Vision Response to Dopamine Replacement
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Ocular |
| Therapuetic Areas: | Ophthalmology, Other |
| Healthy: | No |
| Age Range: | 3 - Any |
| Updated: | 5/5/2017 |
| Start Date: | August 2012 |
| End Date: | October 2017 |
| Contact: | Michael C Struck, MD |
| Email: | mcstruck@wisc.edu |
| Phone: | 608-263-9859 |
Interventional Study of Levodopa Replacement on Retinal Function in Oculocutaneous Albinism
The purpose of the study is to evaluate and document physiologic and functional changes in
visual performance and retinal function of patients diagnosed with albinism (a dopamine
deficiency state) following a trial of oral Levodopa/carbidopa treatment.
visual performance and retinal function of patients diagnosed with albinism (a dopamine
deficiency state) following a trial of oral Levodopa/carbidopa treatment.
In this study the investigators propose that the retina itself in albinism is deficient in
dopamine, and vision improvement will occur as a result of improved retinal function in
response to the deficient neurotransmitter dopamine. This study has a pretest-posttest
design in order to determine if improvement in vision is in response to replacement of
deficiency (dopamine). The ERG testing and OCT will be critical determinants to confirm
vision improvement as a result of improved retinal function, but are not primary outcome
data. Main outcome measures will be collected at pre-treatment, 1 month, 3 months, and 4
months. Change in visual acuity as measured in logMAR by Snellen or SVEP after 3 months of
treatment is the primary outcome. Patients include OCA1a patients, OCA1b, OCA2, and
unclassified OCA. OCA1a patients clinically are known to have the worst vision, and
physiologically have the lowest (or absent) levels of tyrosinase function (Dopamine
Production). All patients will be treated with Levodopa/carbidopa 4mg/kg/day in three
divided doses.
dopamine, and vision improvement will occur as a result of improved retinal function in
response to the deficient neurotransmitter dopamine. This study has a pretest-posttest
design in order to determine if improvement in vision is in response to replacement of
deficiency (dopamine). The ERG testing and OCT will be critical determinants to confirm
vision improvement as a result of improved retinal function, but are not primary outcome
data. Main outcome measures will be collected at pre-treatment, 1 month, 3 months, and 4
months. Change in visual acuity as measured in logMAR by Snellen or SVEP after 3 months of
treatment is the primary outcome. Patients include OCA1a patients, OCA1b, OCA2, and
unclassified OCA. OCA1a patients clinically are known to have the worst vision, and
physiologically have the lowest (or absent) levels of tyrosinase function (Dopamine
Production). All patients will be treated with Levodopa/carbidopa 4mg/kg/day in three
divided doses.
Inclusion Criteria:
- clinical diagnosis of oculocutaneous albinism
- age over 3 and weight over 25 lbs.
Exclusion Criteria:
- ocular only albinism
- ocular pathology other than albinism
- neurologic disease, history of myocardial infarction, history of clinical depression,
pregnancy
We found this trial at
1
site
Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Michael C Struck, MD
Phone: 608-265-7557
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
Click here to add this to my saved trials
