Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- distant corrected near visual acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
outcome assessor will be masked to the intraocular lens implanted.
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
distant corrected near visual acuity
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Christina Leydolt
Assoc. Prof. PD Dr
Medical University of Vienna