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| 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 this study is:
Although there is consensus that amblyopia can be treated effectively in young children, many eye care practitioners believe that treatment beyond a certain age is ineffective. Some clinicians have believed that a treatment response is unlikely after the age of 6 or 7 years, while others have considered age 9 or 10 years to be the upper age limit for successful treatment. The American Academy of Ophthalmology Preferred Practice Pattern for amblyopia recommends treatment up to age 10 years. The opinion that amblyopia treatment is ineffective in older children may have arisen because the age of 6 to 7 years is thought to be the end of the "critical period" for visual development in humans. This belief, however, was not based on adequate prospectively-collected data.
To address this issue of the response of amblyopia to treatment in children 7 years and older, the Pediatric Eye Disease Investigator Group (PEDIG) conducted a randomized trial of 507 patients (aged 7 to <18 years) with amblyopic eye visual acuity ranging from 20/40 to 20/400. Patients were provided with optimal optical correction and then randomized to a Treatment Group (2 to 6 hours per day of prescribed patching of the sound eye combined with near visual activities for all patients plus atropine one drop per day in the sound eye for 7 to <13 year olds) or an Optical Correction Group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (2 lines) by 24 weeks were considered responders. In the 7 to <13 year olds (N=404), 53% of the Treatment Group were responders compared with 25% of the Optical Correction Group (P<0.001). In the 13 to <18 year olds (N=103), the responder rates were 25% and 23% respectively overall (adjusted P=0.22), but 47% and 20% respectively among patients not previously treated with patching and/or atropine for amblyopia (adjusted P=0.03). Most patients, including responders, were left with a residual visual acuity deficit.
The use of multiple modalities (patching, atropine, near visual activities) in the treatment regimen for the 7 to <13 year olds in this trial (ATS3) was an effort to maximize the therapeutic response. Patients age 13 years and older were prescribed patching but not atropine because of concern that the continual optical blur from the atropine could have a deleterious effect on their ability to drive and perform other activities. Prescribed patching was 2 to 6 hours a day to limit patch wear to non-school hours and because our prior studies of 3 to <7 year olds demonstrated that as little as two hours of patching a day (when combined with near visual activities) is as effective as a greater number of hours. Instructing patients to perform at least one hour of near activities while wearing the patch was based on the unproven clinical opinion that near activities can augment the effect of the occlusion therapy. A PEDIG pilot study suggested that near activities are beneficial and this question of benefit of near activities is currently being studied in another randomized clinical trial. Atropine placed in the sound eye once a day and two days a week has been demonstrated in younger children to be beneficial to the acuity of the amblyopic eye, presumably due to its cycloplegic effect of blurring vision in the sound eye especially at near fixation. In a study comparing daily and weekend atropine, daily atropine was not found to be superior.
The unanswered question from this completed clinical trial is whether prescribing patching or atropine alone could have produced a response similar to the combination therapy, or whether in this age group, one treatment is better than the other. A poll of PEDIG investigators at an investigator meeting on January 15, 2005 indicated that very few are following the treatment regimen used in the prior study (ATS3); rather, most are prescribing monotherapy-either patching or atropine-as the initial treatment for amblyopia in the 7 to <13 year age range. Thus, a trial comparing atropine and patching as amblyopia treatments in 7 to <13 year olds is needed.
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 are: 1) Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day without the aid of reading glasses (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters) and 2) Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and > 4 hours per day for severe amblyopes at 5 weeks if acuity not improved by at least 5 letters).
Optional Ancillary Study As part of the optic nerve imaging ancillary study, retinal nerve fiber layer imaging using optical coherence tomography will be performed on some patients. This will be optional for patients at participating sites. The procedure is not part of standard care. The subject's pupils will need to be dilated, if not already dilated as part of the exam. Testing of both eyes can be completed in about 15 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patching | Active Comparator | Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and >4 hours per day for severe amblyopes at 5 weeks if acuity not improved at least 5 letters) |
|
| Atropine | Active Comparator | Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine | Drug | Atropine 1% each weekend day in the sound eye |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Visual Acuity in the Amblyopic Eye at 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. | 17 weeks |
| Mean Visual Acuity in the Amblyopic Eye at 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. | 17 weeks |
| Distribution of Change in Visual Acuity in the Amblyopic Eye From 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. | Baseline to 17 weeks |
| Mean Change in Visual Acuity in the Amblyopic Eye From 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. | Baseline to 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate 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. |
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Inclusion Criteria:
Inclusion Criteria for Optional Ancillary Study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W. Hertle, M.D. | University of Pittsburgh | Study Chair |
| Mitchell M. Scheiman, O.D. | Pennsylvania College of Optometry | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania College of Optometry | Philadelphia | Pennsylvania | 19141 | United States | ||
| Children's Hospital of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19541265 | Background | 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. | |
| 19327749 | Background | Repka MX, Kraker RT, Tamkins SM, Suh DW, Sala NA, Beck RW; Pediatric Eye Disease Investigator Group. Retinal nerve fiber layer thickness in amblyopic eyes. Am J Ophthalmol. 2009 Jul;148(1):143-7. doi: 10.1016/j.ajo.2009.01.015. Epub 2009 Mar 27. |
| Label | URL |
|---|---|
| PubMed Abstract | View source |
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Subjects must have been wearing optimal spectacle correction for a minimum of 16 weeks or until stability of visual acuity was documented (no improvement in amblyopic eye visual acuity at 2 consecutive visits at least 4 weeks apart) before enrollment and randomization.
