Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062125) titled 'Retinal Oxygen Saturation in Chorioretinal Diseases' on July 2.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Kagawa University

Condition: Condition - chorioretinal disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In this study, we will measure retinal tissue oxygen saturation using Zilia during fundus examinations in patients with abnormalities in the fundus, such as diabetic retinopathy, retinal vein occlusion, age-related macular degeneration, retinal detachment, epiretinal membrane, high myopia, and glaucoma. We will measure retinal oxygen saturation for each condition to estimate oxygen metabolism. We will also analyze the relationship between these parameters and disease severity. While previous measurements were limited to the large retinal vessels, the ability to now measure oxygen saturation in the retinal tissue itself allows us to elucidate in greater detail the impact of these conditions on retinal tissue oxygenation. Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - For patients diagnosed with choroidal diseases, the study details and participation requirements were explained using an informed consent form during the examination. For patients who provided consent, retinal tissue oxygen saturation was measured continuously three times in both the affected eye and the contralateral eye using Zilia. This was performed in the same manner as standard fundus photography.

Eligibility: Age-lower limit - 20 years-old < Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Age: 20 years or older 2) Gender: Any 3) Retinal and choroidal diseases: Patients diagnosed with retinal and choroidal diseases based on examinations such as fundus examination, fluorescein angiography (FA), indocyanine green angiography (ICGA), or optical coherence tomography (OCT). 4) Patient Consent: Patients who, after receiving a thorough explanation regarding participation in this study and fully understanding it, provided written informed consent of their own free will. 5) Outpatients Key exclusion criteria - 1) Cases with severe corneal opacity, cataracts, or opacity of the intermediate transparent media 2) Cases in which both eyes are affected Target Size - 420

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 07 Day Date of IRB - 2025 Year 11 Month 28 Day Anticipated trial start date - 2025 Year 11 Month 28 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071090

Disclaimer: Curated by HT Syndication.