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Computer-based Screening for Diabetic Retinopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614327
First Posted: June 7, 2012
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Project Extension for Community Healthcare Outcomes (ECHO)
Communicare Health Centers of San Antonio
Retinal Institute of South Texas
National Eye Institute (NEI)
Information provided by (Responsible Party):
VisionQuest Biomedical LLC
  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, receiver operating characteristic (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 ]

    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 ]

    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).



Enrollment: 19199
Study Start Date: August 2012
Study Completion Date: February 24, 2015
Primary Completion Date: February 24, 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614327


Locations
United States, New Mexico
Project ECHO
Albuquerque, New Mexico, United States, 87102
United States, Texas
CommuniCare Health Centers of San Antonio
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
VisionQuest Biomedical LLC
Project Extension for Community Healthcare Outcomes (ECHO)
Communicare Health Centers of San Antonio
Retinal Institute of South Texas
National Eye Institute (NEI)
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 ( U.S. NIH Grant/Contract )
First Submitted: May 24, 2012
First Posted: June 7, 2012
Last Update Posted: September 18, 2017
Last Verified: September 2017

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

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