3 completed, 1 active not recruiting, 1 recruiting, 1 unknown. 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy SaMD intended for the detection of diabetic retinopathy in adults with diabetes., An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes. - Diabetic Retinopathy (DR) | Recruiting | Digital Diagnostics, Inc. | 800 | 2026-08-24 | 2026-09-28 | |
| Assessment of Retinal Fundus Imaging Camera Camera Imaging - Diabetic Retinopathy, Diabetic Macular Edema | Unknown | Digital Diagnostics, Inc. | 100 | 2023-11-20 | 2023-12-15 | |
| Camera Qualification Study handheld fundus camera - Diabetic Retinopathy | Active not recruiting | Digital Diagnostics, Inc. | 626 | 2023-03-03 | 2024-10-22 | |
| Bangladesh PRODUCTIVity in Eyecare Trial Results utilized from autonomous AI diagnostic system for diabetic retinopathy and/or diabetic macular edema - Diabetic Retinopathy, Diabetic Macular Edema | Not applicable | Completed | Orbis | 993 | 2022-03-20 | 2024-02-06 |
| A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy LumineticsCore (formerly IDX-DR) - Diabetic Retinopathy | Completed | Digital Diagnostics, Inc. | 900 | 2017-01-01 | 2024-03-07 | |
| Computer Detection of Diabetic Retinopathy Compared to Clinical Examination Photography of the retina, Retinal photography - Diabetic Retinopathy | Completed | Digital Diagnostics, Inc. | 600 | 2012-04-01 | 2014-04-22 |
United States (4) · Bangladesh (1)
Audrey Singh, BS (1) · Brian Privett, MD (1) · James Major, MD (1) · Jordan Graff, MD (1) · Judianne Kellaway, MD (1) · Michael Abramnoff, MD, PhD (1) · Nathan Congdon, MD, MPH (1) · Timothy Johnson, MD (1)