Phase 3
N=188
Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Age-related Macular Degeneration · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00769015 ↗Enrolled (actual)
188
Serious AEs
30.9%
Results posted
Nov 2014
Primary outcome: Primary: Depression — 11; 18; 5; 11 participants — p=.067
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BA-LVR (Behavioral); ST-LVR (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression |
11; 18; 5; 11; 6; 7 | .067 |
| SECONDARY Vision Function: Distance Activities |
0.31; 1.12 | .75 |
| SECONDARY Quality of Life: Dependency |
2.07; 5.54 | .68 |
| SECONDARY Vision Function: Near Activities |
4.78; 2.36 | .34 |
| SECONDARY Quality of Life: Mental Health |
2.23; 4.25 | .68 |
| SECONDARY Quality of Life: Role Functioning |
2.33; .93 | .68 |
| SECONDARY Quality of Life: Social Function |
-.38; -2.00 | .68 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age at least 65 years old
- Bilateral AMD
- Subthreshold depressive symptoms
- At least 1 vision goal that is important yet difficult to carry out
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00769015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.