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

Launched by MEDICONTUR MEDICAL ENGINEERING LTD · Aug 28, 2024

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Gender

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Eligibility criteria

• 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.