Between August 2005 and July 2007, 233 subjects were randomized at 39 certified sites (193 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 40 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).
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| ID | Title | Description |
|---|---|---|
| FG000 | Patching-Moderate Amblyopia | Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100) |
| FG001 | Atropine-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100). |
| FG002 | Patching-Severe Amblyopia | Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400) |
| FG003 | Atropine-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patching-Moderate Amblyopia | Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100) |
| BG001 | Atropine-Moderate Amblyopia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate 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. | Posted | Number | Participants | 17 or 19 weeks |
|
Adverse events were collected through the 17 week outcome visit.
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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 | Patching-Moderate Amblyopia | Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100) |
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| 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 |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Patching |
| Device |
Patching 2 hours per day |
|
|
| Near activities | Procedure | near visual activities for at least one hour per day |
|
| 17 or 19 weeks |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia 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. | 17 or 19 weeks |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 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. | 17 or 19 weeks |
| Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 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. | 17 or 19 weeks |
| Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) | 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. | 17 weeks |
| Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) | 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. | 17 weeks |
| Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only) | Questionnaire scores on the adverse events 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. | 17 weeks |
| Distribution of Visual Acuity in the Fellow Eye at 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. | 17 weeks |
| Mean Visual Acuity in the Fellow Eye at 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. | 17 weeks |
| Distribution of Change in Visual Acuity in the Fellow Eye From 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. | Baseline to 17 weeks |
| Mean Change in Visual Acuity in the Fellow Eye From 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. | Baseline to 17 weeks |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| 19139333 | Background | 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. |
| 21035063 | Background | Felius J, Chandler DL, Holmes JM, Chu RH, Cole SR, Hill M, Huang K, Kulp MT, Lazar EL, Matta NS, Melia M, Wallace DK; Pediatric Eye Disease Investigator Group. Evaluating the burden of amblyopia treatment from the parent and child's perspective. J AAPOS. 2010 Oct;14(5):389-95. doi: 10.1016/j.jaapos.2010.07.009. |
| 19064841 | Result | Scheiman MM, Hertle RW, Kraker RT, Beck RW, Birch EE, Felius J, Holmes JM, Kundart J, Morrison DG, Repka MX, Tamkins SM; Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol. 2008 Dec;126(12):1634-42. doi: 10.1001/archophthalmol.2008.107. |
| 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. |
| PubMed Central HHS Public Access - Full Text | View source |
Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
| BG002 | Patching-Severe Amblyopia | Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400) |
| BG003 | Atropine-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400). |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Age, Customized | Age at enrollment | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Cause of Amblyopia | Number | participants |
|
| Distance Visual Acuity in Amblyopic Eye | 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. | Number | participants |
|
| Distance Visual Acuity in Fellow Eye | 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. | Number | participants |
|
| Prior Treatment for Amblyopia at Enrollment | Number | participants |
|
| Refractive Error in Amblyopic Eye (spherical equivalent) | 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 Fellow Eye (spherical equivalent) | 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 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. | Mean | Standard Deviation | ETDRS letter score |
|
| Distance Visual Acuity in Fellow Eye | 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. | Mean | Standard Deviation | ETDRS letter score |
|
| Intereye Acuity Difference | 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. Intereye difference defined as the difference between ETDRS letter scores (amblyopic eye minus sound eye). | Mean | Standard Deviation | ETDRS letter score |
|
| Refractive Error in Amblyopic Eye (spherical equivalent | 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 | diopter |
|
| Refractive Error in Fellow Eye (spherical equivalent) | 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 | diopter |
|
| OG001 | Atropine-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100). |
| OG002 | Patching-Severe Amblyopia | Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400) |
| OG003 | Atropine-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400). |
|
|
|
| Secondary | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia 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. | Posted | Number | Participants | 17 or 19 weeks |
|
|
|
|
| Secondary | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism | 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. | Posted | Number | Participants | 17 or 19 weeks |
|
|
|
|
| Secondary | Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia | 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. | Posted | Number | Participants | 17 or 19 weeks |
|
|
|
|
| Secondary | Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only) | 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. | Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family. | Posted | Mean | Standard Deviation | Units on a scale | 17 weeks |
