Computer-based Screening for Diabetic Retinopathy

NCT01614327 | Completed

• 2 other identifiers: EY18280-042R44EY018280-04
• Study Type: observational
• Target: 19,199
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetic Retinopathy

Keywords

Diabetes Type One; Diabetes Type Two; PreDiabetes; Retinal Screening; RiskAnalyzer; Retinal Imaging; Algorithm; Diabetic Retinopathy; Microaneurysms; Neovascularization; Intraretinal microvascular abnormalities

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of retinal screening for risk stratification of DR using digital fundus photographs with and without the assistance of the RiskAnalyzer.

  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).

  24 months

Secondary Outcomes (1)

• Sensitivity and specificity of retinal screening for risk stratification of DR using digital fundus photographs and the RiskAnalyzer

  24 months

Study Arms (1)

Retinal Screening; Diabetes 1 and 2

Patients diagnosed as either having Pre-Diabetes, Diabetes 1 or Diabetes 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinics in the Southwest serving a Diabetic Community

You may qualify if:

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

You may not qualify if:

• People not diagnosed with either PreDiabetes or Diabetes type 1 or type 2

Sponsors & Collaborators

• VisionQuest Biomedical LLC: lead
• Project Extension for Community Healthcare Outcomes (ECHO): collaborator
• Communicare Health Centers of San Antonio: collaborator
• Retinal Institute of South Texas: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (2)

Project ECHO

Albuquerque, New Mexico, 87102, United States

Location

CommuniCare Health Centers of San Antonio

San Antonio, Texas, 78207, United States

Location

Related Publications (21)

• Griffith SP, Freeman WL, Shaw CJ, Mitchell WH, Olden CR, Figgs LD, Kinyoun JL, Underwood DL, Will JC. Screening for diabetic retinopathy in a clinical setting: a comparison of direct ophthalmoscopy by primary care physicians with fundus photography. J Fam Pract. 1993 Jul;37(1):49-56.

  PMID: 8345340 BACKGROUND

• Williams GA, Scott IU, Haller JA, Maguire AM, Marcus D, McDonald HR. Single-field fundus photography for diabetic retinopathy screening: a report by the American Academy of Ophthalmology. Ophthalmology. 2004 May;111(5):1055-62. doi: 10.1016/j.ophtha.2004.02.004.

  PMID: 15121388 BACKGROUND

• Lin DY, Blumenkranz MS, Brothers RJ, Grosvenor DM. The sensitivity and specificity of single-field nonmydriatic monochromatic digital fundus photography with remote image interpretation for diabetic retinopathy screening: a comparison with ophthalmoscopy and standardized mydriatic color photography. Am J Ophthalmol. 2002 Aug;134(2):204-13. doi: 10.1016/s0002-9394(02)01522-2.

  PMID: 12140027 BACKGROUND

• Boucher MC, Gresset JA, Angioi K, Olivier S. Effectiveness and safety of screening for diabetic retinopathy with two nonmydriatic digital images compared with the seven standard stereoscopic photographic fields. Can J Ophthalmol. 2003 Dec;38(7):557-68. doi: 10.1016/s0008-4182(03)80109-6.

  PMID: 14740797 BACKGROUND

• Jones CD, Greenwood RH, Misra A, Bachmann MO. Incidence and progression of diabetic retinopathy during 17 years of a population-based screening program in England. Diabetes Care. 2012 Mar;35(3):592-6. doi: 10.2337/dc11-0943. Epub 2012 Jan 25.

  PMID: 22279031 BACKGROUND

• Agurto C, Murray V, Barriga E, Murillo S, Pattichis M, Davis H, Russell S, Abramoff M, Soliz P. Multiscale AM-FM methods for diabetic retinopathy lesion detection. IEEE Trans Med Imaging. 2010 Feb;29(2):502-12. doi: 10.1109/TMI.2009.2037146.

  PMID: 20129850 BACKGROUND

• Agurto C, Barriga ES, Murray V, Nemeth S, Crammer R, Bauman W, Zamora G, Pattichis MS, Soliz P. Automatic detection of diabetic retinopathy and age-related macular degeneration in digital fundus images. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5862-71. doi: 10.1167/iovs.10-7075.

  PMID: 21666234 BACKGROUND

• Larsen M, Godt J, Larsen N, Lund-Andersen H, Sjolie AK, Agardh E, Kalm H, Grunkin M, Owens DR. Automated detection of fundus photographic red lesions in diabetic retinopathy. Invest Ophthalmol Vis Sci. 2003 Feb;44(2):761-6. doi: 10.1167/iovs.02-0418.

