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

Diabetic Macular Edema Clinical Trial

— DIVER  

Official title:

Diabetic Macular Edema and Diabetic Retinopathy Identification by Screening (Telemed) With Verified Automated Retinal Photography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01790945
• Other study ID #: DIVER Study
• Status: Not yet recruiting
• Phase: N/A
• First received: February 11, 2013
• Last updated: February 12, 2013
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: February 2013
• Source: Retina Institute of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Mild Nonproliferative Diabetic Retinopathy
• Moderate Nonproliferative Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Severe Nonproliferative Diabetic Retinopathy

Locations

Country	Name	City	State
United States	Craig Kadooka, MD	Hilo	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Retina Institute of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from PCP referral for patient to see an ophthalmologist and appointment with retinal specialist		6 months	No
Primary	% change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system		6 months	No
Secondary	Change in HgA1C from Primary Care Physician referral to post retinal specialist visit		six months	No