Diabetic Macular Edema and Diabetic Retinopathy Screening (TeleMed) With Automated Retinal Photography

• Conditions: Mild Nonproliferative Diabetic Retinopathy; Moderate Nonproliferative Diabetic Retinopathy; Severe Nonproliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy; Diabetic Macular Edema

• Registration Number: NCT01790945
• Lead Sponsor: Retina Institute of Hawaii

Brief Summary

The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.

Detailed Description

Retina Institute of Hawaii will place an infrastructure to screen for diabetic retinopathy/diabetic macular edema in 5 of the states largest Primary Care Clinics, General Medical and or Endocrine practices which re our primary referrals for diabetes patients. Each Sub-site will receive a DRS Automated Retinal Camera and our staff will train the sub-site's staff on taking images. The submission of these images to our practice will be administered by an automated job scheduler in the DRS Automated Retinal Camera removing the requirement of the locations to send images. Images will be electronically uploaded and sent to the Retina Institute of Hawaii for detailed interpretation and report sent back to the patients, their diabetes care MD's and their nurse practitioners/diabetic educators.

Study Timeline

• Status Verified: 2013-02
• Study Start: 2013-02
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-12
• Last Update Submitted: 2013-02-12
• Study First Posted: 2013-02-13
• Last Update Posted: 2013-02-13
• Primary Completion: 2013-06
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients diagnosed with diabetes that have not seen an Ophthalmologist in the past 1 year

Exclusion Criteria

• Patients with diabetes already under the care of an Ophthalmologist.
• Patient not willing to give Consent for participation in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system	6 months

Secondary Outcome Measures

Name	Time	Method
Change in HgA1C from Primary Care Physician referral to post retinal specialist visit	six months

Trial Locations

Locations (1)

Craig Kadooka, MD; 🇺🇸 Hilo, Hawaii, United States