WP06 Retinal microvascular endpoints


 

Work Package Lead: Prof. José Carlos Pastor

06. UNIVERSIDAD DE VALLADOLID – UVA (ES)

 

Objectives:

  • Maintain the general database where all the images will be stored.
  • Train the photographers of each centre involved in the study in the capture and management of the software.
  • Develop web-based tools for the certification of the photographers.
  • Establish the protocol for the screening of diabetic retinopathy.
  • Act as the reading centre for retinal images.
  • Correlate biomarkers of diabetic retinopathy with the level of the disease.

 

Main tasks:

1. The IOBA, located at the University of Valladolid, will be the reading centre for the screening of diabetic retinopathy in the project and the entity responsible for the establishment of the protocol designed for the follow up.
All data will be collected using accepted technological standards and norms and with the guarantee of the privacy of the participants.

  • The spin off ediagnostic ophthalmologia will provide the PACS and the technological support to the participant centres necessary to accumulate digital retinal images from a variety of non mydriatic camera sources and to work under the standard DICOM.
  • This system will use a secure central server to store digital retinal images and relevant patient data and will provide IDs and passwords that provide access to the patient database for each particular centre.

2. The IOBA will be also responsible for the training and certification of the photographers involved in the study in order to guarantee the adequate quality of the fundus photographs for the grading process. Only certificated photographers will be allowed to enter the images in the system. This will be done in two steps:

  • one on-site session.
  • and on line (available during all the study in the virtual campus of the university of Valladolid).

3. e-Diagnostic ophthalmology will provide the centres immediate responses about the quality of the images and the quality for grading.
4. Experts in diabetic retinopathy of the IOBA will grade retinal lesions using a grading system based in the ETDRS scale in order to detect any retinopathy and will evaluate the presence and severity of the retinal lesions associated with diabetic retinopathy.

  • For this purpose two certificated graders will grade each lesion type separately in each eye using an online grading template in order to establish the presence or nor of the retinopathy and the severity in the study population at the beginning, at three years and at the end of the study and to facilitate the report to the participant centres.
  • Reports about the level of diabetic retinopathy of each patient will be provided in 24 hours to the appropriate centre and also stored by e-diagnostic ophthalmology even after the clinical trial should be finished according to legal requirements.

5. The IOBA will provide a final report with the results of grading and progression of retinal lesions and its correlation with the selected biomarkers of diabetic retinopathy.

 

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