Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 461
- Locations
- 1
- Primary Endpoint
- Distant corrected intermediate 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
- Non 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 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Distant corrected intermediate visual acuity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Distant corrected intermediate visual acuity
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Contrast sensitivity and reading ability(2-6 months and 1-5 years)
Investigators
Christina Leydolt
Assoc. Prof. PD Dr
Medical University of Vienna