Age-related Cataract
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
intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification
Sponsors
Medical University of Vienna
Study design
Allocation
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 two groups recieving predefined EDOF and multifocal intraocular lenses. In group one (I), the EDOF lens one (I) will be implanted in the dominant eye and the multifocal lens one (I) in the non-dominant eye. Subsequently, study participants in group two (II) will receive the EDOF lens one (I) in the dominant eye and the multifocal lens two (II) in the non-dominant eye.
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned * Age 50-90 * Visual potential in both eyes of 20/30 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
Exclusion criteria
* Preceding ocular surgery or trauma * Relevant other ophthalmic diseases (such as retinal degenerations, etc.) * Uncontrolled systemic or ocular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| distant corrected near visual acuity | 6 months | Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Binocular Uncorrected Near Visual Acuity | 3 years | Other outcome measure will be binocular uncorrected near visual acuity (UNVA) of each mix-and-match group. Binocular UNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale. |
Countries
Austria
Outcome results
None listed