Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

Completed

• Conditions: Cataract; Astigmatism

• Registration Number: NCT06250855
• Lead Sponsor: SIFI SpA

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.

Detailed Description

Observational prospective clinical investigation based on the medical records of patients who undergone uncomplicated cataract surgery with implantation of Mini Toric Ready IOL and on a clinical visit after at least one year from the surgery. Eyes with corneal astigmatism ≥0.75 diopters were included. Postoperative evaluations included monocular or binocular uncorrected and corrected distance visual acuity; contrast sensitivity measured after at least one-year postoperatively.

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Study Start: 2024-04-24
• Primary Completion: 2024-10-27
• Study Completion: 2024-10-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the Visual Performance	From 12 to 24 months post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Stability	From 12 to 24 months post-surgery	Intraocular Lens (IOL) Rotation Stability

Trial Locations

Locations (2)

Gauss Clinic Bacau; 🇷🇴 Bacau, Romania

Immunoeye SRL; 🇷🇴 Sfântu-Gheorghe, Romania