A retrospective optical coherence tomography angiography data collection study in patients with confirmed diagnosis of diabetes who have undergone scanning on ZEISS CIRRUS HD-OCT 5000 device for assessment of diabetic retinopathy.

Principal Investigator (PI) and Study Site:

Dr. Debdulal Chakraborty Senior Consultant,

Disha Eye Hospital,

Grand Trunk Road,

Sheoraphuli. West Bengal – 712223.

Study Design: This is a single centre, retrospective data collection study and will undergo approval process by ethics committee of the study sites, prior to study initiation. The study will involve collection of OCTA image data, specifically the native exports, from ZEISS CIRRUS HD-OCT 5000 device along with clinical and demographic parameters from patients with confirmed diagnosis of diabetes as per the data requirement and image quality guidelines. The data will be collected from patients who had consented for use of clinical data for medical research and development purposes as per the site’s standard patient registration process. The Principal Investigator shall be responsible for ensuring that the patient consent was available at their site before the data collection is initiated. OCTA data from following Angio Scanning protocol will be collected: 6 x 6 mm. Before the transfer of data, Principal Investigator shall ensure that the data is anonymized through the Omit Patient Identifiers feature available on the ZEISS CIRRUS HD-OCT 5000 device. In case, a patient exhibits diabetic retinopathy in both eyes, the OCTA from each eye will be included in the patient’s dataset. One OCTA data export per eye will be gathered from each patient. In cases where multiple scans are accessible from various visits for a single patient, the data will be obtained from visits separated by at least a 6-month interval. For each visit, OCTA data meeting the specified data requirements and image quality criteria outlined in Annexure I will be collected. The assessment will involve a review of each patient’s data to ensure both image quality and data completeness. If the dataset fails to meet the specified data requirements and image quality criteria, the Sponsor’s representative will notify the investigator about the image quality control measures. The conclusion of the study will be determined by the last dataset transferred by the investigator, which has undergone review and approval by the Sponsor for inclusion in the study. The demographic parameters must be collected and populated as provided in the case record sheet .

Inclusion criteria:

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

2. Patients who had consented to share their data for research and development purposes. 3. Patients with 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:

1. Patients who had not consented to share their data for research and development purposes.

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