Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

SIFI

Status: Completed

Conditions: Cataract; Astigmatism

Treatments: Device: Mini Toric IOL

Study type: Observational

Funder types: Industry

Identifiers

NCT06250855

055/SI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.