Evaluation of Mini 4 Ready Intraocular Lens in cataract patients
Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients
This study is testing how safe and effective the Mini 4 Ready Intraocular Lens is for people getting cataract surgery by looking at their vision and any complications over one to two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SIFI SpA Industry-sponsored |
| Locations | 1 site (Catania) |
| Trial ID | NCT06093880 on ClinicalTrials.gov |
What this trial studies
This observational investigation aims to assess the long-term safety and performance of the Mini 4 Ready Intraocular Lens (IOL) in patients undergoing cataract surgery. The study will track various outcomes, including visual acuity, contrast sensitivity, and the incidence of complications such as posterior capsule opacification over a period of one to two years. Participants will be monitored for surgical reinterventions and any adverse events following the IOL implantation. The study focuses on both monocular and binocular visual outcomes to provide a comprehensive evaluation of the lens's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with unilateral or bilateral cataracts who are undergoing phacoemulsification surgery.
Not a fit: Patients currently participating in another clinical trial or those who have been involved in an ophthalmological trial within the last 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the Mini 4 Ready IOL's safety and effectiveness, potentially leading to improved patient outcomes in cataract surgery.
How similar studies have performed: While cataract surgery is well-established, this specific investigation into the Mini 4 Ready IOL's long-term outcomes is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects will be deemed eligible for the study if all of the following inclusion criteria are met: 1. Older than eighteen years of age at the time of surgery and diagnosed with cataract; 2. Unilateral or bilateral cataract removal by phacoemulsification; 3. Correction of resulting aphakia with the Mini 4 Ready IOL. Indication for use of the Mini 4 Ready should be previous to and not conditioned by study participation. 4. In case of bilateral cataract, subject able to underwent second cataract surgery within 1 months from first implant and not before 7 days; 5. Willing and able to complete all required postoperative visits; 6. Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects. Exclusion Criteria: * Subjects participating in a concurrent clinical trial or who have participated in an ophthalmological clinical trial within the last 30 days.
Where this trial is running
Catania
- Daniela Nicolosi — Catania, Italy (Recruiting)
Study contacts
- Study coordinator: Daniela Nicolosi
- Email: daniela.nicolosi@sifigroup.com
- Phone: 095792218
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.