Cataract
Conditions
Brief summary
prospective, comparative (3 arms), randomized, multicentric clinical trial
Interventions
DEVICEEDoF1
extended depth of focus IOL - EDoF1
DEVICEMonofocal
Monofocal IOL
DEVICEEDoF2
Comparison EDoF2 IOL
Sponsors
Carl Zeiss Meditec AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent; * Patients of any gender, aged 50 to 80 years; * Assured follow-up examinations; * clinically significant bilateral cataract;
Exclusion criteria
* Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial; * Patients whose freedom is impaired by administrative or legal order; * Current participation in another drug or device investigation; * Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye * Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.) * Pseudoexfoliations syndrome * Pathologic miosis or Pharmacotherapy with miotic agent * Keratoconus * Chronic or recurrent uveitis * Diabetic retinopathy * Uncontrolled glaucoma and or IOP\>24mmHg * Choroidal hemorrhage, * All kind of infections (acute ocular disease, external/internal infection, systemic infection) * Traumatic cataract * Aniridia * Microphthalmia * Amblyopia * Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders) * Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up * Previous intraocular and corneal surgery * Expected postop. astigmatism greater than 1 D * Any type of corneal disorder * Systemic or ocular pharmacotherapy, which can impact the visual acuity, * Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion * Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus) * Dementia * pregnancy or lactation period for female patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defocus curve measurement | 1 month |
Countries
Germany
Outcome results
None listed