Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-04 @ 5:42 PM
Study NCT ID:
NCT06182605
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2023-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multifunctional Cataract Surgery Assistive Instruments Used in Cataract Surgery
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Multifunctional Cataract Surgery Assistive Instruments Used in Cataract Surgery
Status:
RECRUITING
Status Verified Date:
2025-04
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:
None
Brief Summary:
In order to better cope with complex situations of cataract surgery, we designed and improved a new set of multi-functional cataract surgery auxiliary devices, including ophthalmic surgery auxiliary hooks, eye retractor hooks and membranous cataract scissors. Their common feature is that they have the function of 2-3 traditional surgical instruments, which can be switched in operations, reducing the replacement of different surgical instruments, lowing the number of surgical instruments in and out of the incision, reducing trauma and improving surgical efficiency. The purpose of this multi-center prospective clinical study is to verify the advantages of this new group of multifunctional devices and further summarize the experience and improvement by comparing the safety and effectiveness of traditional cataract surgical instruments combined with new multifunctional cataract assisted surgical instruments and traditional cataract surgical instruments alone.
Detailed Description:
Cataract is the number one cause of blindness, and the main treatment method is surgery to remove the cloudy lens and install an intraocular lens. The operation relies on ophthalmic micromanipulative instruments, but in complex cases such as abnormal lens capsule, ocular trauma, etc., the difficulty of surgery increases, so that conventional instruments are often unable to complete the operation well. In order to better cope with these complex situations, we designed and improved a new set of multi-functional cataract surgery auxiliary devices, including ophthalmic surgery auxiliary hooks, eye retractor hooks and membranous cataract scissors, which have obtained utility model patents and first-class medical device filings. Their common feature is that they have the function of 2-3 traditional surgical instruments, which can be switched intraoperatively, reduce the replacement of different surgical instruments, reduce the number of surgical instruments in and out of the incision, reduce trauma and improve surgical efficiency. The purpose of this multi-center prospective clinical study is to verify the advantages of this new group of multifunctional devices and further summarize the experience and improvement by comparing the safety and effectiveness of traditional cataract surgical instruments combined with new multifunctional cataract assisted surgical instruments and traditional cataract surgical instruments alone.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: