Trial Outcomes & Findings for Observation Versus Occlusion Therapy for Intermittent Exotropia (NCT NCT01032330)
NCT ID: NCT01032330
Last Updated: 2020-05-19
Results Overview
The primary outcome measure for this study was whether the participant's condition had deteriorated within 6 months after randomization. Deterioration was defined as meeting one or both of the following criteria during a masked examination at either the 3-month or 6-month visit: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.
COMPLETED
NA
611 participants
6 months
2020-05-19
Participant Flow
Aside from the two primary cohorts (older and younger), there were 52 patients in a separate exploratory cohort of patients who had little or no stereoacuity (800 or Nil); this cohort is not being reported based on the criteria listed in the protocol.
Participant milestones
| Measure |
Older Cohort Observation Group
Older Cohort patients aged 3 to \<12 years randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: Older cohort patients aged 3 to \<12 years randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
Younger cohort patients aged 12 to 35 months randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Younger cohort patients aged 12 to 35 months randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
183
|
175
|
97
|
104
|
|
Overall Study
COMPLETED
|
165
|
151
|
87
|
90
|
|
Overall Study
NOT COMPLETED
|
18
|
24
|
10
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
Baseline characteristics by cohort
| Measure |
Older Cohort Observation Group
n=183 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
n=175 Participants
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=97 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
n=104 Participants
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Total
n=559 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
183 Participants
n=183 Participants
|
175 Participants
n=175 Participants
|
97 Participants
n=97 Participants
|
104 Participants
n=104 Participants
|
559 Participants
n=559 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=559 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=559 Participants
|
|
Age, Continuous
|
6.1 years
STANDARD_DEVIATION 2.0 • n=183 Participants
|
5.9 years
STANDARD_DEVIATION 2.0 • n=175 Participants
|
2.0 years
STANDARD_DEVIATION 0.54 • n=97 Participants
|
2.0 years
STANDARD_DEVIATION 0.57 • n=104 Participants
|
6.0 years
STANDARD_DEVIATION 2.0 • n=559 Participants
|
|
Age, Customized
3 to <5 years
|
61 Participants
n=183 Participants
|
68 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
129 Participants
n=559 Participants
|
|
Age, Customized
5 to <7 years
|
67 Participants
n=183 Participants
|
64 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
131 Participants
n=559 Participants
|
|
Age, Customized
7 to <9 years
|
33 Participants
n=183 Participants
|
26 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
59 Participants
n=559 Participants
|
|
Age, Customized
9 to <11 years
|
22 Participants
n=183 Participants
|
17 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
39 Participants
n=559 Participants
|
|
Age, Customized
1 to <1.5 years
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
22 Participants
n=97 Participants
|
23 Participants
n=104 Participants
|
45 Participants
n=559 Participants
|
|
Age, Customized
1.5 to <2 years
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
28 Participants
n=97 Participants
|
18 Participants
n=104 Participants
|
46 Participants
n=559 Participants
|
|
Age, Customized
2 to <2.5 years
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
24 Participants
n=97 Participants
|
34 Participants
n=104 Participants
|
58 Participants
n=559 Participants
|
|
Age, Customized
2.5 to <3 years
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
23 Participants
n=97 Participants
|
28 Participants
n=104 Participants
|
51 Participants
n=559 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=183 Participants
|
98 Participants
n=175 Participants
|
58 Participants
n=97 Participants
|
66 Participants
n=104 Participants
|
337 Participants
n=559 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=183 Participants
|
77 Participants
n=175 Participants
|
39 Participants
n=97 Participants
|
38 Participants
n=104 Participants
|
222 Participants
n=559 Participants
|
|
Race/Ethnicity, Customized
White
|
112 Participants
n=183 Participants
|
109 Participants
n=175 Participants
|
65 Participants
n=97 Participants
|
60 Participants
n=104 Participants
|
346 Participants
n=559 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
23 Participants
n=183 Participants
|
25 Participants
n=175 Participants
|
13 Participants
n=97 Participants
|
14 Participants
n=104 Participants
|
75 Participants
n=559 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
32 Participants
n=183 Participants
|
22 Participants
n=175 Participants
|
13 Participants
n=97 Participants
|
21 Participants
n=104 Participants
|
88 Participants
n=559 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=183 Participants
|
13 Participants
n=175 Participants
|
6 Participants
n=97 Participants
|
9 Participants
n=104 Participants
|
42 Participants
n=559 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
2 Participants
n=183 Participants
|
6 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
8 Participants
n=559 Participants
|
|
Average Visual Acuity
20/12 or 20/16
|
21 Participants
n=183 Participants
|
22 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
43 Participants
n=559 Participants
|
|
Average Visual Acuity
