Amblyopia
Conditions
Keywords
Amblyopia, Patching, Levodopa
Brief summary
This pilot study is being conducted as a prelude to a randomized trial to compare levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to demonstrate recruitment potential, to provide prospective data on the tolerability of levodopa as a treatment for amblyopia, to provide limited data on its safety, to provide limited data on it's efficiency, and to provide data to assist in selecting a dose to use in a subsequent phase 3 randomized trial. In addition, this study will provide the opportunity for investigators to gain experience in using levodopa prior to a randomized trial.
Detailed description
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal visual acuity in the amblyopic eye. In a previous PEDIG study (ATS3) where children 7 to 13 years old were treated with atropine and patching, only 36% of the children with moderate amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.
Interventions
Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation)
DEVICEpatching
2 hours daily patching
Sponsors
National Eye Institute (NEI)
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 8 to \< 18 years old * Amblyopia associated with strabismus, anisometropia, or both * Visual acuity in the amblyopic eye 18 to 67 letters inclusive (20/50 to 20/400) * Visual acuity in the sound eye ≥ 78 letters (20/25 or better) * Current amblyopia treatment of at least 2 hours patching per day * No improvement in best-corrected amblyopic eye visual acuity between two consecutive visits at least 4 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement of more than 4 letters or one logMAR line.
Exclusion criteria
* Myopia more than -6.00 D (spherical equivalent) in either eye. * Current vision therapy or orthoptics * Ocular cause for reduced visual acuity • nystagmus per se does not exclude the subject if the above visual acuity criteria are met * Prior intraocular or refractive surgery * History of narrow-angle glaucoma * Strabismus surgery planned within 16 weeks * Known allergy to levodopa-carbidopa * History of dystonic reactions * Current requirement to take oral iron supplements including multivitamins containing iron during the 8 weeks of treatment with levodopa-carbidopa * Current use of antihypertensive, anti-depressant medications, phenothiazines, butyrophenones, risperidone and isoniazid, non-specific monoamine oxidase inhibitors * Current use of medication for the treatment of attention deficit hyperactivity disorder * Known gastrointestinal or liver disease * History of melanoma * Known psychological problems * Known skin reactions to patch or bandage adhesives * Prior levodopa treatment * Current treatment with topical atropine * Females who are pregnant, lactating, or intending to become pregnant within the next 16 weeks. * A negative urine pregnancy test will be required for all females who have experienced menarche. * Requirements regarding the establishment of pregnancy and monitoring of pregnancy over the course of the study as defined by each individual Institutional Review Board may supersede these criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 9 weeks after starting levodopa | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.). |
| Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 9 weeks after starting levodopa | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. |
| Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | baseline to 9 weeks | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity. |
| Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | baseline to 9 weeks | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity. |
| Tolerability of Study Medication-Adverse Event Reporting | 24 weeks | Number of adverse events reported throughout entire study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment | enrollment to 4 weeks | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity. |
| Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 4 weeks after enrollment | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.). |
| Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | baseline to 10 weeks after stopping levodopa | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity. |
| Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | baseline to 10 weeks after stopping levodopa | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity. |
| Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment | 4 weeks after enrollment | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. |
| Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 10 weeks after stopping levodopa | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.). |
| Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 10 weeks after stopping levodopa | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. |
| Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | enrollment to 4 weeks | Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity. |
Countries
United States
Participant flow
Recruitment details
Eligibility criteria included age 8 to \<18 years, best-corrected visual acuity in the amblyopic eye between 67 and 18 letters inclusive measured with E-ETDRS, fellow eye best-corrected visual acuity of 78 letters or better, and the presence or history of strabismus and/or anisometropia.
