Participants
|
|
IOD of distance visual acuity
0 lines
|
130 Participants
n=196 Participants
|
115 Participants
n=190 Participants
|
245 Participants
n=386 Participants
|
|
IOD of distance visual acuity
0.1 lines
|
57 Participants
n=196 Participants
|
61 Participants
n=190 Participants
|
118 Participants
n=386 Participants
|
|
IOD of distance visual acuity
0.2 lines
|
9 Participants
n=196 Participants
|
14 Participants
n=190 Participants
|
23 Participants
n=386 Participants
|
|
Spectacle wear
Does not wear spectacles
|
140 Participants
n=196 Participants
|
142 Participants
n=190 Participants
|
282 Participants
n=386 Participants
|
|
Spectacle wear
Wearing spectacles for at least 1 week
|
56 Participants
n=196 Participants
|
48 Participants
n=190 Participants
|
104 Participants
n=386 Participants
|
|
Exotropia Control at Distance
0 to <1 points
|
NA Participants
n=196 Participants
|
NA Participants
n=190 Participants
|
NA Participants
n=386 Participants
|
|
Exotropia Control at Distance
1 to <2 points
|
NA Participants
n=196 Participants
|
NA Participants
n=190 Participants
|
NA Participants
n=386 Participants
|
|
Exotropia Control at Distance
2 to <3 points
|
84 Participants
n=196 Participants
|
78 Participants
n=190 Participants
|
162 Participants
n=386 Participants
|
|
Exotropia Control at Distance
3 to <4 points
|
56 Participants
n=196 Participants
|
52 Participants
n=190 Participants
|
108 Participants
n=386 Participants
|
|
Exotropia Control at Distance
4 to 5 points
|
56 Participants
n=196 Participants
|
60 Participants
n=190 Participants
|
116 Participants
n=386 Participants
|
|
Exotropia Control at near
0 to <1 points
|
37 Participants
n=196 Participants
|
46 Participants
n=190 Participants
|
83 Participants
n=386 Participants
|
|
Exotropia Control at near
1 to <2 points
|
80 Participants
n=196 Participants
|
65 Participants
n=190 Participants
|
145 Participants
n=386 Participants
|
|
Exotropia Control at near
2 to <3 points
|
39 Participants
n=196 Participants
|
44 Participants
n=190 Participants
|
83 Participants
n=386 Participants
|
|
Exotropia Control at near
3 to <4 points
|
31 Participants
n=196 Participants
|
27 Participants
n=190 Participants
|
58 Participants
n=386 Participants
|
|
Exotropia Control at near
4 to 5 points
|
9 Participants
n=196 Participants
|
8 Participants
n=190 Participants
|
17 Participants
n=386 Participants
|
|
PACT exodeviation at distance
No exodeviation (orthophoria)
|
NA Participants
n=196 Participants
|
NA Participants
n=190 Participants
|
NA Participants
n=386 Participants
|
|
PACT exodeviation at distance
1-9 Δ
|
NA Participants
n=196 Participants
|
NA Participants
n=190 Participants
|
NA Participants
n=386 Participants
|
|
PACT exodeviation at distance
10-15 Δ
|
5 Participants
n=196 Participants
|
6 Participants
n=190 Participants
|
11 Participants
n=386 Participants
|
|
PACT exodeviation at distance
16-18 Δ
|
42 Participants
n=196 Participants
|
22 Participants
n=190 Participants
|
64 Participants
n=386 Participants
|
|
PACT exodeviation at distance
19-25 Δ
|
86 Participants
n=196 Participants
|
91 Participants
n=190 Participants
|
177 Participants
n=386 Participants
|
|
PACT exodeviation at distance
30-35 Δ
|
54 Participants
n=196 Participants
|
50 Participants
n=190 Participants
|
104 Participants
n=386 Participants
|
|
PACT exodeviation at distance
40-45 Δ
|
9 Participants
n=196 Participants
|
19 Participants
n=190 Participants
|
28 Participants
n=386 Participants
|
|
PACT exodeviation at distance
>= 50 Δ
|
0 Participants
n=196 Participants
|
2 Participants
n=190 Participants
|
2 Participants
n=386 Participants
|
|
PACT exodeviation at distance
Esodeviation
|
NA Participants
n=196 Participants
|
NA Participants
n=190 Participants
|
NA Participants
n=386 Participants
|
|
PACT Exodeviation at near
No Exodeviation (orthophoria)
|
2 Participants
n=196 Participants
|
3 Participants
n=190 Participants
|
5 Participants
n=386 Participants
|
|
PACT Exodeviation at near
1-9 Δ
|
27 Participants
n=196 Participants
|
24 Participants
n=190 Participants
|
51 Participants
n=386 Participants
|
|
PACT Exodeviation at near
10-15 Δ
|
45 Participants
n=196 Participants
|
45 Participants
n=190 Participants
|
90 Participants
n=386 Participants
|
|
PACT Exodeviation at near
16-18 Δ
|
36 Participants
n=196 Participants
|
29 Participants
n=190 Participants
|
65 Participants
n=386 Participants
|
|
PACT Exodeviation at near
19-25 Δ
|
57 Participants
n=196 Participants
|
59 Participants
n=190 Participants
|
116 Participants
n=386 Participants
|
|
PACT Exodeviation at near
30-35 Δ
|
24 Participants
n=196 Participants
|
21 Participants
n=190 Participants
|
45 Participants
n=386 Participants
|
|
PACT Exodeviation at near
40-45 Δ
|
4 Participants
n=196 Participants
|
8 Participants
n=190 Participants
|
12 Participants
n=386 Participants
|
|
PACT Exodeviation at near
>= 50 Δ
|
1 Participants
n=196 Participants
|
0 Participants
n=190 Participants
|
1 Participants
n=386 Participants
|
|
PACT Exodeviation at near
Esodeviation
|
0 Participants
n=196 Participants
|
1 Participants
n=190 Participants
|