20/20
|
65 Participants
n=183 Participants
|
70 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
135 Participants
n=559 Participants
|
|
Average Visual Acuity
20/25
|
73 Participants
n=183 Participants
|
45 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
118 Participants
n=559 Participants
|
|
Average Visual Acuity
20/32
|
17 Participants
n=183 Participants
|
28 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
45 Participants
n=559 Participants
|
|
Average Visual Acuity
20/40 or worse
|
7 Participants
n=183 Participants
|
6 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
13 Participants
n=559 Participants
|
|
Average Visual Acuity
|
0.04 logMAR
STANDARD_DEVIATION .09 • n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
0.04 logMAR
STANDARD_DEVIATION .10 • n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
0.04 logMAR
STANDARD_DEVIATION 0.10 • n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Interocular difference in visual acuity (lines)
0
|
86 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
85 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
171 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Interocular difference in visual acuity (lines)
>0 to<1
|
45 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
37 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
82 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Interocular difference in visual acuity (lines)
1
|
42 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
43 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
85 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Interocular difference in visual acuity (lines)
>1 to<2
|
4 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
5 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
9 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Interocular difference in visual acuity (lines)
2
|
6 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
1 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
7 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Interocular difference in visual acuity (lines)
|
0.05 logMAR
STANDARD_DEVIATION 0.06 • n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
0.04 logMAR
STANDARD_DEVIATION 0.05 • n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
0.04 logMAR
STANDARD_DEVIATION 0.05 • n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Spectacle Wear
|
42 Participants
n=183 Participants
|
38 Participants
n=175 Participants
|
5 Participants
n=97 Participants
|
9 Participants
n=104 Participants
|
94 Participants
n=559 Participants
|
|
Preschool Randot Near Stereoacuity (arcsec)
40
|
75 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
69 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
144 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Preschool Randot Near Stereoacuity (arcsec)
60
|
39 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
43 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
82 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Preschool Randot Near Stereoacuity (arcsec)
100
|
43 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
25 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
68 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Preschool Randot Near Stereoacuity (arcsec)
200
|
19 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
16 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
35 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Preschool Randot Near Stereoacuity (arcsec)
400
|
7 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
22 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
29 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Preschool Randot Near Stereoacuity (arcsec)
|
1.84 log arcsec
STANDARD_DEVIATION 0.27 • n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
1.89 log arcsec
STANDARD_DEVIATION 0.34 • n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
1.87 log arcsec
STANDARD_DEVIATION 0.31 • n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Distance Randot Stereoacuity (arcsec)
60
|
64 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
77 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
141 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Distance Randot Stereoacuity (arcsec)
100
|
39 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
38 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
77 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Distance Randot Stereoacuity (arcsec)
200
|
30 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
23 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
53 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Distance Randot Stereoacuity (arcsec)
400
|
18 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
20 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
38 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Distance Randot Stereoacuity (arcsec)
Nil
|
28 Participants
n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
16 Participants
n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
44 Participants
n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Distance Randot Stereoacuity (arcsec)
|
2.22 log arcsec
STANDARD_DEVIATION 0.50 • n=183 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
2.12 log arcsec
STANDARD_DEVIATION 0.44 • n=175 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
—
|
—
|
2.17 log arcsec
STANDARD_DEVIATION 0.47 • n=358 Participants • This measure was used exclusively with the older cohort, no data reported on this characteristic for the younger cohort.
