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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/OPHTHAL&VIS SCI/FPRC | Other Identifier | UW Madison | |
| Protocol Version 3/20/2025 | Other Identifier | UW Madison |
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The goal of this clinical trial is to compare measurements of geographic atrophy (GA) area between several types of imaging, in order to assess accuracy. The main question to answer is which imaging device provides measurements that are most similar to the standard of care device.
Participants will be patients of a retina doctor at University Station Eye Clinic with geographic atrophy, and can expect to be in the study for 60-75 minutes.
This study is a single site pilot comparative imaging study in which enrolled participants will undergo dilated fundus exam as per standard of care. Study images will be obtained using Optos ultrawide field fundus autofluorescence (FAF) and both blue and green ultrawide field FAF with Zeiss Clarus. Autofluorescence (AF) imaging will also be performed on the Spectralis as it is currently the gold standard. The goal will be to obtain all images in 60-75 minutes over one visit. Images will be assessed, and area of geographic atrophy measured independently by two experienced readers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fundus autofluorescence (FAF) imaging | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectralis FAF imaging | Device | Spectralis is a scanning laser ophthalmoscope which uses a blue light excitation wavelength of 488nm and a 500nm barrier filter to produce FAF images. Spectralis images 20-55 degrees of the retina. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California | Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices. | Up to 75 minutes |
| Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California (Full Range Reported) | Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices. | Up to 75 minutes |
| Number of Eyes With Greater Than 10% Difference in Geographic Atrophy Area Than Heidelberg RegionFinder | up to 75 mintues |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Atrophy Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images | The presence of atrophy outside field 2 will be documented from the two ultrawide field imaging devices | Up to 75 minutes |
| Prevalence of Other Autofluorescence Abnormalities Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images |
| Measure | Description | Time Frame |
|---|---|---|
| Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality | up to 75 minutes | |
| Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality: Junctional Zone Pattern | up to 75 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amitha Domalpally, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fundus Autofluorescence (FAF) Imaging | Spectralis FAF imaging: Spectralis is a scanning laser ophthalmoscope which uses a blue light excitation wavelength of 488nm and a 500nm barrier filter to produce FAF images. Spectralis images 20-55 degrees of the retina. Optos imaging: Optos is an ultrawide field imaging platform which images up to 200 degrees of the retina. It uses both a green-light excitation wavelength of 532nm and a red-light excitation wavelength of 633nm with an emission filter of greater than 540nm to produce FAF images. Zeiss Clarus 700 imaging: Zeiss Clarus 700 is an ultrawide field imaging system with similar retinal coverage to that of Optos. It uses Broad Line Fundus Imaging to produce blue FAF images at excitation wavelengths of 435-500nm and green FAF images at wavelengths of 500-585nm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
participants consented and imaged
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| ID | Title | Description |
|---|---|---|
| BG000 | Fundus Autofluorescence (FAF) Imaging | Spectralis FAF imaging: Spectralis is a scanning laser ophthalmoscope which uses a blue light excitation wavelength of 488nm and a 500nm barrier filter to produce FAF images. Spectralis images 20-55 degrees of the retina. Optos imaging: Optos is an ultrawide field imaging platform which images up to 200 degrees of the retina. It uses both a green-light excitation wavelength of 532nm and a red-light excitation wavelength of 633nm with an emission filter of greater than 540nm to produce FAF images. Zeiss Clarus 700 imaging: Zeiss Clarus 700 is an ultrawide field imaging system with similar retinal coverage to that of Optos. It uses Broad Line Fundus Imaging to produce blue FAF images at excitation wavelengths of 435-500nm and green FAF images at wavelengths of 500-585nm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California | Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices. | Participants (and eyes) with data available for pairwise comparison | Posted | Mean | Standard Deviation | millimeters squared | Up to 75 minutes | eyes | eyes |
|
data collected during 1 imaging visit (up to 75 minutes)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heidelberg Standard Field | Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amitha Domalpally, MD, PhD | University of Wisconsin School of Medicine and Public Health | (608) 262-1334 | domalpally@wisc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2025 | Apr 21, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Optos imaging | Device | Optos is an ultrawide field imaging platform which images up to 200 degrees of the retina. It uses both a green-light excitation wavelength of 532nm and a red-light excitation wavelength of 633nm with an emission filter of greater than 540nm to produce FAF images. |
|
| Zeiss Clarus 700 imaging | Device | Zeiss Clarus 700 is an ultrawide field imaging system with similar retinal coverage to that of Optos. It uses Broad Line Fundus Imaging to produce blue FAF images at excitation wavelengths of 435-500nm and green FAF images at wavelengths of 500-585nm |
|
The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices |
| Up to 75 minutes |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Optos Ultrawide Field FAF Images | 200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm) |
| OG003 | Clarus - Green | 133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm) |
|
|
|
| Primary | Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California (Full Range Reported) | Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices. | Participants (and eyes) with data available for pairwise comparison | Posted | Mean | Full Range | millimeters squared | Up to 75 minutes | eyes | eyes |
|
|
|
| Primary | Number of Eyes With Greater Than 10% Difference in Geographic Atrophy Area Than Heidelberg RegionFinder | Participants (and eyes) with data available for pairwise comparison | Posted | Count of Units | eyes | up to 75 mintues | eyes | eyes |
|
|
|
| Secondary | Prevalence of Atrophy Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images | The presence of atrophy outside field 2 will be documented from the two ultrawide field imaging devices | Posted | Count of Units | eyes | Up to 75 minutes | eyes | eyes |
|
|
|
| Secondary | Prevalence of Other Autofluorescence Abnormalities Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images | The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices | Posted | Count of Units | eyes | Up to 75 minutes | eyes | eyes |
|
|
|
| Other Pre-specified | Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality | Participants (and eyes) with data available for pairwise comparison | Posted | Count of Units | eyes | up to 75 minutes | eyes | eyes |
|
|
|
| Other Pre-specified | Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality: Junctional Zone Pattern | Participants (and eyes) with data available for pairwise comparison | Posted | Count of Units | eyes | up to 75 minutes | eyes | eyes |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Optos Ultrawide Field FAF Images | 200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm) | 0 | 62 | 0 | 62 | 0 | 62 |
| EG002 | Clarus - Green | 133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm) | 0 | 62 | 0 | 62 | 0 | 62 |
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| eyes |
|
| Title | Measurements |
|---|---|
|
| Reticular pseudodrusen |
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| Banded/Diffuse |
|
| None |
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