Applicant Department of Ophthalmology Meeting Date Description of Request Department of Ophthalmology Research Fund Amount Requested $ 150,000 Contact Person
Purpose: To provide research funds for Department of Ophthalmology Faculty. Please see attached.
How will item be identified as being purchased by Lions? Minnesota Lions acknowledged in research papers Who will be responsible for maintenance? Not Applicable How often will this item be used? Not Applicable Who will own the item after purchase? Not Applicable When will the item be purchased? Not Applicable Signature of Requestor GRANT APPLICATION
Fiscal Year Number B-19a
Applicant Department of Ophthalmology Meeting Date Description of Request Department of Ophthalmology Research Fund:
Support for Clinical Trial to Improve Vision in Albinism
Amount Requested $ 50,000* * Please note that the entire project will cost $300,000. We have solicited funds from other organizations
to complete the study. This request from the Lions is necessary to initiate the study.
Contact Person Purpose: This randomized, double-masked, placebo-controlled clinical trial is designed to determine if the drug, levodopa/carbidopa, will improve vision in individuals with albinism. Due to the large number of children seen at the International Albinism Center (IAC) at the University of Minnesota, we are in a unique position to study the effect of this drug in those with albinism. Reduced vision is their most important disability, and improving visual acuity even modestly can have a profound effect on quality of life (QOL). Studies of albino mice have shown that this drug has significantly enhanced the number of retinal ganglion cells and the outer nuclear layer. Studies of this drug for amblyopia (lazy eye) in children show that it is tolerated well by children, and that it can enhance the effect of patching. This will be the first drug trial in albinism, with plans to recruit 45 patients (over 400 patients are in the database at the IAC). After consent, individuals will be randomized to placebo or a high or medium dose of the drug, and then followed for 20 weeks. Primary outcome is visual acuity, with secondary outcomes being QOL, assessed with a standard questionnaire, and evaluation of photosensitivity. This study will be approved by the IRB and the FDA. Project Details Who is responsible for project leadership?
Who will be responsible for completion of the project? C. Gail Summers, MD, Director of IAC and Pediatric Ophthalmology and Strabismus Service What is the timetable for completion of the project? Begin enrollment in December, 2009, complete recruitment by the end of 2010, continue follow-up in 2011; data analysis, presentation, publication in 2012. When, and to whom, will disbursements be made? Laura Shifrin, Department of Ophthalmology How will study be identified as being funded by Lions? The study results will be presented at meetings and will be published, with recognition being given to the Minnesota Lions grant support. Signature of Requestor
Albinism is an inherited disorder affecting production of melanin, a natural substance that gives color (pigment) to hair, skin, and the iris of the eye. This can be manifested as reduced pigment in the eye, and also in the hair and skin. People with albinism always have problems with vision (not correctable with eyeglasses) and many have low vision. Many forms of albinism are associated with the following symptoms:
• Crossed eyes (strabismus) • Light sensitivity (photophobia) • Rapid eye movements (nystagmus) • Vision problems, even functional blindness
Information from the International Albinism Center and MedlinePlus (a service of the US. National Library of Medicine and the National Institutes of Health).
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