  PMID: 12556411 BACKGROUND

• Niemeijer M, van Ginneken B, Russell SR, Suttorp-Schulten MS, Abramoff MD. Automated detection and differentiation of drusen, exudates, and cotton-wool spots in digital color fundus photographs for diabetic retinopathy diagnosis. Invest Ophthalmol Vis Sci. 2007 May;48(5):2260-7. doi: 10.1167/iovs.06-0996.

  PMID: 17460289 BACKGROUND

• Niemeijer M, van Ginneken B, Staal J, Suttorp-Schulten MS, Abramoff MD. Automatic detection of red lesions in digital color fundus photographs. IEEE Trans Med Imaging. 2005 May;24(5):584-92. doi: 10.1109/TMI.2005.843738.

  PMID: 15889546 BACKGROUND

• Osareh A, Mirmehdi M, Thomas B, Markham R. Automated identification of diabetic retinal exudates in digital colour images. Br J Ophthalmol. 2003 Oct;87(10):1220-3. doi: 10.1136/bjo.87.10.1220.

  PMID: 14507751 BACKGROUND

• Scotland GS, McNamee P, Philip S, Fleming AD, Goatman KA, Prescott GJ, Fonseca S, Sharp PF, Olson JA. Cost-effectiveness of implementing automated grading within the national screening programme for diabetic retinopathy in Scotland. Br J Ophthalmol. 2007 Nov;91(11):1518-23. doi: 10.1136/bjo.2007.120972. Epub 2007 Jun 21.

  PMID: 17585001 BACKGROUND

• Fleming AD, Philip S, Goatman KA, Williams GJ, Olson JA, Sharp PF. Automated detection of exudates for diabetic retinopathy screening. Phys Med Biol. 2007 Dec 21;52(24):7385-96. doi: 10.1088/0031-9155/52/24/012. Epub 2007 Dec 5.

  PMID: 18065845 BACKGROUND

• Philip S, Fleming AD, Goatman KA, Fonseca S, McNamee P, Scotland GS, Prescott GJ, Sharp PF, Olson JA. The efficacy of automated "disease/no disease" grading for diabetic retinopathy in a systematic screening programme. Br J Ophthalmol. 2007 Nov;91(11):1512-7. doi: 10.1136/bjo.2007.119453. Epub 2007 May 15.

  PMID: 17504851 BACKGROUND

• Abramoff MD, Niemeijer M, Suttorp-Schulten MS, Viergever MA, Russell SR, van Ginneken B. Evaluation of a system for automatic detection of diabetic retinopathy from color fundus photographs in a large population of patients with diabetes. Diabetes Care. 2008 Feb;31(2):193-8. doi: 10.2337/dc07-1312. Epub 2007 Nov 16.

  PMID: 18024852 BACKGROUND

• Bresnick GH, Mukamel DB, Dickinson JC, Cole DR. A screening approach to the surveillance of patients with diabetes for the presence of vision-threatening retinopathy. Ophthalmology. 2000 Jan;107(1):19-24. doi: 10.1016/s0161-6420(99)00010-x.

  PMID: 10647713 BACKGROUND

• Kinyoun JL, Martin DC, Fujimoto WY, Leonetti DL. Ophthalmoscopy versus fundus photographs for detecting and grading diabetic retinopathy. Invest Ophthalmol Vis Sci. 1992 May;33(6):1888-93.

  PMID: 1582794 BACKGROUND

• Pattichis MS, Pattichis CS, Avraam M, Bovik A, Kyriacou K. AM-FM texture segmentation in electron microscopic muscle imaging. IEEE Trans Med Imaging. 2000 Dec;19(12):1253-8. doi: 10.1109/42.897818.

  PMID: 11212374 BACKGROUND

• Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):786-806.

  PMID: 2062513 BACKGROUND

• Harding SP, Broadbent DM, Neoh C, White MC, Vora J. Sensitivity and specificity of photography and direct ophthalmoscopy in screening for sight threatening eye disease: the Liverpool Diabetic Eye Study. BMJ. 1995 Oct 28;311(7013):1131-5. doi: 10.1136/bmj.311.7013.1131.

  PMID: 7580708 BACKGROUND

• Kalm H, Egertsen R, Blohme G. Non-stereo fundus photography as a screening procedure for diabetic retinopathy among patients with type II diabetes. Compared with 60D enhanced slit-lamp examination. Acta Ophthalmol (Copenh). 1989 Oct;67(5):546-53. doi: 10.1111/j.1755-3768.1989.tb04106.x.

  PMID: 2589054 BACKGROUND

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MeSH Terms

Conditions

Diabetic Retinopathy; Prediabetic State; Microaneurysm; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Aneurysm; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilberto Zamora, PhD

  Director of Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 7, 2012
• Study Start: August 1, 2012
• Primary Completion: February 24, 2015
• Study Completion: February 24, 2015
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

US (2)