Multifunctional Cataract Surgery Assistive Instruments Used in Cataract Surgery

NCT06182605 | Recruiting

• 1 other identifier: 2023-0370
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Successful implantation rate of intraocular lens

  implantation rate of intraocular lens with different instrument

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Visual function

  1day postoperation，1 week，1 month， 3month postoperation

• intraocular pressure

  1 day, 1 week, 1 month, and 3 month postoperation

Study Arms (2)

Multi-functional instruments

EXPERIMENTAL

Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor

Device: multifunctional instruments

Traditional instruments

ACTIVE COMPARATOR

Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor

Device: traditional instruments

Interventions

multifunctional instruments DEVICE

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,

Also known as: A set of available instruments including ophthalmic retractor, ophthalmic hook and membranous cataract scissors,

Multi-functional instruments

traditional instruments DEVICE

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.

Also known as: commonly used instruments for cataract surgery

Traditional instruments

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of cataract Patients need to undergo cataract surgery

You may not qualify if:

• \- 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

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

xu wen, PHD

CONTACT

13858185223; xuwen2003@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 27, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)