Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06182605 |
Other study ID # |
2023-0370 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2024 |
Est. completion date |
June 30, 2025 |
Study information
Verified date |
November 2023 |
Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
Contact |
xu wen, PHD |
Phone |
13858185223 |
Email |
xuwen2003[@]zju.edu.cn |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.