A Phase 3 interventional study of Atropine and Plano lens in Amblyopia, sponsored by Jaeb Center for Health Research. Completed at 2 sites in United States. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by Jaeb Center for Health Research · Phase 3, Interventional, and Treatment
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children.1 Many practitioners prescribe weekend atropine as initial therapy for amblyopia. However, many children fail to achieve normal visual acuity in the amblyopic eye after treatment with this regimen. In a randomized trial conducted by PEDIG comparing atropine regimens, 58 of 83 patients with moderate amblyopia (70%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of treatment with weekend atropine.2 In another PEDIG randomized trial comparing atropine with a plano lens versus without a plano lens for initial treatment of amblyopia, 60 of 84 patients with moderate amblyopia (71%) had amblyopic eye visual acuity of 20/32 or worse after 16 weeks of treatment with weekend atropine.3 When improvement stops after initial therapy and amblyopia is still present, treatment options include increasing the dosage of current treatment, switching to another treatment, maintaining the same treatment and dosage, or combining treatments. Many clinicians will add a plano lens over the sound eye to atropine treatment, in part because families using atropine have become comfortable with its use. This option is limited to children with hypermetropia in the sound eye. However, it is unknown whether adding a plano lens over the sound eye will improve amblyopic eye visual acuity more than continuing atropine alone in patients who have shown no improvement after initial treatment with atropine. In a PEDIG randomized trial comparing patching to atropine for initial treatment of amblyopia, a plano lens was prescribed for the sound eye for 55 patients who had not improved to 20/30 or at least 3 lines after 4 months of daily atropine use.1, 4 Their mean acuity improvement prior to using the plano lens was 1.0 line, compared with 1.6 lines after prescribing the plano lens. We are unaware of any reports of the response of treatment of amblyopia still present after initial treatment with weekend atropine.
183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.
This study's enrollment of 73 is above the median of 60 across 133 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
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Major Eligibility Criteria for Run-in Phase
Amblyopia treatment within the past 6 months subject to the following stipulations:
Maximum level of treatment within the past 6 months:
Eligibility Criteria for Randomization:
Exclusion Criteria:
Weekend atropine 1% with plano lens over the sound eye
Drug: Atropine · Device: Plano lens
Weekend atropine 1%
Drug: Atropine
Weekend atropine 1%
plano lens over the sound eye
Weekend atropine 1%
Distribution of 10-week Amblyopic-Eye Visual Acuity
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Time frame: 10 weeks after randomization
Mean 10-week Amblyopic-Eye Visual Acuity
The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Time frame: 10 weeks after randomization
Distribution of the Change in Amblyopic-Eye Visual Acuity
The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Time frame: Randomization to 10 weeks
Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization
The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Time frame: Randomization to 10 weeks
Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization
The proportion of participants who achieved 20/25 or better visual acuity since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity was 20/25 or better since randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Time frame: 10 weeks after randomization
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Time frame: 10 weeks after randomization
Spectacle Compliance at 10 Weeks by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
Time frame: 10 weeks after randomization
Average Spectacle Compliance by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Atropine Compliance at 10 Weeks by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
Time frame: 10 weeks after randomization
Average Atropine Compliance by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Interocular Difference at 12-week Exam
Distribution of Interocular Difference Between Eyes at 12-week Exam
Time frame: 12 weeks after randomization
Mean Interocular Difference at 12-week Exam
Mean Interocular Difference Between Eyes at 12-week Exam
Time frame: 12 weeks after randomization
Distribution of 12-week Fellow-Eye Visual Acuity
Following the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.
Time frame: 12 weeks after randomization
Mean Fellow-Eye Visual Acuity at 12-week Exam
Time frame: 12 weeks after randomization
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
Time frame: 12 weeks after randomization
Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
Time frame: 12 weeks after randomization
Distribution of Baseline Characteristics at the 10-week Outcome
The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to principles specified in the primary outcome analysis.
Time frame: 10 weeks after randomization
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Time frame: 10 weeks after randomization
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Time frame: 10 weeks after randomization
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Time frame: Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of \>800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.
