Clinical Validation Plan of Capsular Tension Ring

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2015
Through follow-up for 1 year or more, the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd. were verified, which is used for intraocular lens implantation in aphakic eyes after lens extraction to maintain capsular integrity, prevent posterior capsular wrinkle and resist capsular shrinkage. The clinical validation plan will be implemented after being approved by the Ethics Committee; the trial data of all cases before the 6-month visit period will be counted, and the statistical report, summary report and sub-center summary will be issued. The summary report and sub-center summary will be submitted to the CFDA for product registration.
Epistemonikos ID: 06d990a19d80749d2316d7ec0611bde9fdee505e
First added on: May 08, 2024