Trial Outcomes & Findings for RETeval Study for Diabetic Retinopathy (NCT NCT01950663)
NCT ID: NCT01950663
Last Updated: 2017-06-12
Results Overview
Accuracy will be reported as count of participants with referral status correctly identified, sensitivity, and specificity, with ETDRS photography and reading as the gold standard.
COMPLETED
NA
468 participants
During a single visit, implicit time, measured by the RETeval device, and ETDRS photography, will be performed to support the analysis of the accuracy of the RETeval device.
2017-06-12
Participant Flow
Participant milestones
| Measure |
RETeval
RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
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|---|---|
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Overall Study
STARTED
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468
|
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Overall Study
COMPLETED
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467
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RETeval Study for Diabetic Retinopathy
Baseline characteristics by cohort
| Measure |
RETeval
n=467 Participants
RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
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|---|---|
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Age, Continuous
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61 years
STANDARD_DEVIATION 11 • n=99 Participants
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Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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409 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
458 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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24 Participants
n=99 Participants
|
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Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
184 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
243 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=99 Participants
|
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Region of Enrollment
United States
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467 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During a single visit, implicit time, measured by the RETeval device, and ETDRS photography, will be performed to support the analysis of the accuracy of the RETeval device.Population: Participants with gradeable fundus photos and RETeval measurements
Accuracy will be reported as count of participants with referral status correctly identified, sensitivity, and specificity, with ETDRS photography and reading as the gold standard.
Outcome measures
| Measure |
RETeval
n=401 Participants
RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
|
|---|---|
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Per Patient Referral Accuracy
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318 Participants
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Adverse Events
RETeval
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stephen R. Fransen
Dean McGee Eye Institute / University of Oklahoma Health Sciences Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place