RECRUITING

Assessment of Retinal Fundus Imaging Camera

Conditions

Diabetic Retinopathy Diabetic Macular Edema

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy per ETDRS level 35 and higher with or without macular edema.

Official Title

Assessment of Retinal Fundus Imaging Camera

Quick Facts

Study Start:2023-11-20

Study Completion:2024-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06173232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 22 years of age or older. * 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.	* Currently participating in an interventional eye study (e.g., actively receiving the investigational product for Diabetic Retinopathy (DR) and/or Diabetic Macular Edema (DME)). * 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

Inclusion Criteria

Exclusion Criteria

* 22 years of age or older.
* 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.

* Currently participating in an interventional eye study (e.g., actively receiving the investigational product for Diabetic Retinopathy (DR) and/or Diabetic Macular Edema (DME)).
* 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

Contacts and Locations

Study Contact

Breanne MacMillan, MS

CONTACT

815-931-1354

macmillan@digitaldiagnostics.com

Principal Investigator

Audrey Singh, BS

STUDY_DIRECTOR

Digital Diagnostics, Inc.

Study Locations (Sites)

Midwest Eye Center

Cincinnati, Ohio, 45202

United States

Collaborators and Investigators

Sponsor: Digital Diagnostics, Inc.

Audrey Singh, BS, STUDY_DIRECTOR, Digital Diagnostics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-20

Study Completion Date2024-05

Study Record Updates

Study Start Date2023-11-20

Study Completion Date2024-05

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Retinopathy
Diabetic Macular Edema