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The purpose of this research is to collect preliminary data in preparation for conducting a randomized clinical trial to determine the relative effectiveness of vision rehabilitation in improving overall visual ability (primary aim) and reducing depression (secondary aim) in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration integrated over time.
This is a pilot study to understand the feasibility of conducting a randomized, controlled trial regarding the timing for vision rehabilitation in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration. Prior to initiating the clinical trial, the investigators must be assured that patients with loss in visual ability are willing to be randomized and amenable to deferring vision rehabilitation intervention. Although it is typical for patients receiving usual care to present for vision rehabilitation services years after the onset of anti-VEGF therapy, this manifestation may result from patients being unaware of the existence of vision rehabilitation services to enhance function and reduce depression. As part of the study recruitment, patients will be informed about vision rehabilitation care and, if suffering with difficulty performing everyday activities, they may be unwilling to defer vision rehabilitation. Additionally, the study design may not be feasible to answer the aim should patients in the delayed intervention arms suffer progressive loss in visual ability and seek vision rehabilitation services, resulting in a high drop-out rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vision Rehabilitation Group 1 | Active Comparator | Vision rehabilitation assessment will be scheduled within 1 months of randomization; interventions will be scheduled and vision rehabilitation appointments will be scheduled accordingly. |
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| Vision Rehabilitation Group 2 | Active Comparator | Vision rehabilitation assessment will be scheduled within 7 months of randomization; interventions will be scheduled and vision rehabilitation appointments will be scheduled accordingly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vision rehabilitation | Other | A service menu containing the minimum vision rehabilitation visits will be provided and assessed according to the participant's vision needs. Minimum vision rehabilitation visits include refraction, best-corrected visual acuity assessment, near vision, contrast sensitivity, central visual field test, education and consultation; rehabilitation visit will then be individualized. |
| Measure | Description | Time Frame |
|---|---|---|
| Consent rate | Consent rate of the approached participants | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retention rate | Retention rate of the enrolled participants | 18 months |
| Breaking of randomization in group 2 | Rate of participants crossing over to group 1 from group 2 |
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Inclusion Criteria:
Exclusion Criteria:
Other progressive ocular conditions likely to compromise VA during the study period or upcoming eye surgeries
Anti-VEGF injections in the index eye 8 months prior to enrollment
Unable to give written consent to the study
Impaired hearing or cognitive ability that precludes telephone interviews
Insufficient spoken English or reading ability to complete interviews and understand study materials
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| Name | Affiliation | Role |
|---|---|---|
| Judith Goldstein | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| 18 months |
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |