Trial Outcomes & Findings for Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old (NCT NCT00669539)
NCT ID: NCT00669539
Last Updated: 2016-07-13
Results Overview
Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Recruitment status
COMPLETED
Target enrollment
156 participants
Primary outcome timeframe
Enrollment to 18 Weeks
Results posted on
2016-07-13
Participant Flow
Participant milestones
| Measure |
Combined-Mechanism Amblyopia
Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
|
Strabismus-Only Amblyopia
Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
52
|
|
Overall Study
COMPLETED
|
86
|
43
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old
Baseline characteristics by cohort
| Measure |
Combined-Mechanism Amblyopia
n=94 Participants
Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
|
Strabismus-Only Amblyopia
n=52 Participants
Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.1 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
4.7 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
4.9 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Age, Customized
3 to <4 years
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Age, Customized
4 to <5 years
|
35 participants
n=5 Participants
|
16 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Age, Customized
5 to <6 years
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Age, Customized
6 to <7 years
|
26 participants
n=5 Participants
|
5 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/Aftican American
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
82 participants
n=5 Participants
|
37 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Distance Visual Acuity Amblyopic Eye
|
0.64 logMAR
STANDARD_DEVIATION 0.24 • n=5 Participants
|
0.65 logMAR
STANDARD_DEVIATION 0.26 • n=7 Participants
|
0.64 logMAR
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
Distance Visual Acuity in Fellow Eye
|
0.09 logMAR
STANDARD_DEVIATION 0.12 • n=5 Participants
|
0.16 logMAR
STANDARD_DEVIATION 0.11 • n=7 Participants
|
0.12 logMAR
STANDARD_DEVIATION 0.12 • n=5 Participants
|
|
Interocular Difference in Distance Visual Acuity
|
5.4 logMAR lines
STANDARD_DEVIATION 2.4 • n=5 Participants
|
4.9 logMAR lines
STANDARD_DEVIATION 2.2 • n=7 Participants
|
5.2 logMAR lines
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye
0 to <+1.00 diopters (better)
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye
+1.00 to <+2.00 diopters
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye
+2.00 to <+3.00 diopters
|
5 participants
n=5 Participants
|
17 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye
+3.00 to <+4.00 diopters
|
17 participants
n=5 Participants
|
10 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye
>=+4.00 diopters (worse)
|
63 participants
n=5 Participants
|
21 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Amblyopic Eye
|
4.65 diopters
STANDARD_DEVIATION 1.79 • n=5 Participants
|
3.69 diopters
STANDARD_DEVIATION 1.74 • n=7 Participants
|
4.31 diopters
STANDARD_DEVIATION 1.83 • n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye
0 to <+1.00 diopters (better)
|
11 participants
n=5 Participants
|
1 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye
+1.00 to <+2.00 diopters
|
24 participants
n=5 Participants
|
5 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye
+2.00 to <+3.00 diopters
|
32 participants
n=5 Participants
|
17 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye
+3.00 to <+4.00 diopters
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye
>=+4.00 diopters (worse)
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Spherical Equivalent Refractive Error in Fellow Eye
|
2.61 diopters
STANDARD_DEVIATION 1.60 • n=5 Participants
|
3.44 diopters
STANDARD_DEVIATION 1.62 • n=7 Participants
|
2.90 diopters
STANDARD_DEVIATION 1.65 • n=5 Participants
|
|
Ocular Alignment
0 prism diopters (better)
|
23 participants
n=5 Participants
|
14 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Ocular Alignment
1-8 prism diopters
|
48 participants
n=5 Participants
|
15 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Ocular Alignment
>8 prism diopters (worse)
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Ocular Alignment
|
5.7 prism diopters
STANDARD_DEVIATION 7.0 • n=5 Participants
|
11.1 prism diopters
STANDARD_DEVIATION 14.5 • n=7 Participants
|
7.6 prism diopters
STANDARD_DEVIATION 10.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment to 18 WeeksPopulation: Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.
Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
Outcome measures
| Measure |
Combined-Mechanism Amblyopia
n=86 Participants
Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
|
Strabismus-Only Amblyopia
n=43 Participants
Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
|
|---|---|---|
|
Mean Amblyopic Eye Visual Acuity Improvement With Spectacles
|
2.3 logMAR units
Standard Deviation 1.8
|
3.2 logMAR units
Standard Deviation 1.9
|
Adverse Events
Combined-Mechanism Amblyopia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Strabismus-Only Amblyopia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place