Time frame: 12 weeks after randomization
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
Time frame: 12 weeks after randomization
Between November 2009 and August 2013, 73 participants from 20 sites were randomly assigned to either augmenting weekend atropine by changing the lens over the fellow eye to plano (n=33) or continuing with weekend atropine with best spectacle correction (n=40).
| Milestone | Control | Intensified Treatment |
|---|---|---|
| Started | 40 | 33 |
| Completed | 40 | 33 |
| Not completed | 0 | 0 |
| Milestone | Control | Intensified Treatment |
|---|---|---|
| Started | 40 | 33 |
| Completed | 40 | 33 |
| Not completed | 0 | 0 |
| Milestone | Control | Intensified Treatment |
|---|---|---|
| Started | 40 | 33 |
| Eligible to enter post 10-week phase | 24 | 26 |
| Completed | 23 | 22 |
| Not completed | 17 | 11 |
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
| participants | Control | Intensified Treatment |
|---|---|---|
| 20/200 | 0 | 1 |
| 20/160 | 2 | 0 |
| 20/125 | 1 | 2 |
| 20/100 | 4 | 0 |
| 20/80 | 5 | 4 |
| 20/63 | 3 | 4 |
| 20/50 | 6 | 6 |
| 20/40 | 11 | 4 |
| 20/32 | 3 | 6 |
| 20/25 | 3 | 5 |
| 20/20 | 1 | 1 |
| 20/16 | 0 | 0 |
The proportion of participants who achieved 20/25 or better visual acuity since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity was 20/25 or better since randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
| participants | Control | Intensified Treatment |
|---|---|---|
| Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization | 4 | 6 |
The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
| participants | Control | Intensified Treatment |
|---|---|---|
| Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization | 8 | 9 |
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
| participants | Control | Intensified Treatment |
|---|---|---|
| Excellent | 39 | 30 |
| Good | 1 | 1 |
| Fair | 0 | 1 |
| Poor | 0 | 1 |
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
| participants | Control | Intensified Treatment |
|---|---|---|
| Excellent | 39 | 30 |
| Good | 1 | 2 |
| Fair | 0 | 0 |
| Poor | 0 | 1 |
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
| participants | Control | Intensified Treatment |
|---|---|---|
| Excellent | 38 | 31 |
| Good | 2 | 2 |
| Fair | 0 | 0 |
| Poor | 0 | 0 |
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (\>75%), good (51%-75%), fair (26%-50%), or poor (\<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
| participants | Control | Intensified Treatment |
|---|---|---|
| Excellent | 39 | 29 |
| Good | 1 | 4 |
| Fair | 0 | 0 |
| Poor | 0 | 0 |
The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
| logMAR | Control | Intensified Treatment |
|---|---|---|
| Mean 10-week Amblyopic-Eye Visual Acuity | 0.42 ± 0.22 | 0.37 ± 0.23 |
The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
| participants | Control | Intensified Treatment |
|---|---|---|
| 3 or more lines worse | 0 | 0 |
| 2 lines worse | 1 | 2 |
| 1 line worse | 4 | 3 |
| No change | 14 | 6 |
| 1 line improved | 12 | 13 |
| 2 lines improved | 7 | 2 |
| 3 or more lines improved | 1 | 7 |
The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
| logMAR lines | Control | Intensified Treatment |
|---|---|---|
| Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization | 0.6 ± 1.1 | 1.1 ± 1.8 |
Distribution of Interocular Difference Between Eyes at 12-week Exam
| participants | Control | Intensified Treatment |
|---|---|---|
| 0 or less lines | 3 | 2 |
| 1 line | 2 | 2 |
| 2 lines | 6 | 8 |
| 3 lines | 6 | 8 |
| 4 lines | 5 | 4 |
| 5 lines | 5 | 5 |
| 6 or more lines | 12 | 4 |
Mean Interocular Difference Between Eyes at 12-week Exam
| logMAR lines | Control | Intensified Treatment |
|---|---|---|
| Mean Interocular Difference at 12-week Exam | 4.3 ± 2.6 | 3.3 ± 2.0 |
Following the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.
