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Completed No phase listed Observational

OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection

ClinicalTrials.gov ID: NCT06343350

Public ClinicalTrials.gov record NCT06343350. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 18, 2026, 4:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective Pilot Study to Assess the Usability and Feasibility of OPTDR01 as an Automated Diabetic Retinopathy Screening Tool

Study identification

NCT ID
NCT06343350
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Optain Health
Industry
Enrollment
300 participants

Conditions and interventions

Interventions

  • OPTDR01 software application Device

Device

Eligibility (public fields only)

Age range
22 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2024
Primary completion
Oct 5, 2025
Completion
Oct 29, 2025
Last update posted
Feb 26, 2026

2024 – 2025

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
3
Facility City State ZIP Site status
Gastro SB Chula Vista California 91910
Triwest Research Associates San Diego California 92108
Gulf Coast Clinical Research Houston Texas 77070

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06343350, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2026 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06343350 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →