Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060228) titled 'The National Registry of Corneal Endothelial Damage after Glaucoma Surgery in Japan' on Feb. 1.
Study Type:
Observational
Primary Sponsor:
Institute - National Center for Geriatrics and Gerontology
Condition:
Condition - Glaucoma
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In recent years, the range of glaucoma surgical procedures has expanded, enabling stage-specific treatment selection. However, in some cases, irreversible complications such as corneal endothelial cell damage can occur after glaucoma surgery, which remains a major challenge in glaucoma management. This study aims to generate foundational data to support the development of future guidance on indications, postoperative care, and prevention of endothelial damage in glaucoma surgery by investigating the real-world burden and incidence of postoperative corneal endothelial cell damage and by establishing effective treatment strategies.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who underwent glaucoma surgery combined with cataract extraction at the participating institutions during the study period, including drainage device implantation, trabeculotomy, trabeculectomy, PreserFlo MicroShunt implantation, Ex-PRESS shunt implantation, and other glaucoma device implantation procedures.
Key exclusion criteria - Patients lacking preoperative corneal endothelial cell evaluation, as well as those judged unsuitable for inclusion by the principal investigator or sub-investigators at each participating center.
Target Size - 3000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 01 Day
Anticipated trial start date - 2026 Year 02 Month 01 Day
Last follow-up date - 2030 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068887
Disclaimer: Curated by HT Syndication.