NCT02990689CompletedNot Applicable
Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Carl Zeiss Meditec AG
- Enrollment
- 55
- Primary Endpoint
- Intermediate visual acuity
Study Overview
Brief Summary
The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients of any gender, aged 50 to 80 years
- •Signed informed consent form
- •Healthy eyes besides cataract
- •Assured follow-up examinations
- •Stable corneal conditions within the last 12 months
- •Corneal astigmatism less than 1D
- •Implantation into the capsular bag by injector
Exclusion Criteria
- •Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
- •Pseudophakia
- •Cornea guttata; keratoplasty
- •Irregular astigmatism (e.g. Keratoconus)
- •Corneal scarring
- •Diabetic retinopathy
- •Amblyopia
- •Amotio operation; anamnesis with vitreous surgery
- •Pseudoexfoliation Syndrome; Uveitis
- •Previous intraocular and corneal surgery
- •Intraocular tumours; endotamponade
- •Glaucoma or IOP higher than 24mmHg
- •Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
- •Need for a dioptre out of the range of +16.0D to +26.0D
- •Inability to achieve secure lens placement in the capsular bag
- •Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
- •Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
- •Pregnancy or lactation period for female patients
Arms & Interventions
809M
Active Comparator
bifocal intraocular lens (IOL)
Intervention: Bifocal Intraocular Lens (Device)
839MP
Active Comparator
trifocal intraocular lens (IOL)
Intervention: Trifocal Intraocular Lens (Device)
SN6AD1
Active Comparator
bifocal intraocular lens (IOL)
Intervention: Low Addition Bifocal Intraocular Lens (Device)
Outcomes
Primary Outcomes
Intermediate visual acuity
Time Frame: 12 months
Secondary Outcomes
- Distance visual acuity(12 months)
- Near visual acuity(12 months)
Investigators
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