Improving Function in Age-Related Macular Degeneration
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2005 |
| End Date: | June 2013 |
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.
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.
The primary hypothesis will address treatment group differences in Targeted Vision Function
at 3-months, and secondary hypotheses will the long-term effect (6-months) of Problem
Solving Treatment (PST) on TVF and vision-related quality of life.
at 3-months, and secondary hypotheses will the long-term effect (6-months) of Problem
Solving Treatment (PST) on TVF and vision-related quality of life.
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.
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