Clinical Trials Directory

Trials / Completed

CompletedNCT03078231

Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

Status
Completed
Phase
Study type
Observational
Enrollment
52 (actual)
Sponsor
Eyenuk, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers

Summary

More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or 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 injections 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. This study is designed to assess the performance of EyeArt, an automated DR screening tool.

Conditions

Interventions

TypeNameDescription
PROCEDUREColor fundus photographySubjects will undergo fundus photography before and after administration of mydriatic agent.
DRUGMydriatic AgentSubjects will be administered mydriatic medication to dilate their pupils.

Timeline

Start date
2017-02-17
Primary completion
2017-04-24
Completion
2017-04-24
First posted
2017-03-13
Last updated
2018-07-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03078231. Inclusion in this directory is not an endorsement.