| participants | Control | Intensified Treatment |
|---|---|---|
| 20/40 | 1 | 0 |
| 20/32 | 0 | 4 |
| 20/25 | 10 | 7 |
| 20/20 | 19 | 14 |
| 20/16 | 10 | 8 |
| logMAR | Control | Intensified Treatment |
|---|---|---|
| Mean Fellow-Eye Visual Acuity at 12-week Exam | 0.01 ± 0.09 | 0.02 ± 0.10 |
| participants | Control | Intensified Treatment |
|---|---|---|
| 3 or more lines worse | 1 | 0 |
| 2 lines worse | 0 | 0 |
| 1 line worse | 1 | 2 |
| No change | 23 | 22 |
| 1 line improved | 12 | 7 |
| 2 lines improved | 3 | 2 |
| 3 or more lines improved | 0 | 0 |
| change in lines | Control | Intensified Treatment |
|---|---|---|
| Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization | 0.4 ± 0.9 | 0.3 ± 0.7 |
The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to principles specified in the primary outcome analysis.
| participants | Control | Intensified Treatment |
|---|---|---|
| Gender: Female | 21 | 19 |
| Gender: Male | 18 | 14 |
| Race/Ethnicity: White (non-Hispanic) | 32 | 29 |
| Race/Ethnicity: Non-White/Hispanic | 7 | 4 |
| Age at randomization: 3 to <4 years | 5 | 4 |
| Age at randomization: 4 to <5 years | 7 | 6 |
| Age at randomization: 5 to <6 years | 9 | 9 |
| Age at randomization: 6 to <7 years | 7 | 5 |
| Age at randomization: 7 years or older | 11 | 9 |
| Amblyopic-eye VA at randomization: 20/80 or worse | 11 | 10 |
| Amblyopic-eye VA at randomization: 20/63 | 9 | 8 |
| Amblyopic-eye VA at randomization: 20/50 | 7 | 8 |
| Amblyopic-eye VA at randomization: 20/40 or better | 12 | 7 |
| Cause of amblyopia: Strabismus | 8 | 13 |
| Cause of amblyopia: Anisometropia | 10 | 6 |
| Cause of amblyopia: Combined mechanism | 21 | 14 |
| Atropine duration prior to randomization:12-<15wks | 11 | 5 |
| Atropine duration prior to randomization:15-<21wks | 6 | 9 |
| Atropine duration prior to randomization:21-<27wks | 12 | 9 |
| Atropine duration prior to randomization:27-84 wks | 10 | 10 |
| Fellow-eye SE RE at enrollment: <+3.00 Diopters(D) | 10 | 7 |
| Fellow-eye SE RE at enrollment: +3.00 to <+4.50 D | 12 | 13 |
| Fellow-eye SE RE at enrollment: +4.50 to +6.00 D | 12 | 4 |
| Fellow-eye SE RE at enrollment: >+6.00 D | 5 | 9 |
Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
| logMAR | Control | Intensified Treatment |
|---|---|---|
| Gender: Female | 0.51 ± 0.19 | 0.46 ± 0.14 |
| Gender: Male | 0.45 ± 0.19 | 0.51 ± 0.19 |
| Race/Ethnicity: White (non-Hispanic) | 0.50 ± 0.19 | 0.49 ± 0.17 |
| Race/Ethnicity: Non-White/Hispanic | 0.41 ± 0.18 | 0.43 ± 0.05 |
| Age at randomization: 3 to <4 years | 0.58 ± 0.22 | 0.48 ± 0.17 |
| Age at randomization: 4 to <5 years | 0.50 ± 0.13 | 0.58 ± 0.23 |
| Age at randomization: 5 to <6 years | 0.46 ± 0.21 | 0.42 ± 0.10 |
| Age at randomization: 6 to <7 years | 0.43 ± 0.18 | 0.50 ± 0.12 |
| Age at randomization: 7 years or older | 0.48 ± 0.21 | 0.48 ± 0.18 |
| Cause of amblyopia: Strabismus | 0.48 ± 0.23 | 0.46 ± 0.16 |
| Cause of amblyopia: Anisometropia | 0.42 ± 0.13 | 0.35 ± 0.11 |
| Cause of amblyopia: Combined mechanism | 0.51 ± 0.20 | 0.56 ± 0.15 |
| Atropine duration prior to randomization:12-<15wks | 0.54 ± 0.23 | 0.38 ± 0.11 |
| Atropine duration prior to randomization:15-<21wks | 0.53 ± 0.23 | 0.51 ± 0.18 |
| Atropine duration prior to randomization:21-<27wks | 0.43 ± 0.12 | 0.53 ± 0.12 |
| Atropine duration prior to randomization:27-84 wks | 0.46 ± 0.18 | 0.47 ± 0.19 |
| Fellow-eye SE RE at enrollment: <+3.00 Diopters(D) | 0.41 ± 0.20 | 0.49 ± 0.20 |
| Fellow-eye SE RE at enrollment: +3.00 to <+4.50 D | 0.50 ± 0.18 | 0.51 ± 0.16 |
| Fellow-eye SE RE at enrollment: +4.50 to +6.00 D | 0.53 ± 0.17 | 0.45 ± 0.24 |
| Fellow-eye SE RE at enrollment: >+6.00 D | 0.48 ± 0.25 | 0.47 ± 0.11 |
A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
| logMAR lines | Control | Intensified Treatment |
|---|---|---|
| Gender: Female | 0.2 ± 1.0 | 1.2 ± 1.6 |
| Gender: Male | 1.0 ± 1.0 | 1.1 ± 2.0 |
| Race/Ethnicity: White (non-Hispanic) | 0.5 ± 1.1 | 1.1 ± 1.8 |
| Race/Ethnicity: Non-White/Hispanic | 0.9 ± 1.2 | 1.0 ± 2.2 |
| Age at randomization: 3 to <4 years | 0.2 ± 0.8 | 1.3 ± 1.3 |
| Age at randomization: 4 to <5 years | 04 ± 1.5 | 0.7 ± 2.4 |
| Age at randomization: 5 to <6 years | 0.8 ± 1.3 | 1.2 ± 1.4 |
| Age at randomization: 6 to <7 years | 0.3 ± 0.5 | 2.4 ± 2.0 |
| Age at randomization: 7 years or older | 0.9 ± 0.9 | 0.6 ± 1.7 |
| Amblyopic-eye VA at randomization: 20/80 or worse | 0.5 ± 0.7 | 1.0 ± 2.4 |
| Amblyopic-eye VA at randomization: 20/63 | 0.4 ± 1.3 | 1.5 ± 1.7 |
| Amblyopic-eye VA at randomization: 20/50 | 1.0 ± 1.3 | 1.3 ± 1.7 |
| Amblyopic-eye VA at randomization: 20/40 or better | 0.5 ± 1.1 | 0.7 ± 1.0 |
| Cause of amblyopia: Strabismus | 0.1 ± 1.1 | 1.7 ± 1.8 |
| Cause of amblyopia: Anisometropia | 0.8 ± 0.9 | 1.0 ± 1.9 |
| Cause of amblyopia: Combined mechanism | 0.7 ± 1.1 | 0.6 ± 1.6 |
| Atropine duration prior to randomization:12-<15wks | 1.1 ± 0.7 | 1.2 ± 1.8 |
| Atropine duration prior to randomization:15-<21wks | -0.3 ± 1.0 | 1.7 ± 2.2 |
| Atropine duration prior to randomization:21-<27wks | 0.6 ± 1.3 | 1.2 ± 1.5 |
| Atropine duration prior to randomization:27-84 wks | 0.6 ± 0.8 | 0.5 ± 1.6 |
| Fellow-eye SE RE at enrollment: <+3.00 Diopters(D) | 0.7 ± 1.3 | 1.0 ± 2.7 |
| Fellow-eye SE RE at enrollment: +3.00 to <+4.50 D | 0.7 ± 1.2 | 1.0 ± 1.2 |
| Fellow-eye SE RE at enrollment: +4.50 to +6.00 D | 0.4 ± 0.9 | 1.3 ± 2.6 |
| Fellow-eye SE RE at enrollment: >+6.00 D | 0.6 ± 1.1 | 1.3 ± 1.4 |
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
| participants | Control | Intensified Treatment |
|---|---|---|
| 20/200 | 0 | 1 |
| 20/160 | 2 | 0 |
| 20/125 | 1 | 0 |
| 20/100 | 3 | 1 |
| 20/80 | 6 | 1 |
| 20/63 | 1 | 4 |
| 20/50 | 8 | 5 |
| 20/40 | 10 | 3 |
| 20/32 | 3 | 10 |
| 20/25 | 5 | 5 |
| 20/20 | 1 | 3 |
| 20/16 | 0 | 0 |
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.
