Multifunctional Cataract Surgery Assistive Instruments Used in Cataract Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: multifunctional instruments; Device: traditional instruments

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xu wen, PHD; Phone Number: 13858185223; Email: xuwen2003@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: wen xu; Phone Number: 13858185223; Email: xuwen2003@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Clinical diagnosis of cataract Patients need to undergo cataract surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-functional instruments; Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor	Device: multifunctional instruments; Ophthalmic retractors can be used to lift the lens during surgery to assist in lens sucking or resection; Intraoperative injection of reagent, which has the advantage of retractable, micro-incision. Ophthalmic hooks can be used to secure support capsular bags; auxiliary cleavage; polishing capsule; Viscoelastic agent is injected as needed. The front end of the membranous cataract scissor is a capsular tearing forceps, and the capsule tearing and capsule scissors can be flexibly switched. All three instruments have the functions of two or three traditional instruments, which can be designed to reduce the number of times the instruments enter and exit the incision during surgery, improve surgical efficiency,; Other Names: A set of available instruments including ophthalmic retractor, ophthalmic hook and membranous cataract scissors,
Active Comparator: Traditional instruments; Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor	Device: traditional instruments; traditional Cataract-assisted instruments for cataract operation.Puncture knives, microscissors, microscopic forceps, nucleus hooks, lens graft forceps, are used to cut the cornea, assist in removing the cloudy lens, suturing wounds.; Other Names: commonly used instruments for cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful implantation rate of intraocular lens	implantation rate of intraocular lens with different instrument	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual function	Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart	1day postoperation，1 week，1 month， 3month postoperation
intraocular pressure	intraocular pressure	1 day, 1 week, 1 month, and 3 month postoperation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 24, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2023-0370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No