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NCT Number: NCT06182605

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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,

Other names: A set of available instruments including ophthalmic retractor, ophthalmic hook and membranous cataract scissors,

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.

Other names: commonly used instruments for cataract surgery

Primary outcomes

  1. Successful implantation rate of intraocular lens

    Time frame: through study completion, an average of 1 year

    implantation rate of intraocular lens with different instrument

Secondary outcomes

  1. Visual function

    Time frame: 1day postoperation,1 week,1 month, 3month postoperation

    Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart

  2. intraocular pressure

    Time frame: 1 day, 1 week, 1 month, and 3 month postoperation

    intraocular pressure

Study contacts

Contact information is provided by the study sponsor or research team.

xu wen, PHD

CONTACT

[email protected]

13858185223

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 27, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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