1 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: 12 monthsA comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Mean Distance Control at 12-Months (On-Treatment Visit)
|
1.8 points
Standard Deviation 1.3
|
2.8 points
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 18 monthsA comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Mean Distance Control at 18-Months (Off-Treatment Visit)
|
2.4 points
Standard Deviation 1.5
|
2.7 points
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 12 monthsThe number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Number of Participants With No Spontaneous Tropia
|
115 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: At 18 monthsThe proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
No Spontaneous Tropia
|
85 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Change in Distance Control
>2 Points
|
65 Participants
|
24 Participants
|
|
Change in Distance Control
>1 Point
|
116 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: 18 monthsThe proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Change in Distance Control
>1 Point
|
86 Participants
|
68 Participants
|
|
Change in Distance Control
>2 Points
|
48 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. * Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. * Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 18 monthsThe cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. * Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. * Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)
|
6 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 12 monthsMean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Near Control (12 Months)
0 to <1 points
|
96 Participants
|
64 Participants
|
|
Near Control (12 Months)
1 to <2 points
|
59 Participants
|
55 Participants
|
|
Near Control (12 Months)
2 to <3 points
|
21 Participants
|
13 Participants
|
|
Near Control (12 Months)
3 to <4 points
|
9 Participants
|
17 Participants
|
|
Near Control (12 Months)
4 to 5 points
|
4 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 18 monthsMean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Near Control (18 Months)
4 to 5 points
|
13 Participants
|
16 Participants
|
|
Near Control (18 Months)
0 to <1 points
|
72 Participants
|
59 Participants
|
|
Near Control (18 Months)
1 to <2 points
|
60 Participants
|
46 Participants
|
|
Near Control (18 Months)
2 to <3 points
|
16 Participants
|
18 Participants
|
|
Near Control (18 Months)
3 to <4 points
|
15 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 12 monthsFor each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Change in Near Control (12 Months)
|
0.7 points
Standard Deviation 1.3
|
0.1 points
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 18 monthsFor each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Change in Near Control (18 Months)
|
0.4 points
Standard Deviation 1.4
|
0.1 points
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 monthsThe magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Angle Magnitude (12 Months)
|
20.0 Prism Diopters
Standard Deviation 9.0
|
25.0 Prism Diopters
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 18 monthsThe magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Angle Magnitude (18 Months)
|
23.0 Prism Diopters
Standard Deviation 9.0
|
24.0 Prism Diopters
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 12 monthsA comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Stereoacuity at 12 Months
|
2.0 arcseconds
Standard Deviation 0.4
|
2.0 arcseconds
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 18 monthsA comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Stereoacuity at 18 Months
|
1.9 arcseconds
Standard Deviation 0.4
|
1.9 arcseconds
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 12 monthsCompliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Compliance With Spectacle Wear (12 Months)
Prescribed not wearing (0%)
|
3 Participants
|
2 Participants
|
|
Compliance With Spectacle Wear (12 Months)
Discontinued
|
1 Participants
|
1 Participants
|
|
Compliance With Spectacle Wear (12 Months)
Excellent (76-100%)
|
143 Participants
|
128 Participants
|
|
Compliance With Spectacle Wear (12 Months)
Good (51-75%)
|
26 Participants
|
28 Participants
|
|
Compliance With Spectacle Wear (12 Months)
Fair (26-50%)
|
10 Participants
|
8 Participants
|
|
Compliance With Spectacle Wear (12 Months)
Poor (1-25%)
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 18 monthsCompliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Compliance With Spectacle Wear (18 Months)
Good (51-75%)
|
23 Participants
|
14 Participants
|
|
Compliance With Spectacle Wear (18 Months)
Excellent (76-100%)
|
128 Participants
|
120 Participants
|
|
Compliance With Spectacle Wear (18 Months)
Fair (26-50%)
|
8 Participants
|
13 Participants
|
|
Compliance With Spectacle Wear (18 Months)
Poor (1-25%)
|
9 Participants
|
5 Participants
|
|
Compliance With Spectacle Wear (18 Months)
Prescribed not wearing (0%)
|
5 Participants
|
1 Participants
|
|
Compliance With Spectacle Wear (18 Months)
Discontinued
