EYE DMI
Research type
Research Study
Full title
Epidemiological Study to Evaluate the Prevalence and Progression of Diabetic Macular Ischemia in Patients with Diabetic Retinopathy Treated with Panretinal Photocoagulation.
IRAS ID
282693
Contact name
Peter Scanlon
Contact email
Sponsor organisation
Boehringer Ingelheim
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
This is a non-interventional, epidemiological, prospective, multi center study being conducted in up to 6 countries. The goal of the study will be to provide an estimate of the occurrence of Diabetic Macular Ischemia (eye condition caused by loss of blood flow in the part of the eye called the "retina") in patients with Diabetic Retinopathy (the most common diabetic eye condition) and who have been treated with panretinal photocoagulation (laser that is used to treat Diabetic Retinopathy). In addition, to analyse changes in the eye and vision for eligible patients throughout a 12 month follow up period.
There will be a part A and B to the study. Part A will focus on collecting eye assessment data from patients during the baseline period while part B will be about following up of eligible patients for 12 months to evaluate changes in the eye and vision. The follow up visits will be part of routine clinical practice. A variety of techniques such as Optical Coherence Angiography Tomography and Spectral Domain Optical Coherence Tomography (both are non-invasive imaging techniques developed to look at the blood vessels in the eye) will be used to help evaluate the changes in eye/eyes throughout the 12 month follow up period for patients with Diabetic Macular Ischemia. Furthermore, changes in visual acuity under normal and low-luminance will be also analyzed throughout the follow up for part B.
Patients will be selected based on their adherence to the inclusion criteria. Data will be collected from medical records and entered into an Electronic Data Capture system through completion of electronic case report forms.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0182
Date of REC Opinion
1 Sep 2020
REC opinion
Further Information Favourable Opinion