Trial · NCT00315328
Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds
NCT00315328, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2011-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds. Trials, record NCT00315328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00315328
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds
- NCT number
- NCT00315328
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 233 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Amblyopia
- Interventions
- Atropine, Patching, Near activities
- First posted
- 2006-04-18
- Last updated
- 2016-06-24
- Results first posted
- 2011-06-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 17 weeks | Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. |
| Primary | Mean Visual Acuity in the Amblyopic Eye at 17 Weeks | 17 weeks | Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. |
| Primary | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | Baseline to 17 weeks | Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks. |
| Primary | Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | Baseline to 17 weeks | Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks. |
| Secondary | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 17 or 19 weeks | The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes. |
| Secondary | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 17 or 19 weeks | The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes. |
| Secondary | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 17 or 19 weeks | The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes. |
| Secondary | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 17 or 19 weeks | Stereoacuity is scored as seconds of arc with values of: \<800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; \<800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as "within one level" meaning change was -1, 0, or +1. |
| Secondary | Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) | 17 weeks | Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response. |
| Secondary | Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) | 17 weeks | Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 17 or 19 weeks | Participants | NUMBER | |
| SECONDARY | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only | 17 or 19 weeks | Participants | NUMBER | |
| SECONDARY | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 17 or 19 weeks | Participants | NUMBER | |
| SECONDARY | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 17 or 19 weeks | Participants | NUMBER | |
| SECONDARY | Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) | 17 weeks | Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family. | Units on a scale | MEAN |
| SECONDARY | Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) | 17 weeks | Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family. | Units on a scale | MEAN |
| SECONDARY | Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only) | 17 weeks | Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family. | Units on a scale | MEAN |
| PRIMARY | Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks | 17 weeks | Primary analysis includes only patients who completed the 17 week exam between 13 and 26 weeks following randomization. No imputation was done if missed exam; analysis followed the intent to treat principle. | participants | NUMBER |
| PRIMARY | Mean Visual Acuity in the Amblyopic Eye at 17 Weeks | 17 weeks | ETDRS letter score | MEAN | |
| PRIMARY | Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks | Baseline to 17 weeks | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group212
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Patching-Moderate Amblyopia | Failed black & white shape identification pretest | 1 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Atropine-Moderate Amblyopia | Failed black & white shape identification pretest | 4 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Patching-Moderate Amblyopia | >800 arcsec (worse) | 26 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Atropine-Moderate Amblyopia | >800 arcsec (worse) | 34 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Patching-Moderate Amblyopia | 800 arcsec | 9 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Atropine-Moderate Amblyopia | 800 arcsec | 3 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Patching-Moderate Amblyopia | 400 arcsec | 9 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Atropine-Moderate Amblyopia | 400 arcsec | 14 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Patching-Moderate Amblyopia | 200 arcsec | 10 | Participants | |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | Atropine-Moderate Amblyopia | 200 arcsec | 10 | Participants |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patching-Moderate Amblyopia | 98 | |
| Overall Study | STARTED | Atropine-Moderate Amblyopia | 95 | |
| Overall Study | STARTED | Patching-Severe Amblyopia | 18 | |
| Overall Study | STARTED | Atropine-Severe Amblyopia | 22 | |
| Overall Study | 5 Week Visit | Patching-Moderate Amblyopia | 91 | |
| Overall Study | 5 Week Visit | Atropine-Moderate Amblyopia | 89 | |
| Overall Study | 5 Week Visit | Patching-Severe Amblyopia | 17 | |
| Overall Study | 5 Week Visit | Atropine-Severe Amblyopia | 19 | |
| Overall Study | COMPLETED | Patching-Moderate Amblyopia | 84 | |
| Overall Study | COMPLETED | Atropine-Moderate Amblyopia | 88 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events8
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 | Patching-Moderate Amblyopia | 0 | 98 | |
| other | Light sensitivity | Eye disorders | Atropine-Moderate Amblyopia | 14 | 95 | |
| other | Light sensitivity | Eye disorders | Patching-Severe Amblyopia | 0 | 18 | |
| other | Light sensitivity | Eye disorders | Atropine-Severe Amblyopia | 3 | 22 | |
| other | Systemic | General disorders | Patching-Moderate Amblyopia | 0 | 98 | |
| other | Systemic | General disorders | Atropine-Moderate Amblyopia | 0 | 95 | |
| other | Systemic | General disorders | Patching-Severe Amblyopia | 0 | 18 | |
| other | Systemic | General disorders | Atropine-Severe Amblyopia | 2 | 22 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patching-Moderate Amblyopia | ||
| Total, all-cause mortality | Atropine-Moderate Amblyopia | ||
| Total, all-cause mortality | Patching-Severe Amblyopia | ||
| Total, all-cause mortality | Atropine-Severe Amblyopia | ||
| Total, other adverse events | Patching-Moderate Amblyopia | 0 | 98 |
| Total, other adverse events | Atropine-Moderate Amblyopia | 14 | 95 |
| Total, other adverse events | Patching-Severe Amblyopia | 0 | 18 |
| Total, other adverse events | Atropine-Severe Amblyopia | 5 | 22 |
| Total, serious adverse events | Patching-Moderate Amblyopia | 0 | 98 |
| Total, serious adverse events | Atropine-Moderate Amblyopia | 0 | 95 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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