Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
100 participants
OBSERVATIONAL
2023-11-20
2024-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Subjects with ETDRS ≥ 35 with or without DME
Camera Imaging
Camera Imaging
Group 2
Subjects with ETDRS 20 or less and no DME
Camera Imaging
Camera Imaging
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Camera Imaging
Camera Imaging
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented diagnosis of diabetes mellitus, as per any of the following: Having met the criteria established by the World Health Organization (WHO) and/or the American Diabetes Association (ADA), Hemoglobin A1c (HbA1c) ≥ 6.5%, Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L), Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75g anhydrous glucose dose dissolved in water, Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
* Ability to understand and the willingness to sign a written informed consent document.
* Diagnosis from a retinal specialist of ETDRS level of 35 or higher with or without DME or diagnosis from a retinal specialist of ETDRS level 20 or lower and no DME.
* Standard Corrected Visual Acuity of at least 20/40 or better in both eyes.
Exclusion Criteria
* Has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia, or previous enucleation).
* Pregnancy
* Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops.
* Any condition that is contraindicated for the use of study devices in the opinion of the investigator.
* Contraindication for imaging by devices used in the study due to any of the following:
* Subject is hypersensitive to light
* Subject recently underwent photodynamic therapy (PDT)
* Subject is taking medication that causes photosensitivity
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Digital Diagnostics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Audrey Singh, BS
Role: STUDY_DIRECTOR
Digital Diagnostics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Midwest Eye Center
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Savannah Hollingsworth
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO-CLN-001
Identifier Type: -
Identifier Source: org_study_id