Clinical Validation Plan of Capsular Tension Ring

Overview

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.

According to the principle of "Quality management standard for clinical trials of medical devices" issued by CFDA, a multi-center, randomized, open, positive product, parallel controlled trial design was adopted to evaluate the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd. Considering the progress of clinical verification and the reliability of the conclusion, the multi-center trial design was adopted in this clinical verification. Multi-center clinical trials can collect more cases in a short time, and cover a wide population of cases, which avoids the limitations of a single research, and the conclusions can have a wider significance and greater credibility. In order to demonstrate the effectiveness and safety of the product, and to verify whether the product has the same efficacy and safety as the marketed product, a positive product and a parallel controlled trial design were selected for the validation; The "Capsular Tension Ring" produced by Carl Zeiss, with the same material, structure, design, implantation mode and location, and indications, was selected as the positive parallel control product, and the clinical trial was conducted simultaneously with the validation product. In view of the fact that this clinical trial is a comparative research of positive products and parallel controls, in order to ensure the comparability of cases in each group, avoid bias caused by various factors in the design, execution, and analysis of the clinical trial. This clinical verification adopts a randomization method and uses a central random system to achieve dynamic randomization to ensure that cases are evenly allocated to the test group or the control group. Due to the variety of product specifications in this clinical verification, the use of the verification product and the reference substance is slightly different. This verification cannot be double-blind, so an open clinical trial design is adopted. Based on the above considerations and adhering to the scientific principle, in order to verify the safety and effectiveness of the Capsular Tension Ring produced by Eyebright, a multi-center, randomized, open, positive product, parallel controlled trial method was adopted in this clinical verification. At the same time, 120 cases of cataract patients were selected according to the statistical requirements. After screening and examination, those who met the inclusion criteria were selected for validation. Surgical treatment and implantation of validation or control products were performed. Clinical follow-up evaluation was planned at 1-2 days, 1 week, 1 month, 3 months, 6 months and 1 year after operation. The percentage of patients whose best corrected visual acuity reached 20/40 at 6 months after operation was taken as the main efficacy indicator; At the same time, observe the visual acuity, optometry results, intraocular pressure, lens eccentricity, capsule shrinkage, etc. after 1\~2 days, 1 week, 1 month, 3 months, 6 months and 1 year or more after operation; The main safety indicators are the incidence of complications, adverse events and serious adverse events during the observation period, and adverse events and serious adverse events related to the validated device.