An interventional study of Spectralis FAF imaging and Optos imaging in Macular Degeneration, Age Related and Geographic Atrophy, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Other
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 62 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
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Exclusion Criteria:
Device: Spectralis FAF imaging · Device: Optos imaging · Device: Zeiss Clarus 700 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 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 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
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.
Time frame: 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.
Time frame: Up to 75 minutes
Number of Eyes With Greater Than 10% Difference in Geographic Atrophy Area Than Heidelberg RegionFinder
Time frame: up to 75 mintues
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
Time frame: Up to 75 minutes
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
Time frame: Up to 75 minutes
Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality
Time frame: up to 75 minutes
Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality: Junctional Zone Pattern
Time frame: up to 75 minutes
| Milestone | Fundus Autofluorescence (FAF) Imaging |
|---|---|
| Started | 62 |
| Completed | 39 |
| Not completed | 23 |
| Withdrew: Excluded for eyes that did not meet the inclusion criteria per clinician or reading center grade | 23 |
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
| millimeters squared | Heidelberg RegionFinder | Heidelberg Manual | Optos Ultrawide Field FAF Images | Clarus - Green |
|---|---|---|---|---|
| Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California | 8.33 ± 5.31 | 8.67 ± 5.48 | 7.86 ± 4.87 | 8.8 ± 5.46 |
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
| millimeters squared | Heidelberg RegionFinder | Heidelberg Manual | Optos Ultrawide Field FAF Images | Clarus - Green |
|---|---|---|---|---|
| Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California (Full Range Reported) | 8.33 (1.33 to 19.2) | 8.67 (1.35 to 21.18) | 7.86 (1.36 to 19.84) | 8.83 (1.48 to 21.37) |
| eyes | Heidelberg Manual | Optos Ultrawide Field FAF Images | Clarus - Green |
|---|---|---|---|
| Number of Eyes With Greater Than 10% Difference in Geographic Atrophy Area Than Heidelberg RegionFinder | 11 | 23 | 24 |
The presence of atrophy outside field 2 will be documented from the two ultrawide field imaging devices
| eyes | Optos Ultrawide Field FAF Images | Clarus |
|---|---|---|
| Prevalence of Atrophy Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images | 4 | 4 |
The presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices
| eyes | Optos Ultrawide Field FAF Images | Clarus |
|---|---|---|
| Prevalence of Other Autofluorescence Abnormalities Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images | 3 | 3 |
| eyes | Heidelberg Standard Field | Optos Ultrawide Field FAF Images | Clarus - Green |
|---|---|---|---|
| Subfoveal | 29 | 28 | 33 |
| Multifocal | 46 | 46 | 47 |
| Reticular pseudodrusen | 35 | 19 | 33 |
| eyes | Heidelberg Standard Field | Optos Ultrawide Field FAF Images | Clarus - Green |
|---|---|---|---|
| Focal | 5 | 6 | 6 |
| Patchy | 5 | 1 | 1 |
| Banded/Diffuse | 50 | 51 | 52 |
| None | 1 | 3 | 2 |
Collected over data collected during 1 imaging visit (up to 75 minutes). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Heidelberg Standard Field | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Optos Ultrawide Field FAF Images | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Clarus - Green | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
participants consented and imaged
| Age, Customized(Participants) | Fundus Autofluorescence (FAF) Imaging |
|---|---|
| less than 50 years | 0 |
| 50 years or greater | 62 |
| Sex: Female, Male(Participants) | Fundus Autofluorescence (FAF) Imaging |
|---|---|
| Female | 43 |
| Male | 19 |
| Race and Ethnicity Not Collected(Participants) | Fundus Autofluorescence (FAF) Imaging |
|---|
| Region of Enrollment(participants) | Fundus Autofluorescence (FAF) Imaging |
|---|---|
| United States | 62 |
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University of Wisconsin, Madison