|
|
Exotropia Type
Basic
|
127 Participants
n=183 Participants
|
119 Participants
n=175 Participants
|
61 Participants
n=97 Participants
|
71 Participants
n=104 Participants
|
378 Participants
n=559 Participants
|
|
Exotropia Type
Convergence insufficiency
|
5 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
2 Participants
n=97 Participants
|
1 Participants
n=104 Participants
|
8 Participants
n=559 Participants
|
|
Exotropia Type
High AC/A
|
4 Participants
n=183 Participants
|
7 Participants
n=175 Participants
|
2 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
13 Participants
n=559 Participants
|
|
Exotropia Type
Pseudodivergence excess
|
39 Participants
n=183 Participants
|
39 Participants
n=175 Participants
|
26 Participants
n=97 Participants
|
24 Participants
n=104 Participants
|
128 Participants
n=559 Participants
|
|
Exotropia Type
True divergence excess
|
7 Participants
n=183 Participants
|
10 Participants
n=175 Participants
|
5 Participants
n=97 Participants
|
8 Participants
n=104 Participants
|
30 Participants
n=559 Participants
|
|
Exotropia Type
Missing exotropia classification
|
1 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
1 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
2 Participants
n=559 Participants
|
|
Deviation Type
Distance · Constant exotropia
|
9 Participants
n=183 Participants
|
8 Participants
n=175 Participants
|
9 Participants
n=97 Participants
|
3 Participants
n=104 Participants
|
29 Participants
n=559 Participants
|
|
Deviation Type
Distance · Intermittent exotropia
|
174 Participants
n=183 Participants
|
167 Participants
n=175 Participants
|
88 Participants
n=97 Participants
|
101 Participants
n=104 Participants
|
530 Participants
n=559 Participants
|
|
Deviation Type
Distance · Exophoria
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=559 Participants
|
|
Deviation Type
Distance · No Exodeviation
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=559 Participants
|
|
Deviation Type
Near · Constant exotropia
|
1 Participants
n=183 Participants
|
1 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
2 Participants
n=559 Participants
|
|
Deviation Type
Near · Intermittent exotropia
|
129 Participants
n=183 Participants
|
119 Participants
n=175 Participants
|
69 Participants
n=97 Participants
|
72 Participants
n=104 Participants
|
389 Participants
n=559 Participants
|
|
Deviation Type
Near · Exophoria
|
49 Participants
n=183 Participants
|
44 Participants
n=175 Participants
|
21 Participants
n=97 Participants
|
21 Participants
n=104 Participants
|
135 Participants
n=559 Participants
|
|
Deviation Type
Near · No Exodeviation
|
4 Participants
n=183 Participants
|
11 Participants
n=175 Participants
|
7 Participants
n=97 Participants
|
11 Participants
n=104 Participants
|
33 Participants
n=559 Participants
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Distance · 0 (no measureable tropia)
|
48 Participants
n=183 Participants • One participant was missing SPCT at near
|
50 Participants
n=175 Participants • One participant was missing SPCT at near
|
28 Participants
n=97 Participants • One participant was missing SPCT at near
|
41 Participants
n=104 Participants • One participant was missing SPCT at near
|
167 Participants
n=559 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Distance · 1-9
|
15 Participants
n=183 Participants • One participant was missing SPCT at near
|
18 Participants
n=175 Participants • One participant was missing SPCT at near
|
8 Participants
n=97 Participants • One participant was missing SPCT at near
|
7 Participants
n=104 Participants • One participant was missing SPCT at near
|
48 Participants
n=559 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Distance · 10-14
|
18 Participants
n=183 Participants • One participant was missing SPCT at near
|
12 Participants
n=175 Participants • One participant was missing SPCT at near
|
4 Participants
n=97 Participants • One participant was missing SPCT at near
|
5 Participants
n=104 Participants • One participant was missing SPCT at near
|
39 Participants
n=559 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Distance · 16-18
|
30 Participants
n=183 Participants • One participant was missing SPCT at near
|
29 Participants
n=175 Participants • One participant was missing SPCT at near
|
8 Participants
n=97 Participants • One participant was missing SPCT at near
|
13 Participants
n=104 Participants • One participant was missing SPCT at near
|
80 Participants
n=559 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Distance · 20-25
|
57 Participants
n=183 Participants • One participant was missing SPCT at near
|
47 Participants
n=175 Participants • One participant was missing SPCT at near
|
30 Participants
n=97 Participants • One participant was missing SPCT at near
|
21 Participants
n=104 Participants • One participant was missing SPCT at near
|
155 Participants
n=559 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Distance · 30-35
|
13 Participants
n=183 Participants • One participant was missing SPCT at near
|
15 Participants
n=175 Participants • One participant was missing SPCT at near
|
16 Participants
n=97 Participants • One participant was missing SPCT at near
|
12 Participants
n=104 Participants • One participant was missing SPCT at near
|
56 Participants
n=559 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Distance · 40-50
|
2 Participants
n=183 Participants • One participant was missing SPCT at near
|
4 Participants