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: When number analyzed differs from full population size, it indicates that those children were not wearing spectacles, and therefore could not answer the spectacle related questions.
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Outcome measures
| Measure |
Overminus Treatment
n=189 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=169 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Parent Symptom Survey [12 Months]
Did your child have blurry vision? · Missing
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have blurry vision? · Often
|
5 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have blurry vision? · Almost Always
|
2 Participants
|
0 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child look over their spectacles? · Missing
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child look over their spectacles? · Sometimes
|
45 Participants
|
52 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child complain about hurt ears/nose? · Missing
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have headaches? · Missing
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have headaches? · Never
|
74 Participants
|
71 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have headaches? · Almost never
|
58 Participants
|
64 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have headaches? · Sometimes
|
46 Participants
|
32 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have headaches? · Often
|
7 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have headaches? · Almost Always
|
3 Participants
|
0 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have eyestrain? · Missing
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have eyestrain? · Never
|
75 Participants
|
56 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have eyestrain? · Almost never
|
43 Participants
|
56 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have eyestrain? · Sometimes
|
60 Participants
|
50 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have eyestrain? · Often
|
9 Participants
|
6 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have eyestrain? · Almost Always
|
1 Participants
|
0 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child avoid reading? · Missing
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child avoid reading? · Never
|
112 Participants
|
100 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child avoid reading? · Almost never
|
46 Participants
|
43 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child avoid reading? · Sometimes
|
21 Participants
|
18 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child avoid reading? · Often
|
7 Participants
|
5 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child avoid reading? · Almost Always
|
2 Participants
|
2 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have blurry vision? · Never
|
106 Participants
|
105 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have blurry vision? · Almost never
|
41 Participants
|
36 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child have blurry vision? · Sometimes
|
34 Participants
|
26 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child look over their spectacles? · Never
|
66 Participants
|
53 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child look over their spectacles? · Almost never
|
37 Participants
|
40 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child look over their spectacles? · Often
|
25 Participants
|
17 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child look over their spectacles? · Almost Always
|
11 Participants
|
4 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child take their spectacles off? · Missing
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child take their spectacles off? · Never
|
38 Participants
|
32 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child take their spectacles off? · Almost never
|
45 Participants
|
51 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child take their spectacles off? · Sometimes
|
63 Participants
|
66 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child take their spectacles off? · Often
|
28 Participants
|
16 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child take their spectacles off? · Almost Always
|
10 Participants
|
2 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child complain about hurt ears/nose? · Never
|
112 Participants
|
96 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child complain about hurt ears/nose? · Almost never
|
43 Participants
|
47 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child complain about hurt ears/nose? · Sometimes
|
18 Participants
|
22 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child complain about hurt ears/nose? · Often
|
10 Participants
|
2 Participants
|
|
Parent Symptom Survey [12 Months]
Did your child complain about hurt ears/nose? · Almost Always
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 18 monthsPopulation: When number analyzed differs from full population size, it indicates that those children were not wearing spectacles, and therefore could not answer the spectacle related questions.
