Improving Function in Age-Related Macular Degeneration
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: PST; ST
Intervention description: PST will be delivered in subjects' homes over the course of 6 weeks.; ST will be delivered in subjects' homes over the course of 6 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 241.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Age-Related Macular Degeneration; AMD; Vision Function; Problem Solving Treatment; PST

Summary:

      This randomized, controlled clinical trial will 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 Institute,
      Philadelphia, PA, with bilateral AMD and visual acuity worse than 20/70 in the better eye.
      PST-trained therapists 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Being at least 65 years old

          -  Having bilateral Age-Related Macular Degeneration (AMD) (atrophic or neovascular)

          -  Having a best corrected visual acuity of 20/70 or worse

          -  Moderate difficulty in at least one valued vision functional goal

        Exclusion Criteria:

          -  Ophthalmologic Criteria. Patients who have uncontrolled glaucoma (continued visual
             field loss and increase in optic nerve cupping), diabetic retinopathy (due to macular
             edema), or cataracts for which surgery within 6 months is likely will not be eligible
             to participate. This information will be obtained from patients' ophthalmology charts
             and discussion with the patient's ophthalmologist.

          -  Cognitive Impairment Criteria. Cognitive functioning will be evaluated by the Project
             Director during the telephone screen (see Chapter 9). Patients with cognitive
             impairment will not be eligible to participate.

          -  Health Criteria. Patients with life-threatening illness (e.g., terminal cancer, need
             for oxygen) will not be eligible to participate. Information regarding heath status
             will be gleaned from patient's ophthalmology charts.