Tokyo, Nov. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059646) titled 'The usefulness of the UNITY VCS Tetra-Spot Laser Probe in panretinal photocoagulation (PRP)' on Nov. 5.

Study Type: Observational

Primary Sponsor: Institute - Kyorin University Hospital

Condition: Condition - Patients with proliferative diabetic retinopathy requiring panretinal photocoagulation (PRP) treatment Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare and evaluate the surgical efficiency and postoperative outcomes of vitreoretinal surgery using the UNITY VCS Tetra-spot laser and the CONSTELLATION single-spot laser in patients with proliferative diabetic retinopathy (PDR) requiring panretinal photocoagulation (PRP). Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients scheduled to undergo vitreous surgery for proliferative diabetic retinopathy during the study period, who have not received PRP or require additional PRP. 2. Patients expected to receive 2,000 to 4,000 laser shots during PRP. 3. Patients scheduled to undergo PRP from the vascular arcade to the peripheral retina (near the ora serrata). 4. Patients aged 20 years or older at the time of consent. 5. Patients who have provided written informed consent of their own free will to participate in this study. Key exclusion criteria - 1. Patients with retinal diseases other than diabetic retinopathy, such as retinal vein occlusion or uveitis 2. Patients with neovascular glaucoma 3. Patients using steroids or other anti-inflammatory drugs 4. Patients whose random blood glucose level is 350 mg/dL or higher, or whose HbA1c is greater than 10.0. 5. Patients with systemic complications that make imaging difficult 6. Patients deemed inappropriate for inclusion by the investigator 7. Patients who have expressed unwillingness to participate in this study, or whose legally authorized representatives have expressed such unwillingness Target Size - 32

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 17 Day Date of IRB - 2025 Year 10 Month 17 Day Anticipated trial start date - 2025 Year 11 Month 05 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068227

Disclaimer: Curated by HT Syndication.