Submitted for Publication: February 24, 2014; final revision received April 9, 2014; accepted April 10, 2014.
Published Online: May 7, 2014. doi:10.1001/jamaophthalmol.2014.1634.
Study concept and design: Hoffman, Hughbanks-Wheaton, Birch.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Hoffman, Hughbanks-Wheaton, Birch.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Hoffman, Pearson.
Obtained funding: Hoffman, Birch.
Administrative, technical, or material support: Hoffman, Hughbanks-Wheaton, Pearson, Takacs, Klein, Locke.
Study supervision: Hoffman, Hughbanks-Wheaton, Birch.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. DSM Nutritional Products, which provided DHA and placebo capsules gratis, supports a separate infant nutrition clinical trial currently in progress at the Retina Foundation of the Southwest. No other disclosures were reported.
Funding/Support: Dr Hoffman was supported by grant 5RO1FD002543 from the Orphan Products Development program of the US Food and Drug Administration. Dr Birch was supported by grant C-TX02-0704-0274 from the Foundation Fighting Blindness. DSM Nutritional Products provided DHA and placebo capsules gratis.
Role of the Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: The following were members of the data and safety monitoring committee: Gerald Fishman, MD (chair), Lighthouse for the Blind and Visually Impaired, Chicago, Illinois; Norman Salem, PhD (until 2007), National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health until 2007, then DSM Nutritional Products, Columbia, Maryland; Barbara Philippon, RN, MS, independent consultant, Dallas, Texas; Kenneth Alexander, PhD, University of Illinois at Chicago, Chicago; Robert J. Anderson, PhD, University of Illinois at Chicago, Chicago; Martha Neuringer, PhD, Oregon Health & Science University, Beaverton; and John Paul SanGiovanni, ScD, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Committee members received annual compensation from the US Food and Drug Administration (Drs Fishman, Alexander, Anderson, and Neuringer and Ms Philippon) or the Foundation Fighting Blindness (Drs Salem and SanGiovanni). We thank retinal specialists and ophthalmologists across the United States for referrals of patients with this rare orphan disease. Robert Koenekoop, MD, McGill University Health Centre, Montreal, Quebec, Canada, and his staff provided recruitment efforts and assisted with Canadian customs issues; they did not receive compensation for these contributions. Hemaxi Patel, MS, Retina Foundation of the Southwest, Dallas, Texas, assisted with visual function testing and provided attention to patient care; she received compensation as an employee.