H25.9
Conditions
Interventions
Group 1: Clareon PanOptix intraocular lens (IOL)
Group 2: AT ELANA intraocular lens (IOL)
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Availability, willingness, and enough cognitive awareness to comply with examination procedures. 2. Bilateral age-related cataract 3. Patients suitable for bilateral implantation with either one of the trifocal IOLs with femtosecond laser assisted cataract surgery 4. Legally capabable to give informed consent and personally signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Age of patient 0.75 D via IOL Master 700 4. HOA measured by Pentacam exceeding 0.3 microns in standard display with 4mm pupil. 5. Difficulty for cooperation (distance from their home, general health condition) 6. Clinically significant glaucoma (subjects with repeat glaucomatous structural or functional pattern loss noted on VF or OCT) as well as subjects with IOP >21mmHg measured during screening visit or the current use of any glaucoma medications. 7. Macular degeneration, macular edema, or proliferative diabetic retinopathy 8. Patients with corneal dystrophies 9. Any ocular comorbidity having a significant effect on the postoperative clinical outcomes 10. History of ocular trauma or prior ocular surgery including refractive procedures 11. Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, Marfan’s syndrome) 12. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 60 cm (logMAR) at 3 months postoperative using ETDRS charts | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients that answer “Not at all” for halos on the McAlinden bothersome dysphotopsia questionnaire after 3 months. Further secondary endpoints: • Outcome of Glare and Starburst Questionnaire (McAlinden) at 3 months. • Outcomes of Halo and Glare Simulator (Eyeland-Design Network GmbH, Vreden, Germany) after 3 months • Monocular and binocular UDVA and CDVA at 4 m, UIVA and DCIVA at 80cm and 60 cm after 3 months. • Monocular and binocular UNVA and DCNVA at 33 and 40 cm after 3 months • Defocus Curve (Distance Corrected, photopic, binocular, +2.0 to -3.0 D) after 3 months. • Manifested refraction (sphere, cylinder and MRSE): after 3 months, • Outcomes measures of questionnaire (IOLSat) after 3 months | — |
Countries
Austria, Germany
Contacts
Public ContactRamin Khoramnia
Medizinische Fakultät Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
Outcome results
None listed