Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

At Least One-year Long-term Clinical Outcomes Following Monofocal Toric Intraocular Lens Implantation: Observational Prospective Clinical Investigation

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.

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.

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.