Pre-assignment details
At enrollment, subjects were required to have been treated with at least 2 hours of patching per day of daily patching and while on that therapy, have had stable visual acuity (5 letters or one logMAR line of improvement since a previous visit at least 8 weeks earlier)
Participants by arm
| Arm | Count |
|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam. | 16 |
| Higher Dose 0.76 mg Levodopa/Carbidopa Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam. | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | Higher Dose 0.76 mg Levodopa/Carbidopa | Lower Dose 0.51 mg Levodopa/Carbidopa | Total |
|---|---|---|---|
| Age, Continuous | 11.0 years STANDARD_DEVIATION 2.2 | 11.3 years STANDARD_DEVIATION 2.2 | 11.1 years STANDARD_DEVIATION 2.2 |
| Age, Customized 10 to <11 | 4 participants | 3 participants | 7 participants |
| Age, Customized 11 to <12 | 1 participants | 3 participants | 4 participants |
| Age, Customized 12 to <13 | 3 participants | 0 participants | 3 participants |
| Age, Customized 13 to <14 | 1 participants | 3 participants | 4 participants |
| Age, Customized 14 to <15 | 0 participants | 2 participants | 2 participants |
| Age, Customized 15 to <16 | 2 participants | 0 participants | 2 participants |
| Age, Customized 16 to <17 | 0 participants | 0 participants | 0 participants |
| Age, Customized 17 to <18 | 0 participants | 0 participants | 0 participants |
| Age, Customized 8 to <9 | 3 participants | 3 participants | 6 participants |
| Age, Customized 9 to <10 | 3 participants | 2 participants | 5 participants |
| Cause of Amblyopia Anisometropia | 5 participants | 6 participants | 11 participants |
| Cause of Amblyopia Strabismus | 5 participants | 2 participants | 7 participants |
| Cause of Amblyopia Strabismus and anisometropia | 7 participants | 8 participants | 15 participants |
| Distance Visual Acuity in Amblyopic Eye 20/100 (48 to 52 letters) | 0 participants | 2 participants | 2 participants |
| Distance Visual Acuity in Amblyopic Eye 20/125 (43 to 47 letters) | 1 participants | 0 participants | 1 participants |
| Distance Visual Acuity in Amblyopic Eye 20/160 (38 to 42 letters) | 1 participants | 1 participants | 2 participants |
| Distance Visual Acuity in Amblyopic Eye 20/200 (33 to 37 letters) | 1 participants | 1 participants | 2 participants |
| Distance Visual Acuity in Amblyopic Eye 20/250 (28 to 32 letters) | 1 participants | 0 participants | 1 participants |
| Distance Visual Acuity in Amblyopic Eye 20/320 (23 to 27 letters) | 0 participants | 0 participants | 0 participants |
| Distance Visual Acuity in Amblyopic Eye 20/400 (18 to 22 letters) | 1 participants | 0 participants | 1 participants |
| Distance Visual Acuity in Amblyopic Eye 20/50 (63 to 67 letters) | 1 participants | 4 participants | 5 participants |
| Distance Visual Acuity in Amblyopic Eye 20/63 (58 to 62 letters) | 5 participants | 4 participants | 9 participants |
| Distance Visual Acuity in Amblyopic Eye 20/80 (53 to 57 letters) | 6 participants | 4 participants | 10 participants |
| Distance Visual Acuity in Fellow Eye 20/12 (93 to 97 letters) | 0 participants | 1 participants | 1 participants |
| Distance Visual Acuity in Fellow Eye 20/16 (88 to 92 letters) | 5 participants | 5 participants | 10 participants |
| Distance Visual Acuity in Fellow Eye 20/20 (83 to 87 letters) | 8 participants | 6 participants | 14 participants |
| Distance Visual Acuity in Fellow Eye 20/25 (78 to 82 letters) | 4 participants | 4 participants | 8 participants |
| Mean (SD) Distance Visual Acuity in Amblyopic Eye | 50.5 letters STANDARD_DEVIATION 12.2 | 56.2 letters STANDARD_DEVIATION 8.8 | 53.2 letters STANDARD_DEVIATION 10.9 |
| Mean (SD) Distance Visual Acuity in Fellow Eye | 85.5 letters STANDARD_DEVIATION 3.3 | 86.4 letters STANDARD_DEVIATION 4.5 | 85.9 letters STANDARD_DEVIATION 3.9 |
| Mean (SD) Intereye Acuity Difference | 35.1 letters STANDARD_DEVIATION 13.6 | 30.2 letters STANDARD_DEVIATION 11.7 | 32.7 letters STANDARD_DEVIATION 12.7 |
| Mean (SD) Spherical Equivalent Refractive Error in Amblyopic Eye | 3.28 diopters STANDARD_DEVIATION 1.93 | 4.05 diopters STANDARD_DEVIATION 1.92 | 3.65 diopters STANDARD_DEVIATION 1.93 |
| Mean (SD) Spherical Equivalent Refractive Error in Fellow Eye | 1.04 diopters STANDARD_DEVIATION 0.99 | 1.20 diopters STANDARD_DEVIATION 1.17 | 1.12 diopters STANDARD_DEVIATION 1.07 |
