New method for cataract surgery using microinterventional technology
Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery Versus Conventional Phacoemulsification Using Divide-and-conquer: a Randomized Controlled Trial
This study is testing a new cataract surgery method using a special tool to see if it can help patients with advanced cataracts recover better than traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oogziekenhuis Rotterdam Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05736042 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of miLOOP-assisted cataract surgery compared to conventional methods. The focus is on patients with advanced nuclear cataracts, specifically those with a LOCS III grade of 5 or higher. The study will measure the cumulative dispersed ultrasound energy used during surgery and the resulting loss of corneal endothelial cells. By utilizing microinterventional techniques, the trial seeks to reduce the energy required for phacoemulsification, potentially leading to better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with advanced visually significant nuclear cataracts graded at LOCS III grade 5 or more.
Not a fit: Patients with low endothelial cell density, corneal opacification, or a history of certain eye surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could minimize corneal endothelial cell loss during cataract surgery, improving recovery and long-term vision outcomes for patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in reducing energy use during cataract surgery, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Informed consent. * Advanced visually significant nuclear sclerosis grade ≥ 5 (LOCS III). Exclusion Criteria: * Endothelial cell density (ECD) \< 1500 mm-2. * Corneal opacification (any cause). * Corneal surgery or trauma. * Implant lens. * Refraction surgery. * Prior glaucoma surgery. * Pseudoexfoliation.
Where this trial is running
Rotterdam
- Oogziekenhuis Rotterdam — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Rene Wubbels
- Email: r.wubbels@oogziekenhuis.nl
- Phone: +31104023430
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.