n=175 Participants • One participant was missing SPCT at near
|
3 Participants
n=97 Participants • One participant was missing SPCT at near
|
3 Participants
n=104 Participants • One participant was missing SPCT at near
|
12 Participants
n=559 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Distance · >50
|
0 Participants
n=183 Participants • One participant was missing SPCT at near
|
0 Participants
n=175 Participants • One participant was missing SPCT at near
|
0 Participants
n=97 Participants • One participant was missing SPCT at near
|
2 Participants
n=104 Participants • One participant was missing SPCT at near
|
2 Participants
n=559 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Near · 0 (no measureable tropia)
|
108 Participants
n=183 Participants • One participant was missing SPCT at near
|
108 Participants
n=175 Participants • One participant was missing SPCT at near
|
63 Participants
n=97 Participants • One participant was missing SPCT at near
|
75 Participants
n=103 Participants • One participant was missing SPCT at near
|
354 Participants
n=558 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Near · 1-9
|
23 Participants
n=183 Participants • One participant was missing SPCT at near
|
27 Participants
n=175 Participants • One participant was missing SPCT at near
|
11 Participants
n=97 Participants • One participant was missing SPCT at near
|
8 Participants
n=103 Participants • One participant was missing SPCT at near
|
69 Participants
n=558 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Near · 10-14
|
21 Participants
n=183 Participants • One participant was missing SPCT at near
|
11 Participants
n=175 Participants • One participant was missing SPCT at near
|
4 Participants
n=97 Participants • One participant was missing SPCT at near
|
3 Participants
n=103 Participants • One participant was missing SPCT at near
|
39 Participants
n=558 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Near · 16-18
|
13 Participants
n=183 Participants • One participant was missing SPCT at near
|
12 Participants
n=175 Participants • One participant was missing SPCT at near
|
3 Participants
n=97 Participants • One participant was missing SPCT at near
|
4 Participants
n=103 Participants • One participant was missing SPCT at near
|
32 Participants
n=558 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Near · 20-25
|
14 Participants
n=183 Participants • One participant was missing SPCT at near
|
9 Participants
n=175 Participants • One participant was missing SPCT at near
|
12 Participants
n=97 Participants • One participant was missing SPCT at near
|
9 Participants
n=103 Participants • One participant was missing SPCT at near
|
44 Participants
n=558 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Near · 30-35
|
4 Participants
n=183 Participants • One participant was missing SPCT at near
|
5 Participants
n=175 Participants • One participant was missing SPCT at near
|
3 Participants
n=97 Participants • One participant was missing SPCT at near
|
3 Participants
n=103 Participants • One participant was missing SPCT at near
|
15 Participants
n=558 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Near · 40-50
|
0 Participants
n=183 Participants • One participant was missing SPCT at near
|
3 Participants
n=175 Participants • One participant was missing SPCT at near
|
1 Participants
n=97 Participants • One participant was missing SPCT at near
|
1 Participants
n=103 Participants • One participant was missing SPCT at near
|
5 Participants
n=558 Participants • One participant was missing SPCT at near
|
|
Exotropia (∆) by Simultaneous Prism Cover Test (SPCT)
Near · >50
|
0 Participants
n=183 Participants • One participant was missing SPCT at near
|
0 Participants
n=175 Participants • One participant was missing SPCT at near
|
0 Participants
n=97 Participants • One participant was missing SPCT at near
|
0 Participants
n=103 Participants • One participant was missing SPCT at near
|
0 Participants
n=558 Participants • One participant was missing SPCT at near
|
|
Average Exotropia (∆) by SPCT
Distance
|
16 Prism Diopters
n=183 Participants
|
16 Prism Diopters
n=175 Participants
|
20 Prism Diopters
n=97 Participants
|
14 Prism Diopters
n=104 Participants
|
16 Prism Diopters
n=559 Participants
|
|
Average Exotropia (∆) by SPCT
Near
|
0 Prism Diopters
n=183 Participants
|
0 Prism Diopters
n=175 Participants
|
0 Prism Diopters
n=97 Participants
|
0 Prism Diopters
n=104 Participants
|
0 Prism Diopters
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Distance · No exodeviation (orthophoria)
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Distance · 1-9
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
00 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Distance · 10-14
|
7 Participants
n=183 Participants
|
11 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
18 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Distance · 16-18
|
34 Participants
n=183 Participants
|
33 Participants
n=175 Participants
|
9 Participants
n=97 Participants
|
14 Participants
n=104 Participants
|
90 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Distance · 20-25
|
101 Participants
n=183 Participants
|
87 Participants
n=175 Participants
|
44 Participants
n=97 Participants
|
44 Participants
n=104 Participants
|
276 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Distance · 30-35
|
35 Participants
n=183 Participants
|
39 Participants
n=175 Participants
|
39 Participants
n=97 Participants
|
36 Participants
