Low Vision Depression Prevention Trial for Age Related Macular Degeneration

Completed · Phase 3

Conditions studied: Age-related Macular Degeneration, Depression

In brief

This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupational therapist collaborates with a low vision optometrist to develop and implement a care plan based on a subject's vision status, rehabilitation potential, and personal rehabilitation goals. An independent rater masked to treatment assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and targeted vision function and vision-related quality of life (secondary outcomes) at baseline and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months to evaluate long-term effects.

Key facts

Study ID

NCT00769015

Run by

Thomas Jefferson University

People needed

188

Starts

2009-06-01

Expected to finish

2014-06-01

Last updated by the study team

2014-11-20

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age at least 65 years old
• Bilateral AMD
• Subthreshold depressive symptoms
• At least 1 vision goal that is important yet difficult to carry out

You may not qualify if…

• Uncontrolled glaucoma, diabetic retinopathy, corneal dystrophy, or cataracts for which surgery within 6 months is likely will be exclusionary conditions
• Current diagnosis of depression
• Cognitive impairment
• Life-threatening illness or any other health conditions that interferes with study activities.
• Patients who have received low vision rehabilitation or home-based OT in the preceding 12 months will be excluded.

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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