Multifunctional Cataract Surgery Assistive Instruments Used in Cataract Surgery

Last updated: May 12, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disease

Eye Disorders/infections

Treatment

multifunctional instruments

traditional instruments

Clinical Study ID

NCT06182605
2023-0370
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of cataract Patients need to undergo cataract surgery

Exclusion

Exclusion Criteria:

  • Active intraocular inflammation The intraocular pressure (IOP) was higher than 25mmHg The endothelial cell count (ECC) was less than 1,200 cells/mm2 Combined withother eye diseases Combined with other serious systemic diseases

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: multifunctional instruments
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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