n=104 Participants
|
149 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Distance · 40-45
|
5 Participants
n=183 Participants
|
5 Participants
n=175 Participants
|
3 Participants
n=97 Participants
|
8 Participants
n=104 Participants
|
21 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Distance · ≥50
|
1 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
2 Participants
n=97 Participants
|
2 Participants
n=104 Participants
|
5 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Near · No exodeviation (orthophoria)
|
6 Participants
n=183 Participants
|
7 Participants
n=175 Participants
|
9 Participants
n=97 Participants
|
13 Participants
n=104 Participants
|
35 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Near · 1-9
|
19 Participants
n=183 Participants
|
31 Participants
n=175 Participants
|
7 Participants
n=97 Participants
|
8 Participants
n=104 Participants
|
65 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Near · 10-14
|
49 Participants
n=183 Participants
|
45 Participants
n=175 Participants
|
24 Participants
n=97 Participants
|
15 Participants
n=104 Participants
|
133 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Near · 16-18
|
32 Participants
n=183 Participants
|
24 Participants
n=175 Participants
|
9 Participants
n=97 Participants
|
13 Participants
n=104 Participants
|
78 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Near · 20-25
|
52 Participants
n=183 Participants
|
48 Participants
n=175 Participants
|
30 Participants
n=97 Participants
|
30 Participants
n=104 Participants
|
160 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Near · 30-35
|
21 Participants
n=183 Participants
|
15 Participants
n=175 Participants
|
14 Participants
n=97 Participants
|
18 Participants
n=104 Participants
|
68 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Near · 40-45
|
4 Participants
n=183 Participants
|
5 Participants
n=175 Participants
|
3 Participants
n=97 Participants
|
5 Participants
n=104 Participants
|
17 Participants
n=559 Participants
|
|
Exodeviation (∆) by Prism and Alternate Cover Test (PACT)
Near · ≥50
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
1 Participants
n=97 Participants
|
2 Participants
n=104 Participants
|
3 Participants
n=559 Participants
|
|
Average Exodeviation (∆) by PACT
Distance
|
23.3 Prism Diopters
STANDARD_DEVIATION 6.7 • n=183 Participants
|
23.6 Prism Diopters
STANDARD_DEVIATION 6.7 • n=175 Participants
|
27.4 Prism Diopters
STANDARD_DEVIATION 7.1 • n=97 Participants
|
27.2 Prism Diopters
STANDARD_DEVIATION 8.2 • n=104 Participants
|
24.8 Prism Diopters
STANDARD_DEVIATION 7.3 • n=559 Participants
|
|
Average Exodeviation (∆) by PACT
Near
|
18.0 Prism Diopters
STANDARD_DEVIATION 8.9 • n=183 Participants
|
16.7 Prism Diopters
STANDARD_DEVIATION 9.3 • n=175 Participants
|
18.1 Prism Diopters
STANDARD_DEVIATION 10.8 • n=97 Participants
|
19.4 Prism Diopters
STANDARD_DEVIATION 12.1 • n=104 Participants
|
17.8 Prism Diopters
STANDARD_DEVIATION 10.0 • n=559 Participants
|
|
Exotropia control score
Distance · No exodeviation
|
0 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=559 Participants
|
|
Exotropia control score
Distance · No XT unless dissociated, recovers <1 sec
|
5 Participants
n=183 Participants
|
5 Participants
n=175 Participants
|
2 Participants
n=97 Participants
|
2 Participants
n=104 Participants
|
14 Participants
n=559 Participants
|
|
Exotropia control score
Distance · No XT unless dissociated, recovers 1-5 sec
|
34 Participants
n=183 Participants
|
47 Participants
n=175 Participants
|
18 Participants
n=97 Participants
|
27 Participants
n=104 Participants
|
126 Participants
n=559 Participants
|
|
Exotropia control score
Distance · No XT unless dissociated, recovers >5 sec
|
71 Participants
n=183 Participants
|
56 Participants
n=175 Participants
|
38 Participants
n=97 Participants
|
33 Participants
n=104 Participants
|
198 Participants
n=559 Participants
|
|
Exotropia control score
Distance · XT <50% of 30-seconds
|
40 Participants
n=183 Participants
|
37 Participants
n=175 Participants
|
19 Participants
n=97 Participants
|
27 Participants
n=104 Participants
|
123 Participants
n=559 Participants
|
|
Exotropia control score
Distance · XT >50% of 30-seconds
|
21 Participants
n=183 Participants
|
19 Participants
n=175 Participants
|
11 Participants
n=97 Participants
|
11 Participants
n=104 Participants
|
62 Participants
n=559 Participants
|
|
Exotropia control score
Distance · Constant XT
|
12 Participants
n=183 Participants
|
11 Participants
n=175 Participants
|
9 Participants
n=97 Participants
|
4 Participants
n=104 Participants
|
36 Participants
n=559 Participants
|
|
Exotropia control score
Near · No exodeviation
|
5 Participants
n=183 Participants
|
7 Participants
n=175 Participants
|
3 Participants
n=97 Participants
|
10 Participants
n=104 Participants
|
25 Participants
n=559 Participants
|
|
Exotropia control score
Near · No XT unless dissociated, recovers <1 sec
|
58 Participants
n=183 Participants
|
58 Participants
n=175 Participants
|
31 Participants
n=97 Participants
|
28 Participants
n=104 Participants
|
175 Participants
n=559 Participants
|
|
Exotropia control score
Near · No XT unless dissociated, recovers 1-5 sec
|
71 Participants
n=183 Participants
|
63 Participants
n=175 Participants
|
30 Participants
n=97 Participants
|
39 Participants
n=104 Participants
|
203 Participants
n=559 Participants
|
|
Exotropia control score
Near · No XT unless dissociated, recovers >5 sec
|
28 Participants
