A clinical study to collect Optical Coherence Tomography (OCT) Angiography data from patients with a confirmed diagnosis of diabetes who are being scanned on the ZEISS PLEX Elite 9000 OCT Angiography device for diabetic retinopathy assessment.

Principal Investigator & Study Site: Dr. Aditya Shreekant Kelkar, Medical Director & specialist in cataract surgery National Institute of Ophthalmology, 

376, Sind Society, Bremen Square, Ganesh Khind Road, Aundh, Pune - 411007

Study Design: A single center, prospective study, in which eligible patients with confirmed diagnosis of Diabetes will be required to undergo imaging on the ZEISS PLEX Elite 9000 OCTA device as per the site standard operating procedures for assessment of DR. Diabetic patients will be recruited, screened for eligibility, and informed consent will be obtained from those who meet the screening criteria. The OCTA data from ZEISS PLEX Elite 9000 OCT Angiography device along with demographic data and Clinical data will be collected. The data will be collected in an anonymized form, from patients with confirmed diagnosis of diabetes as per the requirements mentioned in Annexure I, who are being managed for diabetic retinopathy. The data will be collected from patients who have consented to provide their angiography data and clinical data for use of research and development purposes. The Principal Investigator shall ensure that the patient’s consent is obtained before the data is collected from the patient. OCTA data from following scanning protocols will be collected: 15x15 mm and/or 15x9 mm as per the site’s SOP for imaging on ZEISS PLEX Elite 9000 device. The distribution for 15x15 mm and 15x9 mm datasets has been provided in the Annexure I. In case, a patient exhibits diabetic retinopathy in both eyes, the OCTA cube from each eye will be included in the patient’s dataset. One OCTA data export per eye will be gathered from each patient. The assessment will involve a review of each patient’s data to ensure image quality criteria, the Sponsor’s representative will notify the Principal investigator about the image quality control measures. The conclusion of the study will be determined by the last dataset transferred by the investigator, which undergoes review and approval by the Sponsor for inclusion in the study. It is recommended that the gender distribution is uniform to avoid any skewness in the data. The demographic parameters must be collected and populated as provided in the case record form.

Inclusion criteria:

a. Male or female patients aged 18 years and above with confirmed diagnosis of Type 1 and Type 2 Diabetes

b. Patients who consent to share their data for research and development purposes.

c. Patients with the following stages of DR and the respective distribution: • No DR (15%) • Mild NPDR (25%) • Moderate NPDR (25%) • Severe NPDR (25%) • Proliferative DR (10%) Within the dataset of various DR stages, a small subset of the data shall fulfil the following. criterion: • Presence of Diabetic Macular Edema (DME) (5%)

Exclusion criteria:

a. Patients who have not consented to share their data for research and development purposes.

b. Known history (in last 6 months from date of acquisition) of retinal artery or vein occlusion.