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| ID | Type | Description | Link |
|---|---|---|---|
| A536000 | Other Identifier | UW- Madison | |
| SMPH/OPHTHAL&VIS SCI/GEN | Other Identifier | UW- Madison | |
| Protocol Version 11/26/2024 | Other Identifier | UW- Madison |
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The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is:
Participants will undergo FPF imaging using the OcuMet Beacon system.
The goal of this clinical trial is to learn if areas of mitochondrial functional distress in the macula (as imaged using fundus flavoprotein fluorescence) correlate with areas of anatomic disease identified on standard fundus autofluorescence (FAF) imaging.
The study aims to evaluate patterns of anomalous fundus flavoprotein fluorescence (FPF) in patients with advanced geographic atrophy (GA) due to dry age-related macular degeneration.
Participants will undergo FPF imaging using the OcuMet Beacon system and FAF imaging using Heidelberg Spectralis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fundus autofluorescence (FAF) imaging | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OcuMet Beacon | Device | OcuMet Beacon is a novel fundus camera the can detect, capture, and assess FPF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Limits of agreement between the fundus autofluorescence (FAF) area of GA images taken with the Heidelberg Spectralis to the flavoprotein fluorescence (FPF) area of GA with images taken with the OcuMet Beacon | The equivalence test will be performed using the estimated fixed effect coefficient and standard errors derived from the mixed-effects model, where the null hypothesis is that the difference in measurements between the two devices is outside the equivalence bounds of -2.5% to 2.5%. | Up to 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the cross-sectional associations between FPF intensity (average pixel intensity over a 5.5 mm-diameter region centered at the macula) to FAF area at the time of measurement | Up to 45 minutes | |
| Compare the cross-sectional associations between best corrected visual acuity (BCVA - using Early Treatment Diabetic Retinopathy Study, greater number of letters read correctly equals better vision) to FAF area at the time of measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mihai Mititelu, MD, MPH | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology and Visual Sciences | Madison | Wisconsin | 53705 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 | 4 | ||
| Jul 1, 2026 |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Up to 45 minutes |