Observational, Prospective Clinical Investigation on Mini 4 Ready Intraocular Lens

NCT06093880 | Active Not Recruiting

• 1 other identifier: 054/SI
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Monofocal IOL; Monofocal intraocular lens

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Interventions

monofocal intraocular lens DEVICE

monofocal aspheric hydrophilic-hydrophobic intraocular lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Older than eighteen years of age at the time of surgery and diagnosed with cataract;
• Unilateral or bilateral cataract removal by phacoemulsification;
• 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.
• In case of bilateral cataract, subject able to underwent second cataract surgery within 1 months from first implant and not before 7 days;
• Willing and able to complete all required postoperative visits;
• Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.

You may not qualify if:

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

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (1)

Daniela Nicolosi

Catania, 95025, Italy

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 23, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

IT (1)