Clinical Trial

Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens

Active, Not Recruiting
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Summary
Cataract surgery presents an extremely high success rate in improving vision and quality of life and it is currently the most commonly performed ophthalmic surgery, especially considering its growing utility in the aging population (e.g., more than 20 million worldwide underwent the procedure in 2015); it is possible to affirm that benefits clearly outweigh risks. However, although cataract surgery is highly effective and relatively safe, owing to the enormous numbers, even uncommon surgical complications could potentially harm the patients. For this reason, it is essential to continue to consider the possible risks and undesirable side-effects associated to cataract surgery, such as post-cataract endophthalmitis (POE), postcataract opacification (PCO), PCME, dysphotopsias, retinal detachment, and IOL dislocation.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-10-20; most recent amendment 2025-07-18.
Status change: Recruiting → Active, Not Recruiting 2025-07-18
Status change: Not Yet Recruiting → Recruiting 2024-02-01
Trial Details
NCT Number NCT06093880
Lead Sponsor SIFI SpA
Conditions Cataract
Enrollment 125 participants
Start Date 2024-01-08
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-07-23