Retinal Care Data Repository

Sponsor
Retinal Care Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04794907
Collaborator
(none)
1,000
101

Study Details

Study Description

Brief Summary

The Retinal Care Data Repository's primary objective is to make data available for Retinal Care to develop algorithms that improve the care of people with retinal diseases.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation

Detailed Description

The initial focus is to develop algorithms that prevent, delay the progression, or improve treatment of diabetic retinopathy (DR) and age-related macular degeneration (AMD). Examples include but are not limited to: describing the incidence, prevalence, and severity distribution of DR and AMD in the overall population and subgroups; diagnosing specified severity thresholds for DR and AMD; predicting the development and progression of DR and AMD for the overall population, subgroups, and individuals; and recommending tests and treatments to prevent or delay the progression of DR and AMD for the overall population, subgroups, and individuals.

Data will be collected retrospectively and prospectively.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Retinal Care Data Repository
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2030
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

Arm Intervention/Treatment
DR

Patients with diabetes

Other: Observation
Patient data will be collected from eye exams, surveys and medical record review.

AMD

Patients age 55 and older

Other: Observation
Patient data will be collected from eye exams, surveys and medical record review.

Outcome Measures

Primary Outcome Measures

  1. Risk Stratification [Decade]

    Predict the participant's risk of developing specific severity levels of DR and AMD

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 100 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Diabetes or age 65 years and older
Exclusion Criteria:
  • None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Retinal Care Inc.

Investigators

  • Principal Investigator: Stephen R Fransen, Retinal Care Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Retinal Care Inc.
ClinicalTrials.gov Identifier:
NCT04794907
Other Study ID Numbers:
  • 10-PLN-003
First Posted:
Mar 12, 2021
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022