Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04880018
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2021-04-29
Brief Title:
Clinical Validation Plan of Capsular Tension Ring
Sponsor:
Eyebright Medical Technology Beijing Co Ltd
Organization:
Eyebright Medical Technology Beijing Co Ltd
Study Overview
Official Title:
Clinical Validation Plan of Capsular Tension Ring
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVPOCTR
Brief Summary:
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
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
Detailed Description:
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 2040 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 12 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
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 2040 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 12 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015QXNL002 | OTHER | Zhongshan Ophthalmic Center Sun Yat-sen University | None |