Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens
NCT06093880 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 125
Last updated 2025-07-23
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.
Conditions
- Cataract
Interventions
- DEVICE
-
monofocal intraocular lens
monofocal aspheric hydrophilic-hydrophobic intraocular lens
Sponsors & Collaborators
-
SIFI SpA
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-08
- Primary Completion
- 2027-07-31
- Completion
- 2027-07-31
Countries
- Italy
Study Locations
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