We propose a randomized, controlled clinical trial, the Improving Function in AMD Trial {IFAMD), to test the efficacy of Problem-Solving Treatment (PST) to improve vision function in older persons with age-related macular degeneration (AMD). AMD is a highly prevalent, disabling disease of aging that causes severe vision loss and functional decline. It is the leading cause of blindness in older persons in the United States and may affect more than 10 million people. Currently, there are no effective treatments to restore vision. Thus, improving Vision Function is a major goal of treatment. Vision function refers to vision-related abilities to perform daily living activities (e.g. reading recipes to prepare meals). Decrements in vision function will become a major public health problem as the population ages and the prevalence of AMD increases. ? ? PST is a brief, standardized, cognitive-behavioral treatment that teaches problem-solving skills. We believe PST will enable patients with AMD find practical solutions to vision-related problems and thereby improve vision function. We will recruit 240 AMD patients from the retina clinics of Wills Eye Hospital, Philadelphia, PA, with bilateral AMD and visual acuity worse than 20/70 in the better eye and no worse than 20/400 in the fellow eye. PST-trained nurses will deliver 6 1-hour, in-home sessions to the 120 subjects randomized to PST. The control treatment is Supportive Therapy (ST), a similarly structured, standardized psychological treatment that controls for the non-specific effects of treatment (n = 120). ST contains no active elements beyond its non-specific components; in this way it is a placebo treatment. Independent raters, masked to treatment assignment, will assess Targeted Vision Function (primary outcome) and vision-related quality of life (secondary outcome) at 3 months to assess PST's efficacy, and at 6 months to evaluate its long-term effects. As the population ages, the disability of AMD will become more prevalent, costly, and burdensome to patients, families, and ophthalmologists. This makes devising and testing practical and affordable interventions to improve vision function a national priority. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01EY015839-03
Application #
7291526
Study Section
Special Emphasis Panel (ZEY1-VSN (04))
Program Officer
Kurinij, Natalie
Project Start
2005-09-30
Project End
2010-07-31
Budget Start
2007-08-01
Budget End
2008-07-31
Support Year
3
Fiscal Year
2007
Total Cost
$864,079
Indirect Cost
Name
Thomas Jefferson University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
053284659
City
Philadelphia
State
PA
Country
United States
Zip Code
19107
Rovner, Barry W; Casten, Robin J; Hegel, Mark T et al. (2013) Improving function in age-related macular degeneration: a randomized clinical trial. Ophthalmology 120:1649-55
Rovner, Barry W; Casten, Robin J; Hegel, Mark T et al. (2011) Improving function in age-related macular degeneration: design and methods of a randomized clinical trial. Contemp Clin Trials 32:196-203
Rovner, Barry W; Casten, Robin J; Massof, Robert W et al. (2011) Psychological and cognitive determinants of vision function in age-related macular degeneration. Arch Ophthalmol 129:885-90
Rovner, Barry W; Casten, Robin J; Leiby, Benjamin E (2009) Variability in depressive symptoms predicts cognitive decline in age-related macular degeneration. Am J Geriatr Psychiatry 17:574-81
Rovner, Barry W; Casten, Robin J (2008) Preventing late-life depression in age-related macular degeneration. Am J Geriatr Psychiatry 16:454-9
Rovner, Barry W; Casten, Robin J; Hegel, Mark T et al. (2007) Preventing depression in age-related macular degeneration. Arch Gen Psychiatry 64:886-92
Rovner, Barry W; Casten, Robin J; Hegel, Mark T et al. (2007) Dissatisfaction with performance of valued activities predicts depression in age-related macular degeneration. Int J Geriatr Psychiatry 22:789-93
Rovner, Barry W; Casten, Robin J; Hegel, Mark T et al. (2006) Minimal depression and vision function in age-related macular degeneration. Ophthalmology 113:1743-7