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CORC // Coimbra Ophthalmology Reading Centre


The Coimbra Ophthalmology Reading Centre (CORC) focus its activities in grading fundus images and OCT images of the retina, as well as functional evaluations of the retina using mfERG and visual fields.

It serves as central Reading Centre for a series of clinical trials, mainly in Diabetic Retinopathy (DR) and Age-related Macular Degeneration (AMD).

CORC is also the central Reading Centre for the Diabetic Retinopathy Screening Programme of the Central Region of Portugal since 2011.

CORC has dedicated staff composed by the CORC Director, a Management Team involving Project Managers, Grading Supervisors and an Administrative Coordinator, a Grading Team of 26 graders (15 medical graders, 4 orthoptist graders and 7 technical graders) and a Secretariat Team involving general secretariat and study coordinators.

 

Quality System

CORC is certified, since 2013, according to the international standard ISO 9001 - Requirements of a Quality Management System for the activity of Grading of Eye Exams.

CORC activities are performed in accordance with internal Standard Operating Procedures (SOPs) which are elaborated in compliance with the ICH Guidelines for Good Clinical Practice (ICH-GCP) and ISO 9001.

 

Information Technology Systems

CORC has a secure custom-designed web based tool to transmit images between Clinical Sites and CORC. This system is hosted in the AIBILI´s Data Centre .

For grading purposes CORC uses licensed software from the equipment suppliers, such as Cirrus HD-OCT (Carl Zeiss Meditec), Heidelberg Eye Explorer (Heidelberg Engineering), RETIsystem (Roland Consult), Topcon 3D-OCT (Topcon Coorporation), etc.

For research purposes CORC also has novel software programmes, developed in-house, to reliably quantify neovascularization of the retina and leakage, assess microaneurysm turnover in diabetic patients (RetmarkerDR®), classify and quantify AMD lesions and disease activity in patients with AMD (RetmarkerAMD® Research) and perform segmentation of the retinal layers on OCT.

 

Summary - Main Grading Activities

Diabetic Retinopathy (DR)

  • CFP: ETDRS/DR Grading; Automated microaneurysm assessment (RetmarkerDR®); Screening DR
  • CFP/FA: Classification/quantification of DR characteristics, including proliferative DR and diabetic macular edema; High-risk Proliferative DR assessment; Quantification of neovascularization, capillary closure and leakage
  • OCT: Retinal Thickness; Retinal Nerve Fiber Layer Thickness; Ganglion Cell Layer Thickness; Presence and location of key features for DR; Segmentation analysis of the retinal layers; Quantification of cysts
  • mfERG: Amplitude/Implicit time of P1 & Z-score analysis

Age-related Macular Degeneration (AMD)

  • CFP/FA/ICG/FAF: Classification/quantification of ARM/AMD lesions (RetmarkerAMD Research); Classification/quantification of Polipoydal Choroidal Vasculopathy / AMD characteristics
  • OCT: Retinal Thickness; Presence and location of key features for AMD

Retinitis Pigmentosa (RP)

  • CFP/VF/OCT/FAF: Retinal Thickness and total volume; Presence and location of key features for RP; Area of functioning retina

 (CFP – Color Fundus Photography; FA – Fluorescein Angiography; FAF – Fundus Autofluorescence; ICG - Indocyanine Green Angiography; mfERG – multifocal Electroretinography; OCT – Optical Coherence Tomography; VF – Visual Fields)

Services

  • Development and provision of study-specific Acquisition Protocols
  • Technicians training and certification
  • Equipment certification
  • Web-based platform for exams’ submission
  • Development and application of study-specific Grading Protocols
  • Grading of ophthalmic exams (retinal fundus images, OCT, mfERG, …) by trained graders for characterization and quantification of ophthalmic disease
  • Eligibility review services
  • Management and  monitoring of exams received and results
  • Provides data backup procedures and a disaster recovery plan
  • Provides secure long-term archiving of study materials , both digital and hardcopy
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