Trial · NCT00944710
Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
NCT00944710, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2014-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old. Trials, record NCT00944710. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00944710
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
- NCT number
- NCT00944710
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 73 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Amblyopia
- Interventions
- Atropine, Plano lens, Atropine
- First posted
- 2009-07-23
- Last updated
- 2019-03-06
- Results first posted
- 2014-10-24
- Limitations and caveats
A potential study limitation is that compliance with patching was based on discussions with the parent and by reviewing study calendars maintained by the parent, which not an objective measure of compliance.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Distribution of 10-week Amblyopic-Eye Visual Acuity | 10 weeks after randomization | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | participants | NUMBER |
| 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 analysis includes data from participants who completed a 10-week exam. | participants | NUMBER |
| 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 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 | NUMBER |
| SECONDARY | Spectacle Compliance at 10 Weeks by Treatment Group | 10 weeks after randomization | participants | NUMBER | |
| 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) | participants | NUMBER | |
| SECONDARY | Atropine Compliance at 10 Weeks by Treatment Group | 10 weeks after randomization | participants | NUMBER | |
| 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) | participants | NUMBER | |
| PRIMARY | Mean 10-week Amblyopic-Eye Visual Acuity | 10 weeks after randomization | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | logMAR | MEAN |
| PRIMARY | Distribution of the Change in Amblyopic-Eye Visual Acuity | Randomization to 10 weeks | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | participants | NUMBER |
| PRIMARY | Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization | Randomization to 10 weeks | The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data. | logMAR lines | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group338
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Control | 20/200 | 0 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Intensified Treatment | 20/200 | 1 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Control | 20/160 | 2 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Intensified Treatment | 20/160 | 0 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Control | 20/125 | 1 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Intensified Treatment | 20/125 | 2 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Control | 20/100 | 4 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Intensified Treatment | 20/100 | 0 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Control | 20/80 | 5 | participants | |
| Distribution of 10-week Amblyopic-Eye Visual Acuity | Intensified Treatment | 20/80 | 4 | participants |
1 to 10 of 338Source ClinicalTrials.gov
See all 338 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 10-week Primary Outcome | STARTED | Control | 40 | |
| 10-week Primary Outcome | STARTED | Intensified Treatment | 33 | |
| 10-week Primary Outcome | COMPLETED | Control | 40 | |
| 10-week Primary Outcome | COMPLETED | Intensified Treatment | 33 | |
| 10-week Primary Outcome | NOT COMPLETED | Control | 0 | |
| 10-week Primary Outcome | NOT COMPLETED | Intensified Treatment | 0 | |
| 12-week Visit (Off-treatment) | STARTED | Control | 40 | |
| 12-week Visit (Off-treatment) | STARTED | Intensified Treatment | 33 | |
| 12-week Visit (Off-treatment) | COMPLETED | Control | 40 | |
| 12-week Visit (Off-treatment) | COMPLETED | Intensified Treatment | 33 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Light Sensitivity | Eye disorders | Control | 1 | 40 | |
| other | Light Sensitivity | Eye disorders | Intensified Treatment | 6 | 33 | |
| other | New ocular deviation or worsening of preexisting deviation by at least 10 PD | Eye disorders | Control | 4 | 40 | |
| other | New ocular deviation or worsening of preexisting deviation by at least 10 PD | Eye disorders | Intensified Treatment | 3 | 33 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | ||
| Total, all-cause mortality | Intensified Treatment | ||
| Total, other adverse events | Control | 5 | 40 |
| Total, other adverse events | Intensified Treatment | 9 | 33 |
| Total, serious adverse events | Control | 0 | 40 |
| Total, serious adverse events | Intensified Treatment | 0 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25727586 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10EY011751 | Pediatric Eye Disease Investigator Group Coordinating Center | KRAKER, RAYMOND | JAEB CENTER FOR HEALTH RESEARCH, INC. | NATIONAL EYE INSTITUTE | 1997 to 2018 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intensified Treatment vs Control: Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization | Trial comparisons |
| Intensified Treatment vs Control: Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization | Trial comparisons |
| Intensified Treatment vs Control: 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 | Trial comparisons |
| Intensified Treatment vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00944710
GET https://conductscience.org/api/trials/v1/NCT00944710/registered?page=2