New multifunctional instruments for cataract surgery
Multifunctional Cataract Surgery Assistive Instruments Used in Cataract Surgery
This study is testing new surgical tools for cataract surgery to see if they make the procedure easier and safer compared to the traditional tools.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06182605 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a new set of multifunctional instruments designed to assist in cataract surgery, particularly in complex cases. The instruments combine the functions of 2-3 traditional surgical tools, allowing for easier switching during operations, which aims to reduce trauma and improve surgical efficiency. The study will compare the safety and effectiveness of these new instruments against traditional cataract surgical instruments in a multi-center prospective setting. The goal is to verify the advantages of these multifunctional devices in real surgical scenarios.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with cataracts who require surgical intervention.
Not a fit: Patients with active intraocular inflammation, high intraocular pressure, low endothelial cell count, or other serious eye or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to safer and more efficient cataract surgeries with reduced trauma for patients.
How similar studies have performed: While similar approaches have been explored, this specific combination of multifunctional instruments is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: xu wen, PHD
- Email: xuwen2003@zju.edu.cn
- Phone: 13858185223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.