Original articleLow Vision Depression Prevention Trial in Age-Related Macular Degeneration: A Randomized Clinical Trial
Section snippets
Eligibility and Trial Design
Institutional review board/ethics committee approval was obtained to conduct VITAL (clinicaltrials.gov NCT00769015). All subjects provided informed consent; study procedures were compliant with the Health Insurance Portability and Accountability Act and adhered to the tenets of the Declaration of Helsinki. Subjects were recruited from a large private retina practice associated with the Wills Eye Hospital, Philadelphia, Pennsylvania, who met the following inclusion criteria: (1) age >65 years,
Results
Figure 1 depicts the study flow chart. From July 2009 to February 2013, we reviewed the records of 2324 potentially eligible patients. Of them, 1158 (49.8%) declined participation, 706 (30.4%) were ineligible, and 272 (11.8%) could not be reached. There were no differences between enrolled subjects and eligible patients who declined participation with regard to age, sex, or visual acuity (data not shown). Baseline assessments were conducted on 222 subjects. Of them, 23 subjects declined further
Discussion
We found that an integrated mental health and low vision intervention halved the incidence of depressive disorders (i.e., 12.6% vs 23.4%) relative to standard outpatient LVR in a high-risk population of patients with AMD. Previous studies indicate that the incidence of depression in the absence of any rehabilitative treatment in patients with AMD ranges from 20% to 28%.28, 29 The preventive efficacy of BA+LVR was strong, with an NNT of 9 to prevent 1 case of depression. For subjects with worse
Acknowledgments
A Data and Safety Monitoring Committee ensured subject safety and supervised recruitment, data collection and analyses, and preparation of this manuscript. The committee members were Sheryl F. Kelsey, PhD, Chair (University of Pittsburgh, Pittsburgh, PA); Dianne M. Bartels, RN, MA, PhD (University of Minnesota, Minneapolis, MN); Donald C. Fletcher, MD (California Pacific Medical Center/Smith-Kettlewell Eye Research Institute, San Francisco, CA); Michele Melia, ScM (Jaeb Center for Health
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Financial Disclosure(s): This work was supported by NEI grant U01 EY018819.
The authors have no proprietary or commercial interest in any materials discussed in this article.
Members of the Data and Safety Monitoring Committee and the Wills Eye Study Group are: The Wills Eye AMD Study Group: William E. Benson, MD, Gary C. Brown, MD, Jay L. Federman, MD, Mitchell S. Fineman, MD, David H. Fischer, MD, Sunir J. Garg, MD, Allen C. Ho, MD, Jason Hsu, MD, Richard S. Kaiser, MD, Alfred C. Lucier, MD, Joseph I. Maguire, MD, J. Arch McNamara, MD,† Carl H. Park, MD, Carl D. Regillo, MD, Lov K. Sarin, MD, Arunan Sivalingam, MD, Marc J. Spirn, MD, and James F. Vander, MD.
†Deceased.