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Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens
Sponsor: SIFI SpA
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.
Official title: Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
125
Start Date
2024-01-08
Completion Date
2027-07
Last Updated
2025-07-23
Healthy Volunteers
No
Conditions
Interventions
monofocal intraocular lens
monofocal aspheric hydrophilic-hydrophobic intraocular lens
Locations (1)
Daniela Nicolosi
Catania, Italy