Multifunctional Cataract Surgery Assistive Instruments Used in Cataract Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: multifunctional instruments, traditional instruments.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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 thr - 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.
Primary outcome measures
- Successful implantation rate of intraocular lens [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
- Visual function [Time frame: 1day postoperation，1 week，1 month， 3month postoperation]
- intraocular pressure [Time frame: 1 day, 1 week, 1 month, and 3 month postoperation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT06182605 · 2023-0370