Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

NCT06250855 | Completed

• 1 other identifier: 055/SI
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluation, at least one-year long-term, of the clinical performance and safety of Mini Toric Ready Intraocular Lens (IOL), a monofocal toric intraocular lens.

Conditions

Cataract; Astigmatism

Keywords

Cataract; Astigmatism; Monofocal IOL; Toric IOL

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Visual Performance

  Evaluate Mini Toric Ready Intraocular Lens (IOL) performance in terms of correction of spherical and cylindrical visual defects, corrected and uncorrected monocular and/or binocular distance visual acuity at least 12 months post implant.

  From 12 to 24 months post-surgery

Secondary Outcomes (1)

• Evaluation of the Stability

  From 12 to 24 months post-surgery

Other Outcomes (2)

• Evaluation of the safety profile: Adverse Events (AEs)

  From 12 to 24 months post-surgery

• Evaluation of the safety profile

  From 12 to 24 months post-surgery

Interventions

Mini Toric IOL DEVICE

Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation after cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation. Subjects enrolled in the investigation underwent cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.

You may qualify if:

• Eighteen years of age or older at the time of surgery and diagnosed with unilateral or bilateral cataracts;
• Preoperative total corneal astigmatism ≥0.75D;
• Unilateral or bilateral cataract removal by phacoemulsification;
• Clear intraocular media other than cataract;
• 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 if they have participated in an ophthalmology clinical trial within the last 30 days before the surgery.

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (2)

Gauss Clinic Bacau

Bacau, 600269, Romania

Location

Immunoeye SRL

Sfântu Gheorghe, 520024, Romania

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

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

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: April 24, 2024
• Primary Completion: October 27, 2024
• Study Completion: October 27, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2)