Postoperative Outcomes of a Toric AddOn Intraocular Lens After Keratoplasty and Cataract Surgery

The aim of this clinical study is to evaluate a toric add-on intraocular lens (IOL) for the correction of high astigmatism in patients who have undergone keratoplasty and cataract surgery. As this patient group often suffers from significant preoperative residual astigmatism, there is a relevant clinical need for effective and safe refractive treatment options. The implantation of a toric add-on IOL in the ciliary sulcus is intended to significantly reduce postoperative astigmatism and improve visual rehabilitation. The study is designed as a prospective, monocentric clinical trial with a limited number of cases, as this is a rare condition with limited availability of suitable patients. It is being conducted in accordance with Section 3 of the Austrian Medical Devices Act (MPG 2021) and is investigating a CE-marked add-on intraocular lens implant used within its intended purpose. The postoperative refractive cylinder serves as the primary endpoint, as it reflects the actual effectiveness of astigmatism correction. The rotational stability of the add-on IOL, which significantly influences refractive precision, is recorded as a secondary endpoint. All study participants will be examined pre- and postoperatively in accordance with applicable medical standards. The results should contribute to the optimization of refractive care after keratoplasty and assess the clinical applicability of toric AddOn IOLs in this specific indication.

Inclusion Criteria: * Gender: female, male, or diverse * Ophthalmological diagnosis: pseudophakic patients after keratoplasty * Age: 45 to 95 years * Complication-free cataract surgery using phacoemulsification and implantation of a posterior chamber lens. * Complication-free keratoplasty and regular postoperative corneal astigmatism \> 1 diopter (D) * Pupil diameter in mydriasis \> 5.5 mm Exclusion Criteria: * Uncontrolled glaucoma * Proliferative diabetic retinopathy * Iris neovascularization * History of uveitis or iritis * Microphthalmus * Recurrent intraocular inflammation of unknown cause * Blindness in the other eye * Uncontrolled systemic or ocular disease * Pregnancy * Breastfeeding