Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients
Sponsor study identifier
observational
125
1 country
1
Study Start
January 8, 2024
Actual (reported)Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2023
Actual (reported)October 23, 2023
Actual (reported)January 8, 2024
Actual (reported)July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
surgical reinterventions and visual acuity (VA) 1-2 years
Long-time accumulated incidence of surgical reinterventions and of achievement of visual acuity (VA) of 0.3 logMAR units or better after 1 and 2 years following IOL implant.
1 - 2 years post implant
contrast sensitivity
1 month post implant
posterior capsule opacification (PCO)
1 and 2 years post implant
posterior capsulotomy
1 and 2 years post implant
Monocular and binocular uncorrected (UDVA)
1 and 6 months post implant
Monocular and binocular corrected distance VA (CDVA)
1 and 6 months post implant
monofocal aspheric hydrophilic-hydrophobic intraocular lens
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The target population comprise men and women aged ≥18 years requiring unilateral or bilateral cataract surgery and who are eligible for a monofocal IOL. The source population comprise patients scheduled to receive the Mini 4 Ready IOL in whom the cataractous lens could be removed by phacoemulsification following circular capsulorhexis, leaving the posterior capsule intact.
Daniela Nicolosi
Catania, 95025, Italy
First Submitted
October 11, 2023
First Posted
October 23, 2023
Study Start
January 8, 2024
Actual (reported)Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Assesment of Intermediate Vision After BIL Cataract Surgery
Contact the study team to confirm eligibility.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 23, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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