n=183 Participants
|
26 Participants
n=175 Participants
|
17 Participants
n=97 Participants
|
15 Participants
n=104 Participants
|
86 Participants
n=559 Participants
|
|
Exotropia control score
Near · XT <50% of 30-seconds
|
18 Participants
n=183 Participants
|
14 Participants
n=175 Participants
|
12 Participants
n=97 Participants
|
11 Participants
n=104 Participants
|
55 Participants
n=559 Participants
|
|
Exotropia control score
Near · XT >50% of 30-seconds
|
2 Participants
n=183 Participants
|
7 Participants
n=175 Participants
|
4 Participants
n=97 Participants
|
1 Participants
n=104 Participants
|
14 Participants
n=559 Participants
|
|
Exotropia control score
Near · Constant XT
|
1 Participants
n=183 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=104 Participants
|
1 Participants
n=559 Participants
|
|
Average Exotropia Control Score
Distance
|
2.4 scores on a scale
STANDARD_DEVIATION 1.2 • n=183 Participants
|
2.3 scores on a scale
STANDARD_DEVIATION 1.2 • n=175 Participants
|
2.5 scores on a scale
STANDARD_DEVIATION 1.2 • n=97 Participants
|
2.3 scores on a scale
STANDARD_DEVIATION 1.1 • n=104 Participants
|
2.4 scores on a scale
STANDARD_DEVIATION 1.2 • n=559 Participants
|
|
Average Exotropia Control Score
Near
|
1.1 scores on a scale
STANDARD_DEVIATION 1.0 • n=183 Participants
|
1.1 scores on a scale
STANDARD_DEVIATION 1.1 • n=175 Participants
|
1.2 scores on a scale
STANDARD_DEVIATION 1.2 • n=97 Participants
|
1.0 scores on a scale
STANDARD_DEVIATION 1.0 • n=104 Participants
|
1.1 scores on a scale
STANDARD_DEVIATION 1.1 • n=559 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Previously untreated children aged 3 to \<11 years. The 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
The primary outcome measure for this study was whether the participant's condition had deteriorated within 6 months after randomization. Deterioration was defined as meeting one or both of the following criteria during a masked examination at either the 3-month or 6-month visit: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.
Outcome measures
| Measure |
Older Cohort Observation Group
n=165 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
n=159 Participants
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Deterioration by 6 Months - Older Cohort
Formal deterioration criteria met
|
10 Participants
|
1 Participants
|
—
|
—
|
|
Deterioration by 6 Months - Older Cohort
Constant exotropia >= 10 PD at distance and near
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Deterioration by 6 Months - Older Cohort
Stereoacuity worsening of >= 2 octaves
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Deterioration by 6 Months - Older Cohort
Both criteria
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Deterioration by 6 Months - Older Cohort
Started treatment w/o meeting criteria
|
3 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. Because only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis.
The primary outcome measure for this study was whether the participant's condition had deteriorated within 3 years after randomization. Deterioration was defined as meeting one or both of the following criteria during any masked examination between 3 months and 3 years after randomization: 1) a constant exotropia (throughout the exam) of 10∆ or greater at distance and near by SPCT, confirmed by a retest, or 2) loss of near stereoacuity of 2 octaves (0.6 log arcsec) or more from the better of a test and retest of Preschool Randot stereoacuity at baseline, confirmed by a retest. In addition, participants were classified as deteriorated for the primary analysis if they started using non-randomized treatment (i.e., any treatment in the observation group; any treatment other than patching in the patching group) without first meeting one of the two protocol-specified deterioration criteria.
Outcome measures
| Measure |
Older Cohort Observation Group
n=183 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Deterioration by 3 Years - Older Cohort
|
25 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Previously untreated children aged 12 to 35 months. Motor deterioration was measured by simultaneous prism and cover test.
The primary outcome measure was deterioration of the intermittent exotropia (IXT) within 6 months after randomization. Motor deterioration was defined as a constant exotropia of 10 D or more at distance and near by SPCT, confirmed by a retest, at either the 3- or 6-month visit.
Outcome measures
| Measure |
Older Cohort Observation Group
n=87 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
n=90 Participants
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Deterioration by 6 Months - Younger Cohort
Deterioration
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Deterioration by 6 Months - Younger Cohort
Constant exotropia >= 10 PD at distance and near
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Deterioration by 6 Months - Younger Cohort
Started nonprotocol tmt w/o motor deterioration
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The younger cohort occlusion therapy group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
The primary outcome measure was deterioration of the intermittent exotropia (IXT) within 6 months after randomization. Motor deterioration was defined as a constant exotropia of 10 D or more at distance and near by SPCT, confirmed by a retest, during any masked examination between 3 months and 3 years after randomization.