| Race/Ethnicity African-American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity Hispanic or Latino | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity More than one race | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity Unknown/Not reported | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity White | 17 participants | 14 participants | 31 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) <0.00D | 1 participants | 0 participants | 1 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) 0 to < +1.00D | 2 participants | 1 participants | 3 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) +1.00 to <+2.00D | 1 participants | 1 participants | 2 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) +2.00 to <+3.00D | 2 participants | 2 participants | 4 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) +3.00 to <+4.00D | 2 participants | 3 participants | 5 participants |
| Refractive Error in Amblyopic Eye (spherical equivalent/diopters) greater than or equal to +4.00D | 9 participants | 9 participants | 18 participants |
| Refractive Error in Fellow Eye (spherical equivalent/diopters) <0.00D | 0 participants | 1 participants | 1 participants |
| Refractive Error in Fellow Eye (spherical equivalent/diopters) 0 to < +1.00D | 10 participants | 6 participants | 16 participants |
| Refractive Error in Fellow Eye (spherical equivalent/diopters) +1.00 to <+2.00D | 3 participants | 5 participants | 8 participants |
| Refractive Error in Fellow Eye (spherical equivalent/diopters) +2.00 to <+3.00D | 3 participants | 2 participants | 5 participants |
| Refractive Error in Fellow Eye (spherical equivalent/diopters) +3.00 to <+4.00D | 1 participants | 2 participants | 3 participants |
| Refractive Error in Fellow Eye (spherical equivalent/diopters) greater than or equal to +4.00D | 0 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
| Weight in Kilograms | 34 kilograms | 47 kilograms | 42 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 16 | 11 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).
Time frame: 9 weeks after starting levodopa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/80 (53 to 57) | 1 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/50 (63 to 67) | 4 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/100 (47 to 52 letters) | 2 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/40 (68-72 letters) | 3 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/63 (58 to 62) | 3 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/32 (73 to 77 letters) | 1 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | <20/100 (<47 letters) | 2 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/32 (73 to 77 letters) | 1 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | <20/100 (<47 letters) | 5 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/100 (47 to 52 letters) | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/80 (53 to 57) | 1 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/63 (58 to 62) | 5 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/50 (63 to 67) | 3 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 20/40 (68-72 letters) | 2 participants |
Primary
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Time frame: baseline to 9 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | 5 to 9 letters worse | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | 5 to 9 letters better | 5 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | 10 to 14 letters worse | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | 10 to 14 letters better | 2 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | Within plus or minus 4 letters | 9 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | >=15 letters better | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | >=15 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | >=15 letters better | 1 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | >=15 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | 10 to 14 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | 5 to 9 letters worse | 1 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | Within plus or minus 4 letters | 5 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | 5 to 9 letters better | 6 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa | 10 to 14 letters better | 4 participants |
Primary
Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Time frame: 9 weeks after starting levodopa
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 59.9 letters | Standard Deviation 9.7 |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 56.5 letters | Standard Deviation 12.7 |
Primary
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Time frame: baseline to 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 3.8 letters | Standard Deviation 3.5 |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa | 6.1 letters | Standard Deviation 5.6 |
Comparison: Given this was pilot study, no formal sample size estimates were calculated.95% CI: [-6, 1]
Primary
Tolerability of Study Medication-Adverse Event Reporting
Number of adverse events reported throughout entire study.
