Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens

Observational, Non-controlled, Prospective Clinical Investigation to Evaluate Long-term Safety and Performance of Mini 4 Ready Intraocular Lenses in Cataract Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: monofocal intraocular lens

Detailed Description

This is an observational, non-controlled, prospective clinical investigation to evaluate long-term safety and performance of Mini 4 Ready Intraocular Lenses in cataract patients.

Specifically the aim of the investigation is to evaluate:

• 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;
• Evaluation of contrast sensitivity (CS) after 1 month following IOL implant.
• Incidence and severity of posterior capsule opacification (PCO) and incidence of posterior capsulotomy after 1 and 2 years following IOL eye implant.
• Monocular and binocular uncorrected (UDVA) and corrected (CDVA)distance VA at 4 m under photopic conditions at 1 and 6 months.
• Overall refractive power, measured as manifest (subjective) and subjective refraction, standard and converted to spherical equivalent refraction at 1 and 6 months and at 1 and 2 years.
• Defocus curve of the implanted eye under photopic conditions at 1 month.
• Occurrence of surgical reinterventions for whichever reason.
• Occurrence of any adverse untoward outcome, including any adverse event (such as, but not limited to, pseudophakic cystoid macular edema (PCME), retinal detachment, signs of inflammation, surgical site infections (SSI), pupillary block, and IOL tilt and decentration).
• Accumulated incidence of surgical reinterventions and of achievement of visual acuity (VA) of 0.3 logMAR units or better after 1- and 6-months following index eye implant.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95025
    • Daniela Nicolosi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

Subjects will be deemed eligible for the study if all of the following inclusion criteria are met:

1. Older than eighteen years of age at the time of surgery and diagnosed with cataract;
2. Unilateral or bilateral cataract removal by phacoemulsification;
3. Correction of resulting aphakia with the Mini 4 Ready IOL. Indication for use of the Mini 4 Ready should be previous to and not conditioned by study participation.
4. In case of bilateral cataract, subject able to underwent second cataract surgery within 1 months from first implant and not before 7 days;
5. Willing and able to complete all required postoperative visits;
6. Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.

Exclusion Criteria:

• Subjects participating in a concurrent clinical trial or who have participated in an ophthalmological clinical trial within the last 30 days.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
contrast sensitivity	Evaluation of contrast sensitivity (CS)	1 month post implant
posterior capsule opacification (PCO)	Incidence and severity of posterior capsule opacification (PCO)	1 and 2 years post implant
posterior capsulotomy	Incidence and severity of posterior capsulotomy	1 and 2 years post implant
Monocular and binocular uncorrected (UDVA)	Monocular and binocular uncorrected (UDVA) VA at 4 m under photopic conditions	1 and 6 months post implant
Monocular and binocular corrected distance VA (CDVA)	Monocular and binocular corrected distance VA (CDVA) at 4 m under photopic conditions	1 and 6 months post implant
manifest refraction	Overall refractive power, measured as manifest objective and subjective refraction, standard and converted to spherical equivalent refraction	1 month, 6 months, 1 year and 2 years
defocus curve	Defocus curve of the implanted eye under photopic conditions	1 month
surgical reinterventions	Occurrence of surgical reinterventions for whichever reasons	6 months
adverse events	Occurrence of any adverse untoward outcome, including any adverse event (such as, but not limited to, pseudophakic cystoid macular edema (PCME), retinal detachment, signs of inflammation, surgical site infections (SSI), pupillary block, and IOL tilt and decentration).	6 months
surgical reinterventions and visual acuity (VA) 1 - 6 months	Short-time accumulated incidence of surgical reinterventions and of achievement of visual acuity (VA) of 0.3 logMAR units or better	1 and 6 months

Collaborators and Investigators

• Sponsor: SIFI SpA

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Monofocal IOL; Monofocal intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 054/SI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No