H25-H28
Conditions
Interventions
Group 1: The present clinical observational study aims to systematically collect clinical data on the performance of the two intraocular lenses, TrivaT-aAY and Triva-aAY IOL, when used according to th
Sponsors
HumanOptics Holding AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Adult male or female patients with uncomplicated bilateral senile cataract, with both eyes treated within a short interval - Availability, willingness, and adequate cognitive capacity to participate in follow-up visits - Signed informed consent - Functional pupillary adaptation - Target refraction: emmetropia - Preoperative corneal astigmatism = 0.75 diopters (D) in at least one eye
Exclusion criteria
Exclusion criteria: - Previous corneal or intraocular surgery - Corneal spherical aberration (sA) > 0.4 µm - Untreated, uncontrolled glaucoma - Dementia - Ocular comorbidities affecting visual acuity (maculopathy, age-related macular degeneration, corneal opacities, glaucoma, retinal detachment, prior vitrectomy, trauma, uveitis, iris atrophy) - Rigid pupil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Uncorrected and distance-corrected visual acuity for distance (6 m), intermediate (60 cm), and near (40 cm) - Subjective refraction | — |
Secondary
| Measure | Time frame |
|---|---|
| - Contrast sensitivity under photopic and mesopic conditions (binocular) - Patient questionnaire including spectacle independence - Halo & glare simulator (binocular) - Defocus curve - Rotational stability | — |
Countries
Germany
Contacts
Public ContactTimo Abbe
HumanOptics Holding AG
Outcome results
None listed