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NCT03112005
Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
trial testing Color fundus photography in Diabetic Retinopathy in 942 participants. Completed in 31 May 2018.
31 May 2018
Quick facts
| Lead sponsor | Eyenuk, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 942 |
| Start date | 17 April 2017 |
| Primary completion | 31 May 2018 |
| Estimated completion | 31 May 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Color fundus photography
- Mydriatic Agent — full drug profile →
Conditions studied
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
- Diabetic Eye Problems — all drugs for Diabetic Eye Problems →
- Diabetic Macular Edema — all drugs for Diabetic Macular Edema →
Sponsor
Eyenuk, Inc. — full company profile →
Who can join
18 and older, any sex, with Diabetic Retinopathy or Diabetic Eye Problems. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF treatment if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. EyeArt is an automated screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DED. This study is designed to assess the safety and efficacy of EyeArt.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pivotal Evaluation of an Artificial Intelligence System for Autonomous Detection of Referrable and Vision-Threatening Diabetic Retinopathy.
Ipp E, Liljenquist D, Bode B, Shah VN, et al · · 2021 · cited 146× · PMID 34779843 · DOI 10.1001/jamanetworkopen.2021.34254 -
Artificial Intelligence Detection of Diabetic Retinopathy: Subgroup Comparison of the EyeArt System with Ophthalmologists' Dilated Examinations.
Lim JI, Regillo CD, Sadda SR, Ipp E, et al · · 2023 · cited 80× · PMID 36345378 · DOI 10.1016/j.xops.2022.100228
Verify or expand the search:
- PubMed search for NCT03112005
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Color fundus photography
Trials testing the same drug.
- NCT04302012 — Assessment of EyeArt Performance With Retinal Imaging Devices · completed
- NCT03078231 — Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool · completed
Other recruiting trials for Diabetic Retinopathy
Currently open trials in the same condition.
- NCT07255326 — Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes · NA · recruiting
- NCT06782997 — Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diab · recruiting
- NCT07002372 — Effect of Video Viewing on Intravitreal Injection Experience · NA · recruiting
- NCT06713720 — Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy · NA · recruiting
- NCT06892353 — AI-Powered DIY Screening System for Diabetic Retinopathy · NA · recruiting
Other Eyenuk, Inc. trials
Trials by the same sponsor.
- NCT04984200 — Assessment of EyeArt Performance With Retinal Cameras · completed
- NCT04302012 — Assessment of EyeArt Performance With Retinal Imaging Devices · completed
- NCT03078231 — Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool · 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 NCT03112005 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eyenuk, Inc.
- Last refreshed: 30 July 2018
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/NCT03112005.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing