Trial · NCT00944710
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Distribution of 10-week Amblyopic-Eye Visual Acuity | 10 weeks after randomization | 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. |
| Primary | Mean 10-week Amblyopic-Eye Visual Acuity | 10 weeks after randomization | 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. |
| Primary | Distribution of the Change in Amblyopic-Eye Visual Acuity | Randomization to 10 weeks | 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. |
| Primary | Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization | Randomization to 10 weeks | 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. |
| Secondary | Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization | 10 weeks after 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. |
| Secondary | Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization | 10 weeks after 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. |
| Secondary | Spectacle Compliance at 10 Weeks by Treatment Group | 10 weeks after randomization | 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. |
| Secondary | Average Spectacle Compliance by Treatment Group | 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) | 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. |
| Secondary | Atropine Compliance at 10 Weeks by Treatment Group | 10 weeks after randomization | 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. |
| Secondary | Average Atropine Compliance by Treatment Group | 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) | 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. |
| Secondary | Distribution of Interocular Difference at 12-week Exam | 12 weeks after randomization | Distribution of Interocular Difference Between Eyes at 12-week Exam |
| Secondary | Mean Interocular Difference at 12-week Exam | 12 weeks after randomization | Mean Interocular Difference Between Eyes at 12-week Exam |
| Secondary | Distribution of 12-week Fellow-Eye Visual Acuity | 12 weeks after randomization | 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. |
| Secondary | Mean Fellow-Eye Visual Acuity at 12-week Exam | 12 weeks after randomization | |
| Secondary | Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization | 12 weeks after randomization | |
| Secondary | Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization | 12 weeks after randomization | |
| Secondary | Distribution of Baseline Characteristics at the 10-week Outcome | 10 weeks after randomization | 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. |
| Secondary | Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome | 10 weeks after randomization | 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. |
| Secondary | Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics | 10 weeks after randomization | 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. |
| Secondary | Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit | 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject) | 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.) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT00944710/registered