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Outcome measures
| Measure |
Overminus Treatment
n=176 Participants
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=155 Participants
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Parent Symptom Survey [18 Months]
Did your child have eyestrain? · Sometimes
|
53 Participants
|
49 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have eyestrain? · Often
|
3 Participants
|
6 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have eyestrain? · Almost always
|
2 Participants
|
0 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child avoid reading? · Missing
|
0 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child avoid reading? · Never
|
102 Participants
|
94 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child avoid reading? · Almost never
|
44 Participants
|
41 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child avoid reading? · Sometimes
|
24 Participants
|
14 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child avoid reading? · Often
|
4 Participants
|
4 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child avoid reading? · Almost always
|
2 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have blurry vision? · Missing
|
0 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have blurry vision? · Never
|
99 Participants
|
92 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have blurry vision? · Almost never
|
46 Participants
|
37 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have blurry vision? · Sometimes
|
29 Participants
|
23 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have blurry vision? · Often
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have blurry vision? · Almost always
|
1 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child look over their spectacles? · Missing
|
0 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child look over their spectacles? · Never
|
54 Participants
|
55 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child look over their spectacles? · Almost never
|
46 Participants
|
33 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child look over their spectacles? · Sometimes
|
47 Participants
|
48 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child look over their spectacles? · Often
|
18 Participants
|
9 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child look over their spectacles? · Almost always
|
8 Participants
|
5 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child take their spectacles off? · Missing
|
0 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child take their spectacles off? · Never
|
38 Participants
|
32 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child take their spectacles off? · Almost never
|
36 Participants
|
43 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child take their spectacles off? · Sometimes
|
69 Participants
|
55 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child take their spectacles off? · Often
|
22 Participants
|
13 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child take their spectacles off? · Almost always
|
7 Participants
|
8 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child complain about hurt ears/nose? · Missing
|
0 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child complain about hurt ears/nose? · Never
|
109 Participants
|
96 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child complain about hurt ears/nose? · Almost never
|
41 Participants
|
36 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child complain about hurt ears/nose? · Sometimes
|
18 Participants
|
14 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child complain about hurt ears/nose? · Often
|
2 Participants
|
4 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child complain about hurt ears/nose? · Almost always
|
4 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have headaches? · Missing
|
0 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have headaches? · Never
|
76 Participants
|
63 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have headaches? · Almost never
|
49 Participants
|
55 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have headaches? · Sometimes
|
46 Participants
|
31 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have headaches? · Often
|
4 Participants
|
3 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have headaches? · Almost always
|
1 Participants
|
2 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have eyestrain? · Missing
|
0 Participants
|
1 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have eyestrain? · Never
|
66 Participants
|
49 Participants
|
|
Parent Symptom Survey [18 Months]
Did your child have eyestrain? · Almost never
|
52 Participants
|
50 Participants
|
Adverse Events
Overminus Treatment
Non-overminus Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overminus Treatment
n=196 participants at risk
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
|
Non-overminus Treatment
n=190 participants at risk
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment: spectacles with full cycloplegic refraction without overminus
|
|---|---|---|
|
Eye disorders
Development of Esotropia
|
2.0%
4/196 • Number of events 4 • 18 months
Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
|
2.1%
4/190 • Number of events 4 • 18 months
Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
|
|
Eye disorders
>1 Diopter of Myopic Shift
|
16.8%
33/196 • Number of events 33 • 18 months
Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
|
1.1%
2/190 • Number of events 2 • 18 months
Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
|
|
Eye disorders
2 or more line decrease in visual acuity
|
6.1%
12/196 • Number of events 12 • 18 months
Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
|
5.3%
10/190 • Number of events 10 • 18 months
Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
|
|
Eye disorders
Amblyopia treatment prescribed by 12 months
|
1.0%
2/196 • Number of events 2 • 18 months
Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
|
0.53%
1/190 • Number of events 1 • 18 months
Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.
|
Additional Information
Raymond Kraker, Coordinating Center Director
Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place