Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2U10EY011751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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The purpose of the study is:
Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.
Little is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense.
In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye.
The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine | Active Comparator | Atropine 1% once each weekend day in the sound eye |
|
| Atropine plus plano | Active Comparator | Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine | Drug | Atropine 1% once each weekend day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity Mean Score in the Amblyopic Eye | 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 | 18 weeks |
| Visual Acuity Distribution in the Amblyopic Eye | 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 | 18 weeks |
| Mean Change in Visual Acuity in the Amblyopic Eye | 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. | baseline to 18 weeks |
| Distribution of Change in Visual Acuity in the Amblyopic Eye | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| David Weakley, M.D. | University of Texas Southwestern Medical Center | Study Chair |
| Susan A. Cotter, O.D. | Southern California College of Optometry at Marshall B. Ketchum University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California College of Optometry | Fullerton | California | 92831 | United States | ||
| UT Southwestern Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19139333 | Result | Pediatric Eye Disease Investigator Group. Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol. 2009 Jan;127(1):22-30. doi: 10.1001/archophthalmol.2008.520. | |
| 19541265 | Result | Repka MX, Kraker RT, Beck RW, Birch E, Cotter SA, Holmes JM, Hertle RW, Hoover DL, Klimek DL, Marsh-Tootle W, Scheiman MM, Suh DW, Weakley DR; Pediatric Eye Disease Investigator Group. Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. J AAPOS. 2009 Jun;13(3):258-63. doi: 10.1016/j.jaapos.2009.03.002. |
Not provided
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Subjects must have had stable visual acuity in glasses (if applicable) before enrollment and randomization.
Between Feb 2005 and May 2007, 240 subjects were randomized at 30 sites (180 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 60 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Atropine-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) |
| FG001 | Atropine Plus Plano-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100) |
| FG002 | Atropine-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) |
| FG003 | Atropine Plus Plano-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atropine-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) |
| BG001 | Atropine Plus Plano-Moderate Amblyopia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age at enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity Mean Score in the Amblyopic Eye | 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 analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle. | Posted | Mean | Standard Deviation | logMAR units | 18 weeks |
|
Adverse events were collected through the 18wk outcome visit.
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atropine-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Light sensitivity | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Kraker | Jaeb Center for Health Research | 813-975-8690 | pedig@jaeb.org |
Not provided
| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Plano Lens |
| Device |
Plano lens for the sound eye |
|
| baseline to 18 weeks |
| 18 weeks |
| Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 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. | 18 weeks |
| Mean Change in Visual Acuity in the Sound Eye | 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. | baseline to 18 weeks |
| Distribution of Change in Visual Acuity in the Sound Eye | 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. | baseline to 18 weeks |
| Visual Acuity Distribution in the Sound Eye | 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 | 18 weeks |
| Dallas |
| Texas |
| 75235 |
| United States |
| 22108357 | Derived | Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007. |
| 20451898 | Derived | Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8. |
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
| BG002 | Atropine-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) |
| BG003 | Atropine Plus Plano-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age at enrollment | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cause of Amblyopia | Number | participants |
|
| Distance Visual Acuity in Amblyopic Eye | 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 | Number | participants |
|
| Distance Visual Acuity in Sound Eye | 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 | Number | participants |
|
| Prior Treatment for Amblyopia at Enrollment | Number | participants |
|
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder. | Number | participants |
|
| Refractive Error in Sound Eye (spherical equivalent/diopters) | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder. | Number | participants |
|
| Distance Visual Acuity in Amblyopic Eye | 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 | Mean | Standard Deviation | log of min angle of resolution (logMAR) |
|
| Distance Visual Acuity in Sound Eye | 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 | Mean | Standard Deviation | log of min angle of resolution (logMAR) |
|
| Intereye Acuity Difference | Intereye difference defined as the difference between logMAR scores (amblyopic eye minus sound eye) | Mean | Standard Deviation | logMAR lines |
|
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder. | Mean | Standard Deviation | diopters |
|
| Refractive Error in Sound Eye (spherical equivalent/diopters) | Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder. | Mean | Standard Deviation | diopters |
|
| OG001 | Atropine Plus Plano-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100) |
| OG002 | Atropine-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) |
| OG003 | Atropine Plus Plano-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400) |
|
|
|
| Primary | Visual Acuity Distribution in the Amblyopic Eye | 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 | Posted | Number | Participants | 18 weeks |
|
|
|
|
| Primary | Mean Change in Visual Acuity in the Amblyopic Eye | 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. | Posted | Mean | Standard Deviation | logMAR units | baseline to 18 weeks |
|
|
|
|
| Primary | Distribution of Change in Visual Acuity in the Amblyopic Eye | 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. | Posted | Number | Participants | baseline to 18 weeks |
|
|
|
|
| Secondary | Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia | 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. | Not reported among subjects with severe amblyopia | Posted | Number | Participants | 18 weeks |
|
|
|
|
| Secondary | Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only | 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. | Not reported among subjects with severe amblyopia | Posted | Number | Participants | 18 weeks |
|
|
|
|
| Secondary | Mean Change in Visual Acuity in the Sound Eye | 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. | Posted | Mean | Standard Deviation | logMAR units | baseline to 18 weeks |
|
|
|
| Secondary | Distribution of Change in Visual Acuity in the Sound Eye | 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. | Posted | Number | Participants | baseline to 18 weeks |
|
|
|
|
| Secondary | Visual Acuity Distribution in the Sound Eye | 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 | Posted | Number | Participants | 18 weeks |
|
|
|
| 0 |
| 90 |
| 8 |
| 90 |
| EG001 | Atropine Plus Plano-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100) | 0 | 90 | 1 | 90 |
| EG002 | Atropine-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400) | 0 | 26 | 1 | 26 |
| EG003 | Atropine Plus Plano-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400) | 0 | 34 | 5 | 34 |
Not provided
Not provided
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| 20/320 |
|
| 20/250 |
|
| 20/200 |
|
| 20/160 |
|
| 20/125 |
|
| 20/100 |
|
| 20/80 |
|
| 20/63 |
|
| 20/50 |
|
| 20/40 |
|
| 20/32 |
|
| 20/25 |
|
| 20/20 |
|
| 20/16 (better) |
|
| Mean Difference (Final Values) |
| 5.1 |
| Standard Deviation |
| 3.7 |
| 2-Sided |
| 95 |
| 3.7 |
| 6.4 |
| No |
| Superiority or Other |
| -2 |
|
| -1 |
|
| 0 |
|
| +1 |
|
| +2 |
|
| +3 |
|
| +4 |
|
| >= +5 (better) |
|
| 800 arcsec |
|
| 400 arcsec |
|
| 200 arcsec |
|
| 100 arcsec |
|
| 60 arcsec |
|
| 40 arcsec (best) |
|
| Not done |
|
| 800 arcsec |
|
| 400 arcsec |
|
| 200 arcsec |
|
| 100 arcsec |
|
| 60 arcsec |
|
| 40 arcsec (best) |
|
| Not done |
|
| -3 |
|
| -2 |
|
| -1 |
|
| 0 |
|
| +1 |
|
| +2 |
|
| +3 (better) |
|
| 20/50 |
|
| 20/40 |
|
| 20/32 |
|
| 20/25 |
|
| 20/20 |
|
| 20/16 (better) |
|