Improving Function in Age-Related Macular Degeneration

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PST

Problem Solving Treatment (PST)

Group Type EXPERIMENTAL

PST

Intervention Type BEHAVIORAL

PST will be delivered in subjects' homes over the course of 6 weeks.

ST

Supportive Therapy (ST)

Group Type PLACEBO_COMPARATOR

ST

Intervention Type BEHAVIORAL

ST will be delivered in subjects' homes over the course of 6 weeks.

Interventions

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PST

PST will be delivered in subjects' homes over the course of 6 weeks.

Intervention Type BEHAVIORAL

ST

ST will be delivered in subjects' homes over the course of 6 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No