Outcome measures
| Measure |
Older Cohort Observation Group
n=97 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Deterioration by 3 Years - Younger Cohort
|
24 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Between baseline and 3 yearsPopulation: Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation group, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at distance is reported at 3 years, as is the change in distance stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec. For change in stereo, positive change indicates improvement in stereo.
Outcome measures
| Measure |
Older Cohort Observation Group
n=132 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Distance Stereoacuity - 3 Years
At 3 Years
|
2.03 log arsec
Standard Deviation 0.36
|
—
|
—
|
—
|
|
Distance Stereoacuity - 3 Years
Change between baseline and 3 years
|
0.14 log arsec
Standard Deviation 0.40
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Stereoacuity data is missing for 2 observation group participants because it was not tested at the visit at which treatment was started in the absence of meeting deterioration criteria. The 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at near is reported at 3 years, as is the change in near stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec. Outcome based on initial testing regardless of whether a retest was completed for suspected deterioration. Change is calculated as baseline level minus 6-month level. For change in stereo, positive change indicates improvement in stereo.
Outcome measures
| Measure |
Older Cohort Observation Group
n=165 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
n=159 Participants
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Near Stereoacuity - 6 Months
At 6 months
|
1.84 log arsec
Standard Deviation 0.33
|
1.84 log arsec
Standard Deviation 0.31
|
—
|
—
|
|
Near Stereoacuity - 6 Months
Change between Baseline and 6 months
|
0.00 log arsec
Standard Deviation 0.32
|
0.06 log arsec
Standard Deviation 0.30
|
—
|
—
|
SECONDARY outcome
Timeframe: between baseline and 3 yearsPopulation: The older cohort occlusion therapy group was not reported on. The clinical trial ended after 6 months, after which the purpose of the study was to observe the natural history of patients in the Observation arm. No data were collected from participants from 6 months to 3 years, and there are no plans for analysis.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as log of seconds of arc, or log arcsec). The stereoacuity at near is reported at 3 years, as is the change in near stereoacuity from baseline to 3 years. Both were reported as log of seconds of arc, or log arcsec. For change in stereo, positive change indicates improvement in stereo.
Outcome measures
| Measure |
Older Cohort Observation Group
n=132 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Near Stereoacuity - 3 Years
At 3 Years
|
1.7 log arcsec
Standard Deviation 0.21
|
—
|
—
|
—
|
|
Near Stereoacuity - 3 Years
Change between Baseline and 3 Years
|
0.14 log arcsec
Standard Deviation 0.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change. Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Older Cohort Observation Group
n=165 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
n=159 Participants
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=87 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
n=90 Participants
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Exotropia Control at Distance - 6 Months
At 6 months
|
2.3 score on a scale
Standard Deviation 1.4
|
2.0 score on a scale
Standard Deviation 1.2
|
2.8 score on a scale
Standard Deviation 1.3
|
2.3 score on a scale
Standard Deviation 1.5
|
|
Exotropia Control at Distance - 6 Months
Change between Baseline and 6 months
|
0.1 score on a scale
Standard Deviation 1.4
|
0.3 score on a scale
Standard Deviation 1.4
|
-0.3 score on a scale
Standard Deviation 1.3
|
0.1 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change. Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Older Cohort Observation Group
n=132 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=53 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Exotropia Control at Distance - 3 Years
At 3 Years
|
1.8 score on a scale
Standard Deviation 1.4
|
—
|
2.2 score on a scale
Standard Deviation 1.5
|
—
|
|
Exotropia Control at Distance - 3 Years
Change between Baseline and 3 Years
|
0.6 score on a scale
Standard Deviation 1.5
|
—
|
0.2 score on a scale
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change. Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Older Cohort Observation Group
n=165 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
n=159 Participants
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=87 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
n=90 Participants
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Exotropia Control at Near - 6 Months
A 6 months
|
1.2 score on a scale
Standard Deviation 1.1
|
0.9 score on a scale
Standard Deviation 1.1
|
1.4 score on a scale
Standard Deviation 1.4
|
1.1 score on a scale
Standard Deviation 1.4
|
|
Exotropia Control at Near - 6 Months
Change between Baseline and 6 months
|
-0.2 score on a scale
Standard Deviation 1.1
|
0.1 score on a scale
Standard Deviation 1.1
|
-0.3 score on a scale
Standard Deviation 1.1
|
-0.1 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