| logMAR | Control | Intensified Treatment |
|---|---|---|
| Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit | 0.40 ± 0.23 | 0.29 ± 0.22 |
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
| participants | Control | Intensified Treatment |
|---|---|---|
| 3 or more lines worse | 0 | 0 |
| 2 lines worse | 1 | 1 |
| 1 line worse | 4 | 3 |
| No change | 12 | 3 |
| 1 line improved | 12 | 6 |
| 2 lines improved | 9 | 6 |
| 3 or more lines improved | 2 | 14 |
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)
| logMAR lines | Control | Intensified Treatment |
|---|---|---|
| Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit | 0.8 ± 1.2 | 1.9 ± 1.8 |
| participants | Control | Intensified Treatment |
|---|---|---|
| Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit | 11 | 20 |
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of \>800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.
| participants | Control | Intensified Treatment |
|---|---|---|
| Failed pretest | 4 | 2 |
| >800 arcsec: Nil | 7 | 10 |
| >800 arcsec: 3000 arcsec | 14 | 12 |
| 800 arcsec | 7 | 3 |
| 400 arcsec | 4 | 3 |
| 200 arcsec | 0 | 1 |
| 100 arcsec | 1 | 1 |
| 60 arcsec | 2 | 1 |
| 40 arcsec | 1 | 0 |
| participants | Control | Intensified Treatment |
|---|---|---|
| Failed pretest | 0 | 0 |
| >800 arcsec: Nil | 1 | 1 |
| >800 arcsec: 3000 arcsec | 2 | 2 |
| 800 arcsec | 3 | 1 |
| 400 arcsec | 2 | 0 |
| 200 arcsec | 0 | 0 |
| 100 arcsec | 0 | 1 |
| 60 arcsec | 1 | 1 |
| 40 arcsec | 1 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/40 (0%) | 5/40 (12.5%) |
| Intensified Treatment | — | 0/33 (0%) | 9/33 (27.3%) |
| Event | Control | Intensified Treatment |
|---|---|---|
| Light SensitivityEye disorders | 1/40 | 6/33 |
| New ocular deviation or worsening of preexisting deviation by at least 10 PDEye disorders | 4/40 | 3/33 |
| Age, Categorical(Participants) | Control | Intensified Treatment | Total |
|---|---|---|---|
| <=18 years | 40 | 33 | 73 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control | Intensified Treatment | Total |
|---|---|---|---|
| Mean | 5.8 ± 1.5 | 5.8 ± 1.4 | 5.8 ± 1.4 |
| Age, Customized(participants) | Control | Intensified Treatment | Total |
|---|---|---|---|
| 3 to <4 years | 5 | 4 | 9 |
| 4 to <5 years | 8 | 6 | 14 |
| 5 to <6 years | 9 | 9 | 18 |
| 6 to <7 years | 7 | 5 | 12 |
| >=7 years | 11 | 9 | 20 |
| Sex: Female, Male(Participants) | Control | Intensified Treatment | Total |
|---|---|---|---|
| Female | 22 | 19 | 41 |
| Male | 18 | 14 | 32 |
| Race/Ethnicity, Customized(participants) | Control | Intensified Treatment | Total |
|---|---|---|---|
| White | 33 | 29 | 62 |
| African American | 3 | 1 | 4 |
| Hispanic | 4 | 3 | 7 |
| Region of Enrollment(participants) | Control | Intensified Treatment | Total |
|---|---|---|---|
| United States | 40 | 33 | 73 |
| Duration of Atropine Treatment Prior to Randomization(participants) | Control | Intensified Treatment | Total |
|---|---|---|---|
| 12 to <15 weeks | 11 | 5 | 16 |
| 15 to <21 weeks | 6 | 9 | 15 |
| 21 to <27 weeks | 13 | 9 | 22 |
| 27 to 84 weeks | 10 | 10 | 20 |
| Duration of Atropine Treatment Prior to Randomization(weeks) | Control | Intensified Treatment | Total |
|---|---|---|---|
| Mean | 24.0 ± 11.2 | 26.4 ± 14.6 | 25.0 ± 12.8 |
10 further baseline measures are reported on the registry.
Plan to share: Yes — In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website at http://pedig.jaeb.org/Studies.aspx?RecID=30
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