Trial · NCT00315302
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
NCT00315302, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2011-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old. Trials, record NCT00315302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00315302
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
- NCT number
- NCT00315302
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 240 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Amblyopia
- Interventions
- Atropine, Plano Lens
- First posted
- 2006-04-18
- Last updated
- 2016-07-19
- Results first posted
- 2011-08-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Acuity Mean Score in the Amblyopic Eye | 18 weeks | Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst |
| Primary | Visual Acuity Distribution in the Amblyopic Eye | 18 weeks | Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst |
| Primary | Mean Change in Visual Acuity in the Amblyopic Eye | baseline to 18 weeks | 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. |
| Primary | Distribution of Change in Visual Acuity in the Amblyopic Eye | baseline to 18 weeks | 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. |
| Secondary | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 18 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 | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 18 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 | Mean Change in Visual Acuity in the Sound Eye | baseline to 18 weeks | 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. |
| Secondary | Distribution of Change in Visual Acuity in the Sound Eye | baseline to 18 weeks | 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. |
| Secondary | Visual Acuity Distribution in the Sound Eye | 18 weeks | Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Acuity Mean Score in the Amblyopic Eye | 18 weeks | 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. | logMAR units | MEAN |
| PRIMARY | Visual Acuity Distribution in the Amblyopic Eye | 18 weeks | Participants | NUMBER | |
| PRIMARY | Mean Change in Visual Acuity in the Amblyopic Eye | baseline to 18 weeks | logMAR units | MEAN | |
| PRIMARY | Distribution of Change in Visual Acuity in the Amblyopic Eye | baseline to 18 weeks | Participants | NUMBER | |
| SECONDARY | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 18 weeks | Not reported among subjects with severe amblyopia | Participants | NUMBER |
| SECONDARY | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 18 weeks | Not reported among subjects with severe amblyopia | Participants | NUMBER |
| SECONDARY | Mean Change in Visual Acuity in the Sound Eye | baseline to 18 weeks | logMAR units | MEAN | |
| SECONDARY | Distribution of Change in Visual Acuity in the Sound Eye | baseline to 18 weeks | Participants | NUMBER | |
| SECONDARY | Visual Acuity Distribution in the Sound Eye | 18 weeks | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group204
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Acuity Mean Score in the Amblyopic Eye | Atropine-Moderate Amblyopia | 0.23 | Standard Deviation 0.16 | logMAR units | |
| Visual Acuity Mean Score in the Amblyopic Eye | Atropine Plus Plano-Moderate Amblyopia | 0.22 | Standard Deviation 0.20 | logMAR units | |
| Visual Acuity Mean Score in the Amblyopic Eye | Atropine-Severe Amblyopia | 0.54 | Standard Deviation 0.26 | logMAR units | |
| Visual Acuity Mean Score in the Amblyopic Eye | Atropine Plus Plano-Severe Amblyopia | 0.50 | Standard Deviation 0.38 | logMAR units | |
| Visual Acuity Distribution in the Amblyopic Eye | Atropine-Moderate Amblyopia | 20/400 (worse) | 0 | Participants | |
| Visual Acuity Distribution in the Amblyopic Eye | Atropine Plus Plano-Moderate Amblyopia | 20/400 (worse) | 0 | Participants | |
| Visual Acuity Distribution in the Amblyopic Eye | Atropine-Severe Amblyopia | 20/400 (worse) | 0 | Participants | |
| Visual Acuity Distribution in the Amblyopic Eye | Atropine Plus Plano-Severe Amblyopia | 20/400 (worse) | 1 | Participants | |
| Visual Acuity Distribution in the Amblyopic Eye | Atropine-Moderate Amblyopia | 20/320 | 0 | Participants | |
| Visual Acuity Distribution in the Amblyopic Eye | Atropine Plus Plano-Moderate Amblyopia | 20/320 | 0 | Participants |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atropine-Moderate Amblyopia | 90 | |
| Overall Study | STARTED | Atropine Plus Plano-Moderate Amblyopia | 90 | |
| Overall Study | STARTED | Atropine-Severe Amblyopia | 26 | |
| Overall Study | STARTED | Atropine Plus Plano-Severe Amblyopia | 34 | |
| Overall Study | 5 Week Visit | Atropine-Moderate Amblyopia | 85 | |
| Overall Study | 5 Week Visit | Atropine Plus Plano-Moderate Amblyopia | 86 | |
| Overall Study | 5 Week Visit | Atropine-Severe Amblyopia | 26 | |
| Overall Study | 5 Week Visit | Atropine Plus Plano-Severe Amblyopia | 30 | |
| Overall Study | 10 Week Visit | Atropine-Moderate Amblyopia | 86 | |
| Overall Study | 10 Week Visit | Atropine Plus Plano-Moderate Amblyopia | 85 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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 | Atropine-Moderate Amblyopia | 8 | 90 | 8 |
| other | Light sensitivity | Eye disorders | Atropine Plus Plano-Moderate Amblyopia | 1 | 90 | 1 |
| other | Light sensitivity | Eye disorders | Atropine-Severe Amblyopia | 1 | 26 | 1 |
| other | Light sensitivity | Eye disorders | Atropine Plus Plano-Severe Amblyopia | 5 | 34 | 5 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atropine-Moderate Amblyopia | ||
| Total, all-cause mortality | Atropine Plus Plano-Moderate Amblyopia | ||
| Total, all-cause mortality | Atropine-Severe Amblyopia | ||
| Total, all-cause mortality | Atropine Plus Plano-Severe Amblyopia | ||
| Total, other adverse events | Atropine-Moderate Amblyopia | 8 | 90 |
| Total, other adverse events | Atropine Plus Plano-Moderate Amblyopia | 1 | 90 |
| Total, other adverse events | Atropine-Severe Amblyopia | 1 | 26 |
| Total, other adverse events | Atropine Plus Plano-Severe Amblyopia | 5 | 34 |
| Total, serious adverse events | Atropine-Moderate Amblyopia | 0 | 90 |
| Total, serious adverse events | Atropine Plus Plano-Moderate Amblyopia | 0 | 90 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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
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/NCT00315302
GET https://conductscience.org/api/trials/v1/NCT00315302/results?page=2