Time frame: 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Rash | 1 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Ear ache | 1 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Fatigue/Sleepiness | 3 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Fever | 1 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Cold/Upper Respiratory Infection/Cough | 3 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Loss of appetite | 2 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Dizziness/light-headedness | 3 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Nightmare | 1 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Flu | 2 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Knee injury | 1 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Conjunctivitis | 0 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Sinus infection | 1 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Headache | 6 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Weight loss | 1 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Muscle pain | 0 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Constipation | 1 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Nausea/Vomiting | 2 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Finger injury | 0 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Stomach ache | 0 events |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Pulled muscle | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Stomach ache | 2 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Headache | 6 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Cold/Upper Respiratory Infection/Cough | 6 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Rash | 3 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Flu | 1 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Nausea/Vomiting | 1 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Fatigue/Sleepiness | 1 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Dizziness/light-headedness | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Conjunctivitis | 2 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Muscle pain | 2 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Pulled muscle | 1 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Ear ache | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Fever | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Loss of appetite | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Nightmare | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Knee injury | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Sinus infection | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Weight loss | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Constipation | 0 events |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Tolerability of Study Medication-Adverse Event Reporting | Finger injury | 1 events |
Secondary
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).
Time frame: 10 weeks after stopping levodopa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/80 (53 to 57) | 3 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/50 (63 to 67) | 2 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/100 (47 to 52 letters) | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/40 (68-72 letters) | 1 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/63 (58 to 62) | 4 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/32 (73 to 77 letters) | 3 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | <20/100 (<47 letters) | 2 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/32 (73 to 77 letters) | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | <20/100 (<47 letters) | 5 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/100 (47 to 52 letters) | 1 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/80 (53 to 57) | 2 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/63 (58 to 62) | 3 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/50 (63 to 67) | 6 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 20/40 (68-72 letters) | 0 participants |
Secondary
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).
Time frame: 4 weeks after enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/80 (53 to 57) | 1 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/50 (63 to 67) | 4 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/100 (47 to 52 letters) | 2 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/40 (68-72 letters) | 3 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/63 (58 to 62) | 4 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/32 (73 to 77 letters) | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | <20/100 (<47 letters) | 2 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/32 (73 to 77 letters) | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | <20/100 (<47 letters) | 4 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/100 (47 to 52 letters) | 1 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/80 (53 to 57) | 3 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/63 (58 to 62) | 5 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/50 (63 to 67) | 3 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment | 20/40 (68-72 letters) | 1 participants |
Secondary
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Time frame: baseline to 10 weeks after stopping levodopa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | 5 to 9 letters worse | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | 5 to 9 letters better | 6 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | 10 to 14 letters worse | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | 10 to 14 letters better | 2 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | Within plus or minus 4 letters | 7 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | >=15 letters better | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | >=15 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | >=15 letters better | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | >=15 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | 10 to 14 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | 5 to 9 letters worse | 1 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | Within plus or minus 4 letters | 8 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | 5 to 9 letters better | 7 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa | 10 to 14 letters better | 1 participants |
Secondary
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Time frame: enrollment to 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | 5 to 9 letters worse | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | 5 to 9 letters better | 5 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | 10 to 14 letters worse | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | 10 to 14 letters better | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | Within plus or minus 4 letters | 11 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | >=15 letters better | 0 participants |
| Lower Dose 0.51 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | >=15 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | >=15 letters better | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | >=15 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | 10 to 14 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | 5 to 9 letters worse | 0 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | Within plus or minus 4 letters | 9 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | 5 to 9 letters better | 7 participants |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment | 10 to 14 letters better | 1 participants |
Secondary
Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.
Time frame: 10 weeks after stopping levodopa
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 60.6 letters | Standard Deviation 11.1 |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 53.9 letters | Standard Deviation 11.4 |
Secondary
Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.
Time frame: 4 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment | 59.1 letters | Standard Deviation 9.2 |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment | 54.3 letters | Standard Deviation 12.9 |
Secondary
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Time frame: baseline to 10 weeks after stopping levodopa
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 4.9 letters | Standard Deviation 3.7 |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa | 3.5 letters | Standard Deviation 4.7 |
Secondary
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment
Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.
Time frame: enrollment to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Dose 0.51 mg Levodopa/Carbidopa | Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment | 2.9 letters | Standard Deviation 2.8 |
| Higher Dose 0.76 mg Levodopa/Carbidopa | Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment | 3.8 letters | Standard Deviation 3.6 |