Age Related Cataracts
Conditions
Brief summary
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.
Interventions
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
outcome assessor will be masked to the intraocular lens implanted
Intervention model description
Intra-individual comparison of 7 groups receiving predefined monofocal and enhanced monofocal intraocular lenses (EMO IOLs). Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the dominant eye and the other IOL type in the non- dominant eye.
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation * Age 50 to 100 * Visual potential in both eyes of 20/25 or better as determined by investigators estimation * Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL) * postoperativ binocular best corrected distance visual acuity (BCVA) ≥ 1.0 decimal (Arm ten (X)) * Standard cataract surgery with bilateral implantation of a monofocal IOL (Vivinex XC1 or Vivinex XY1) (Arm ten (X))
Exclusion criteria
* Preceding intraocular surgery or ocular trauma * Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma) * Pupil diameter \< 2.0 mm (photopic) * Laser treatment * Uncontrolled systemic or ocular disease * Pregnancy/Nursing * childbearing ability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant corrected intermediate visual acuity | 2-6 months | Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale. |
| Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL | 3-5 months | Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted in eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale. |
| Contrast sensitivity and reading ability - Vivinex XC1 and Vivinex XY1 | 2-6 months and 1-5 years | Primary outcome measures for arm ten (X) will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity and reading ability | 2-6 months and 1-5 years | Secondary outcome measures will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions. |
Countries
Austria
Contacts
Primary ContactChristina Leydolt, MD
Outcome results
None listed