|
|
|
|
| Secondary | Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only) | 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. | Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family. | Posted | Mean | Standard Deviation | Units on a scale | 17 weeks |
|
|
|
|
| Secondary | Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only) | Questionnaire scores on the adverse events 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. | Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family. | Posted | Mean | Standard Deviation | Units on a scale | 17 weeks |
|
|
|
|
| Primary | Distribution of Visual Acuity in the Amblyopic Eye at 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 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. | Posted | Number | participants | 17 weeks |
|
|
|
|
| Primary | Mean Visual Acuity in the Amblyopic Eye at 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. | Posted | Mean | Standard Deviation | ETDRS letter score | 17 weeks |
|
|
|
| Primary | Distribution of Change in Visual Acuity in the Amblyopic Eye From 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. | Posted | Number | participants | Baseline to 17 weeks |
|
|
|
|
| Primary | Mean Change in Visual Acuity in the Amblyopic Eye From 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. | Posted | Mean | Standard Deviation | ETDRS letter score | Baseline to 17 weeks |
|
|
|
|
| Secondary | Distribution of Visual Acuity in the Fellow Eye at 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. | Posted | Number | participants | 17 weeks |
|
|
|
| Secondary | Mean Visual Acuity in the Fellow Eye at 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. | Posted | Mean | Standard Deviation | ETDRS letter score | 17 weeks |
|
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| Secondary | Distribution of Change in Visual Acuity in the Fellow Eye From 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. | Posted | Number | participants | Baseline to 17 weeks |
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| Secondary | Mean Change in Visual Acuity in the Fellow Eye From 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. | Posted | Mean | Standard Deviation | ETDRS letter score | Baseline to 17 weeks |
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| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | Atropine-Moderate Amblyopia | Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100). | 0 | 95 | 14 | 95 |
| EG002 | Patching-Severe Amblyopia | Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400) | 0 | 18 | 0 | 18 |
| EG003 | Atropine-Severe Amblyopia | Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400). | 0 | 22 | 5 | 22 |
| Systemic | General disorders | Systematic Assessment | Systemic side effects were reported by 2 subjects using atropine - 1 reported irritability, and another reported urinary urgency, dry mouth, and excessive thirst. |
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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 |
| 800 arcsec |
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| 400 arcsec |
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| 200 arcsec |
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| 100 arcsec |
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| 60 arcsec |
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| 40 arcsec (best) |
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| 800 arcsec |
|
| 400 arcsec |
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| 200 arcsec |
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| 100 arcsec |
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| 60 arcsec |
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| 40 arcsec (best) |
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| >= 2 levels better |
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| Wilcoxon (Mann-Whitney) |
| 0.003 |
| 95 |
| No |
| Superiority or Other |
| 20/320 (23 to 27 letters) |
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| 20/250 (28 to 32 letters) |
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| 20/200 (33 to 37 letters) |
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| 20/160 (38 to 42 letters) |
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| 20/125 (43 to 47 letters) |
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| 20/100 (48 to 52 letters) |
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| 20/80 (53 to 57 letters) |
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| 20/63 (58 to 62 letters) |
|
| 20/50 (63 to 67 letters) |
|
| 20/40 (68 to 72 letters) |
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| 20/32 (73 to 77 letters) |
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| 20/25 (78 to 82 letters) |
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| 20/20 (83 to 87 letters) |
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| 20/16 (88 to 92 letters) (best) |
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| 10 to 14 letters worse |
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| 5 to 9 letters worse |
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| +/- 4 letters |
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| 5 to 9 letters better |
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| 10 to 14 letters better |
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| >=15 letters better |
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| 20/40 (68 to 72 letters) |
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| 20/32 (73 to 77 letters) |
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| 20/25 (78 to 82 letters) |
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| 20/20 (83 to 87 letters) |
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| 20/16 (88 to 92 letters) |
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| 20/12 (93 to 97 letters) (best) |
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| 5 to 9 letters worse |
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| +/- 4 letters |
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| 5 to 9 letters better |
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| >=10 letters better |
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