H26.9
Conditions
Interventions
Group 1: Intervention arm (implantation of a multifocal intraocular lens during a cataract surgery)
Sponsors
Universitätsmedizin Rostock, Klinik und Poliklinik für Augenheilkunde
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: • The patient must be at least 45 years old • Presbyopia • Cataract • The patient wants to be independent of glasses for near and distance vision • The patient's lifestyle and expectations match multifocal IOL implantation • Suitable for bilateral implantation where a toric IOL must be implanted in at least one eye • The IOL power calculated for the patient must be within the available diopter range • Expected best corrected visual acuity after IOL implantation is 20/25 or better • No secondary surgery planned during the course of the study • Availability, willingness and sufficient cognitive awareness and physical ability to complete the examination procedures throughout the study period • Patients must provide written informed consent
Exclusion criteria
Exclusion criteria: • Preoperative corneal astigmatism less than 1.00 D in both eyes • Patients who do not give informed consent • Patients who do not understand the process of the study • Previous corneal surgery or trauma. • Irregular cornea (e.g. keratoconus) • Choroidal hemorrhage • Microphthalmos • Severe corneal dystrophy • Glaucoma in the medically controlled or medically controlled • Clinically significant macular changes • Serious eye disease as a side effect • Non-age related cataract • Severe atrophy of the optic nerve • Diabetic retinopathy • Proliferative diabetic retinopathy • Amblyopia • Extremely shallow anterior chamber • Severe chronic uveitis • Pregnant or breastfeeding women • Rubella • Mature/dense cataract complicating preoperative fundus examination • Previous retinal detachment • Concurrent participation in other drug or clinical device research • Need for further eye surgery during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main hypothesis is to investigate the rotational stability up to 3 months after implantation of the Asqelio™™ Trifocal IOL in cataract surgery and to evaluate the refractive results after implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of the Asqelio™ Trifocal Toric 3 months post-implantation | — |
Countries
Germany
Contacts
Public ContactTobias Brockmann
Universitätsmedizin Rostock, Klinik und Poliklinik für Augenheilkunde
Outcome results
None listed