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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Retina Institute of Hawaii
Sponsor:
Information provided by (Responsible Party):
Retina Institute of Hawaii
ClinicalTrials.gov Identifier:
NCT01790945
First received: February 11, 2013
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition
Mild Nonproliferative Diabetic Retinopathy
Moderate Nonproliferative Diabetic Retinopathy
Severe Nonproliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Diabetic Macular Edema

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Diabetic Macular Edema and Diabetic Retinopathy Identification by Screening (Telemed) With Verified Automated Retinal Photography

Resource links provided by NLM:


Further study details as provided by Retina Institute of Hawaii:

Primary Outcome Measures:
  • % change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HgA1C from Primary Care Physician referral to post retinal specialist visit [ Time Frame: six months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Time from PCP referral for patient to see an ophthalmologist and appointment with retinal specialist [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment Study
Population of subjects will have been diagnosed with mild NPDR, Moderate NPDR, Severe NPDR, PDR and DME

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

(n=500) A large population will need to be screened to find 100-150 patients with diabetic eye disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790945

Locations
United States, Hawaii
Craig Kadooka, MD Not yet recruiting
Hilo, Hawaii, United States, 96720
Contact: Debra L Shimabukuro, RN    808-348-9247    deb@retinahawaii.com   
Contact: Anovale Semisi    808-955-0255    anovale@retinahawaii.com   
Sub-Investigator: Craig Kadooka, MD         
Sponsors and Collaborators
Retina Institute of Hawaii
Investigators
Principal Investigator: Michael D Bennett, MD Retina Institute of Hawaii
  More Information

No publications provided

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT01790945     History of Changes
Other Study ID Numbers: DIVER Study
Study First Received: February 11, 2013
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Edema
Macular Edema
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014