Change in control is calculated as baseline level minus 3-year level, so positive change = improvement. Scale Range: 0 to 5. Improvement in control was defined as an improvement of 3 points based on the 3-point threshold for real change. Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Older Cohort Observation Group
n=132 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=53 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
Exotropia Control at Near - 3 Years
At 3 Years
|
0.9 score on a scale
Standard Deviation 1.1
|
—
|
1.0 score on a scale
Standard Deviation 1.4
|
—
|
|
Exotropia Control at Near - 3 Years
Change between Baseline and 3 Years
|
0.1 score on a scale
Standard Deviation 1.2
|
—
|
0.1 score on a scale
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time). log arcsec = logarithm of seconds of arc; Δ = prism diopter
Outcome measures
| Measure |
Older Cohort Observation Group
n=165 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
n=159 Participants
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=87 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
n=90 Participants
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
PACT Exodeviation at Distance - 6 Months
At 6 months
|
23.8 prism diopters
Standard Deviation 7.8
|
22.2 prism diopters
Standard Deviation 7.4
|
27.9 prism diopters
Standard Deviation 8.2
|
24.9 prism diopters
Standard Deviation 9.4
|
|
PACT Exodeviation at Distance - 6 Months
Change between Baseline and 6 months
|
-0.3 prism diopters
Standard Deviation 6.8
|
1.4 prism diopters
Standard Deviation 5.8
|
-0.6 prism diopters
Standard Deviation 8.1
|
2.0 prism diopters
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time). Improvement in PACT at distance was defined as a decrease of ≥8∆ because this amount exceed the repeatability coefficient of 7.2∆ for PACT angles larger than 20∆ at distance. log arcsec = logarithm of seconds of arc; Δ = prism diopter
Outcome measures
| Measure |
Older Cohort Observation Group
n=132 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=53 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
PACT at Distance - 3 Years
At 3 Years
|
21.0 prism diopters
Standard Deviation 8.7
|
—
|
23.4 prism diopters
Standard Deviation 9.5
|
—
|
|
PACT at Distance - 3 Years
Change between Baseline and 3 Years
|
2.2 prism diopters
Standard Deviation 8.3
|
—
|
3.6 prism diopters
Standard Deviation 10.4
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: For the Older Cohort, the 6-month primary outcome visit was completed by 165 participants (90%) in the observation group, and by 159 participants (91%) in the patching group.
The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time). log arcsec = logarithm of seconds of arc; Δ = prism diopter
Outcome measures
| Measure |
Older Cohort Observation Group
n=165 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
n=159 Participants
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=87 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
n=90 Participants
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
PACT at Near - 6 Months
At 6 months
|
17.6 prism diopters
Standard Deviation 9.6
|
15.4 prism diopters
Standard Deviation 10.1
|
19.3 prism diopters
Standard Deviation 9.6
|
17.0 prism diopters
Standard Deviation 12.2
|
|
PACT at Near - 6 Months
Change between Baseline and 6 months
|
0.5 prism diopters
Standard Deviation 7.8
|
1.5 prism diopters
Standard Deviation 8.0
|
-1.8 prism diopters
Standard Deviation 11.4
|
0.9 prism diopters
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Since only half the occlusion group underwent further occlusion between 6 months and 3 years, the long-term occlusion group data was not felt to be of value, and there are no plans for its analysis. For the observation groups, the number reported is those who completed the 3-Year visit and had not been prescribed treatment anytime during the study.
The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. For change in PACT, positive change indicates improvement (i.e. decrease in angle over time). Improvement in PACT at near was defined as a decrease of ≥13∆ because this amount exceed the repeatability coefficient of 12.8∆ for PACT angles larger than 20∆ at near. log arcsec = logarithm of seconds of arc; Δ = prism diopter
Outcome measures
| Measure |
Older Cohort Observation Group
n=132 Participants
Older cohort patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Older Cohort Occlusion Therapy Group
Occlusion treatment: older cohort patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
Younger Cohort Observation Group
n=53 Participants
Patients randomized to the observation group will receive no treatment (other than refractive correction).
|
Younger Cohort Occlusion Therapy Group
Occlusion treatment: Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.
|
|---|---|---|---|---|
|
PACT at Near - 3 Years
At 3 Years
|
17.0 prism diopters
Standard Deviation 10.1
|
—
|
14.9 prism diopters
Standard Deviation 10.3
|
—
|
|
PACT at Near - 3 Years
Change between Baseline and 3 Years
|
0.4 prism diopters
Standard Deviation 9.3
|
—
|
2.8 prism diopters
Standard Deviation 12.0
|
—
|
Adverse Events
Older Cohort Observation Group
Older Cohort Occlusion Therapy Group
Younger Cohort Observation Group
Younger Cohort Occlusion Therapy Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place