Trial Outcomes & Findings for COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (NCT NCT05961332)
NCT ID: NCT05961332
Last Updated: 2026-07-10
Results Overview
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Up to 75 minutes
Results posted on
2026-07-10
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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62 124
|
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Overall Study
COMPLETED
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39 61
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Overall Study
NOT COMPLETED
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23 63
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Reasons for withdrawal
| Measure |
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
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|---|---|
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Overall Study
excluded for eyes that did not meet the inclusion criteria per clinician or reading center grade
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23
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fundus Autofluorescence (FAF) Imaging
n=62 Participants
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
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|---|---|
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Age, Customized
less than 50 years
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0 Participants
n=62 Participants
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Age, Customized
50 years or greater
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62 Participants
n=62 Participants
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Sex: Female, Male
Female
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43 Participants
n=62 Participants
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Sex: Female, Male
Male
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19 Participants
n=62 Participants
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Region of Enrollment
United States
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62 participants
n=62 Participants
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PRIMARY outcome
Timeframe: Up to 75 minutesPopulation: Participants (and eyes) with data available for pairwise comparison
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
Outcome measures
| Measure |
Heidelberg RegionFinder
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
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Heidelberg Manual
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
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Optos Ultrawide Field FAF Images
n=61 eyes
200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm)
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Clarus - Green
n=61 eyes
133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm)
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|---|---|---|---|---|
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Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California
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8.33 millimeters squared
Standard Deviation 5.31
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8.67 millimeters squared
Standard Deviation 5.48
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7.86 millimeters squared
Standard Deviation 4.87
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8.8 millimeters squared
Standard Deviation 5.46
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PRIMARY outcome
Timeframe: Up to 75 minutesPopulation: Participants (and eyes) with data available for pairwise comparison
Graders will independently measure area of GA from images of each device. The measurements (in mm²) will be compared between the devices.
Outcome measures
| Measure |
Heidelberg RegionFinder
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Heidelberg Manual
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Optos Ultrawide Field FAF Images
n=61 eyes
200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm)
|
Clarus - Green
n=61 eyes
133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm)
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|---|---|---|---|---|
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Comparison of Geographic Atrophy Area Measurements With Heidelberg Spectralis to Zeiss Clarus 700 and Optos California (Full Range Reported)
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8.33 millimeters squared
Interval 1.33 to 19.2
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8.67 millimeters squared
Interval 1.35 to 21.18
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7.86 millimeters squared
Interval 1.36 to 19.84
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8.83 millimeters squared
Interval 1.48 to 21.37
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PRIMARY outcome
Timeframe: up to 75 mintuesPopulation: Participants (and eyes) with data available for pairwise comparison
Outcome measures
| Measure |
Heidelberg RegionFinder
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Heidelberg Manual
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Optos Ultrawide Field FAF Images
n=61 eyes
200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm)
|
Clarus - Green
133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm)
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|---|---|---|---|---|
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Number of Eyes With Greater Than 10% Difference in Geographic Atrophy Area Than Heidelberg RegionFinder
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11 eyes
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23 eyes
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24 eyes
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—
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SECONDARY outcome
Timeframe: Up to 75 minutesThe presence of atrophy outside field 2 will be documented from the two ultrawide field imaging devices
Outcome measures
| Measure |
Heidelberg RegionFinder
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
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Heidelberg Manual
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Optos Ultrawide Field FAF Images
200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm)
|
Clarus - Green
133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm)
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|---|---|---|---|---|
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Prevalence of Atrophy Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images
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4 eyes
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4 eyes
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—
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—
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SECONDARY outcome
Timeframe: Up to 75 minutesThe presence of abnormal autofluorescence outside field 2 will be documented from the two ultrawide field imaging devices
Outcome measures
| Measure |
Heidelberg RegionFinder
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Heidelberg Manual
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Optos Ultrawide Field FAF Images
200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm)
|
Clarus - Green
133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm)
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|---|---|---|---|---|
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Prevalence of Other Autofluorescence Abnormalities Outside the Standard 30 Degrees in Clarus and Optos Ultrawide Field Images
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3 eyes
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3 eyes
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—
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 75 minutesPopulation: Participants (and eyes) with data available for pairwise comparison
Outcome measures
| Measure |
Heidelberg RegionFinder
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Heidelberg Manual
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Optos Ultrawide Field FAF Images
n=61 eyes
200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm)
|
Clarus - Green
133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm)
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|---|---|---|---|---|
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Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality
Subfoveal
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29 eyes
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28 eyes
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33 eyes
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—
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Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality
Multifocal
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46 eyes
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46 eyes
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47 eyes
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—
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Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality
Reticular pseudodrusen
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35 eyes
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19 eyes
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33 eyes
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 75 minutesPopulation: Participants (and eyes) with data available for pairwise comparison
Outcome measures
| Measure |
Heidelberg RegionFinder
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Heidelberg Manual
n=61 eyes
Spectralis FAF: 30 degree field of view, 488 excitation wavelength (nm), 500 emission filter (nm)
|
Optos Ultrawide Field FAF Images
n=61 eyes
200 degree field of view, 532, 633 excitation wavelength (nm), 540 emission filter (nm)
|
Clarus - Green
133 degree field of view, 500-585 excitation wavelength (nm), 630-750 emission filter (nm)
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|---|---|---|---|---|
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Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality: Junctional Zone Pattern
None
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1 eyes
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3 eyes
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2 eyes
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—
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Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality: Junctional Zone Pattern
Focal
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5 eyes
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6 eyes
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6 eyes
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—
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Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality: Junctional Zone Pattern
Patchy
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5 eyes
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1 eyes
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1 eyes
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—
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Geographic Atrophy Characteristics at Baseline Visit for Each Imaging Modality: Junctional Zone Pattern
Banded/Diffuse
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50 eyes
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51 eyes
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52 eyes
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—
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Adverse Events
Heidelberg Standard Field
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Optos Ultrawide Field FAF Images
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clarus - Green
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amitha Domalpally, MD, PhD
University of Wisconsin School of Medicine and Public Health
Phone: (608) 262-1334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place