Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| StreetLab Vision | INDUSTRY |
Not provided
Not provided
Not provided
The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.
The investigators propose two sites for the study, Duke University and UAB. Each site will enroll 100 participants as indicated in the table above, per the AREDS 9-step AMD classification system, with 200 participants in the sample. Because the variance of rod-mediated dark adaptation in AMD patients increases with increasing disease severity, the investigators will implement a larger sample size for intermediate AMD and a smaller sample for patients in normal macular health.
The investigators will collect demographic characteristics (age, race/ethnicity, gender), ocular medical history from the electronic health record, and medication use. In addition, the protocol will focus on measuring the following major components:
Statistical associations will be computed using correlational analysis for the overall sample, within each patient group, and also separately for those with SDD. Sample size estimation is challenging because there is no previous literature on the association between rod-mediated dark adaptation and MNREAD reading performance or MOST performance. With a sample size of 200 participants, the investigators will have adequate statistical power (80%) to detect a correlation of at least 0.20 for the total sample and adequate statistical power to detect within-group correlations of at least 0.40.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early AMD | Other | Study patients who have a diagnosis of early AMD |
|
| Intermediate AMD | Other | Study patients who have a diagnosis of Intermediate AMD |
|
| Geographic Atrophy | Other | Study patients who have a diagnosis of Geographic Atrophy |
|
| AMD Controls | Other | Study patients who have healthy eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streetlab VR | Diagnostic Test | Streetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total number of participants with total ellipsoid zone (EZ) band attenuation | Total EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness = 0 μm. | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of participants with partial ellipsoid zone (EZ) band attenuation | Partial EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness ≤ 20 μm. | Approximately 2 years |
| Rod-mediated dark adaptation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleonora Lad, MD, PhD | Contact | 919-684-4359 | nora.lad@duke.edu | |
| Alice Ventura | Contact | 919-681-6585 | alice.ventura@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eleonora Lad, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Recruiting | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measured for right and left eyes separately using the AdaptDx, a computerized dark adaptometer.
| Single visit, approximately 5-6 hours |
| Reading performance as measured by the MNREAD (Minnesota low vision reading) chart | Reading performance will be assessed binocularly with the MNREAD iPad app on a digital version of the MNREAD chart. The MNREAD is a text based chart used to measure near visual acuity in people with normal or low vision. | Single visit, approximately 5-6 hours |
| Mobility as measured by the Mobility Standardized Test (MOST) | The MOST task involves walking through a maze which can be performed under a range of mesopic and photopic conditions. Scoring is automatically computed based on the duration and mobility errors, which generated a score from 0 to 100, with 100 as the best performance. | Single visit, approximately 5-6 hours |