A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism

Inclusion criteria

• adult patients (18 years old and older);
• cataract and/or corneal astigmatism diagnosis;
• indication for cataract surgery or refractive lens exchange;
• recommended cylinder correction with toric IOL with cylinder power ≥1.0D;
• clear intraocular media other than cataract;
• signed informed consent form;

Exclusion criteria

• irregular astigmatism;
• patients who are not targeted to emmetropia (predicted residual spherical equivalent and/or astigmatism is out of the range of ±0.5D and ±0.38D respectively);
• any retinopathy or maculopathy that affects the vision;
• iris neovascularization;
• congenital eye abnormality affecting visual performance;
• advanced glaucoma;
• pseudoexfoliation syndrome affecting IOL stability;
• amblyopia;
• uveitis;
• retinal detachment;
• prior ocular surgery in personal medical history;
• irregular corneal curvature or corneal diseases affecting visual performance;
• high myopia (axial length ≥ 26,5 mm);
• inadequate visualization of the fundus on preoperative examination;
• dilated pupil size not large enough to visualize toric IOL axis markings postoperatively based on the Investigator's decision;
• eye trauma in medical history;
• instability of keratometry or biometry measurements;
• prior corneal refractive surgery such as LASIK, PRK, or SMILE;
• patients deemed ineligible by the investigator because of any systemic disease or treatment;
• pregnancy or lactation;
• current use of systemic steroids or external ophthalmic drugs;
• concurrent participation in another drug or device investigation.

Intraoperative exclusions: the presence of the following intraoperative exclusion criteria will lead to the exclusion of the subject:

• Any unexpected or serious intraoperative complication that makes IOL implantation impossible or results in implantation of another type of IOL that is outside the scope of this clinical trial.