Computer-based Screening for Diabetic Retinopathy

This study is currently recruiting participants.
Verified July 2013 by VisionQuest Biomedical LLC
Sponsor:
Collaborators:
Project Extension for Community Healthcare Outcomes (ECHO)
Communicare Health Centers of San Antonio
Retinal Institute of South Texas
Information provided by (Responsible Party):
VisionQuest Biomedical LLC
ClinicalTrials.gov Identifier:
NCT01614327
First received: May 24, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

The study is an Observational, Phase 0 designed to establish that the risk for diabetic retinopathy assigned by the RiskAnalyzer improves the reading accuracy and consistency of any reader and it decreases the inter-reader variability.

Objectives: Objectives one, two, and three are arranged chronologically and in an increasing level of complexity as a three tiered approach to support the primary and secondary endpoint of the trial. Objective one is to test fully each system components of the study limited to a single site. Objective two is to evaluate the efficacy of the RiskAnalyzer to assign the risk of Diabetic Retinopathy in comparison to the gold standard. Objective three is to demonstrate that the reader's accuracy in grading images is improved when risk levels assigned by the RiskAnalyzer are made available to the reader while performing the grading of the images which is the primary endpoint of the trial Methods and Research Design: A network of clinical study sites will be established to meet the required number of cases needed as calculated by statistical analysis. Male and Female Subjects between the ages of 18-65 who are either pre-diabetic or diabetics will be eligible for participation in this study. Subjects will be recruited, consented, photographed and their images graded by two trained readers and analyzed by the RiskAnalyzer . The risk levels that are obtained from the RiskAnalyzer will be compared to the current gold standard practice, manual grading of each case by a reader. Data collected during this clinical trial will be reported to the referring physician in the form of a retinal screening report completed and signed by a licensed Ophthalmic professional and delivered to their attending physician. Risk levels for diabetic retinopathy obtained by use of the RiskAnalyzer will not be given to the attending physician under any circumstances in order to preserve standard of care for the patient.

The sensitivity, specificity, ROC, and data flow process of the RiskAnalyzer, retinal image reading system will be analyzed and based on the current gold standard of a human reader. This study is a three-aims study, 24 month in length, prospective, case-only study of the performance of the RiskAnalyzer. The risk levels obtained from the RiskAnalyzer are not made visible, i.e. are not unmasked to either of the two readers. In year two, the risk levels obtained from the RiskAnalyzer for half of the studies are unmasked to the two readers while grading the image.

Access to all study data and processes follows a role-based design. The clinical staff will have access only to clinical data but not the technical data. The technical team will have access to the technical data only but not the clinical data. The study coordinator will have access to all data. The use of computers will adhere to the Guidance for Industry Computerized Systems Used in Clinical Investigations and applicable sections of 21 CFRs part 11.


Condition
Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase 0 Observational Study of a Computer-based Screening Algorithm for Detection of Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by VisionQuest Biomedical LLC:

Primary Outcome Measures:
  • Sensitivity and specificity of retinal screening for risk stratification of DR using digital fundus photographs with and without the assistance of the RiskAnalyzer. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Using the gold standard, the sensitivity and specificity are calculated as:

    Sens=TP/(TP+FN) Spec=TN/(TN+FP) Where TP is the number of true positives (DR subjects correctly classified), FN is the number of false negatives (DR subjects incorrectly classified as normal), TN is the number of true negatives (Normal subjects correctly classified), and FP is the number of false positives (Normal subjects incorrectly classified as abnormals).



Secondary Outcome Measures:
  • Sensitivity and specificity of retinal screening for risk stratification of DR using digital fundus photographs and the RiskAnalyzer [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Using the gold standard, the sensitivity and specificity are calculated as:

    Sens=TP/(TP+FN) Spec=TN/(TN+FP) Where TP is the number of true positives (DR subjects correctly classified), FN is the number of false negatives (DR subjects incorrectly classified as normal), TN is the number of true negatives (Normal subjects correctly classified), and FP is the number of false positives (Normal subjects incorrectly classified as abnormals).



Estimated Enrollment: 10000
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Retinal Screening; Diabetes 1 and 2
Patients diagnosed as either having Pre-Diabetes, Diabetes 1 or Diabetes 2

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinics in the Southwest serving a Diabetic Community

Criteria

Inclusion Criteria:

  • Patients over the age of 18
  • Patients diagnosed as with either PreDiabetes or Diabetes type 1 or type 2

Exclusion Criteria:

  • People not diagnosed with either PreDiabetes or Diabetes type 1 or type 2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614327

Contacts
Contact: Richard VanNess, MS 505-508-1994 ext 1016 rvanness@visionquest-bio.com
Contact: Elizabeth McGrew, BA 505-508-1994 ext 1017 emcgrew@visionquest-bio.com

Locations
United States, New Mexico
Project ECHO Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Kathleen Colleran, MD    505-272-6542    kcolleran@salud.unm.edu   
Contact: Erica Harding, MA    505-272-6542    Eharding@salud.unm.edu   
Principal Investigator: Kathleen Colleran, MD         
United States, Texas
CommuniCare Health Centers of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Son Nguyen, MD    210-233-7000    dr.snguyen@CommuniCareSa.org   
Contact: Paul Nguyen    210-233-7000    pnguyen@CommuniCareSa.org   
Principal Investigator: Son Nyugen, MD         
Sponsors and Collaborators
VisionQuest Biomedical LLC
Project Extension for Community Healthcare Outcomes (ECHO)
Communicare Health Centers of San Antonio
Retinal Institute of South Texas
Investigators
Study Director: Gilberto Zamora, PhD Director of Clinical Operations
  More Information

Additional Information:
Publications:

Responsible Party: VisionQuest Biomedical LLC
ClinicalTrials.gov Identifier: NCT01614327     History of Changes
Other Study ID Numbers: EY18280-04, 2R44EY018280-04
Study First Received: May 24, 2012
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by VisionQuest Biomedical LLC:
Diabetic Retinopathy
Diabetes Type One
Diabetes Type Two
PreDiabetes
Retinal Screening
RiskAnalyzer
Retinal Imaging
Algorithm
Microaneurysms
Neovascularization
Intraretinal microvascular abnormalities

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014