Last reviewed · How we verify
NCT05857943
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images
NA trial testing AEYE-DS Software in Diabetes Mellitus in 363 participants. Completed in 10 October 2023.
11 September 2023
Quick facts
| Lead sponsor | AEYE Health Inc |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 363 |
| Start date | 29 March 2023 |
| Primary completion | 11 September 2023 |
| Estimated completion | 10 October 2023 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- AEYE-DS Software
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
Sponsor
AEYE Health Inc
Who can join
22 and older, any sex, with Diabetes Mellitus or Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using AI-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05857943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AEYE-DS Software
Trials testing the same drug.
- NCT06241664 — Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Di · NA · completed
Other recruiting trials for Diabetes Mellitus
Currently open trials in the same condition.
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- NCT07425275 — Integrated Oral Care Intervention for Xerostomia in Diabetes Patients · NA · recruiting
- NCT06918977 — Improving Glycemic Control With Telemedicine and Smart Insulin Pens · NA · recruiting
Other AEYE Health Inc trials
Trials by the same sponsor.
- NCT06241664 — Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Di · NA · completed
- NCT04612868 — Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Image · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05857943 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AEYE Health Inc
- Last refreshed: 8 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05857943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing