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ACTIVE NOT RECRUITING
NCT06093880

Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens

Sponsor: SIFI SpA

View on ClinicalTrials.gov

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

DEVICE

monofocal intraocular lens

monofocal aspheric hydrophilic-hydrophobic intraocular lens

Locations (1)

Daniela Nicolosi

Catania, Italy