To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses

Study Overview
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Brief Summary
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To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.

Official Title
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Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses

Conditions
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Cataract

Intervention / Treatment
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* Device: CZM IOL
* Device: Competitor IOL


Participation Criteria
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Eligibility Criteria
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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 18 or older Assured follow-up examinations Healthy eyes with clinically significant age related cataract requiring surgical treatment Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement) 8. Cataract density compatible with biometry measurement 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 that affects patients vision Ocular disorders, other than cataract, that could potentially cause future acuity loss Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm) Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.) Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.) History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis Pseudoexfoliation syndrome (according to investigator decision) Pathologic miosis or Pharmacotherapy with miotic agent Irregular astigmatism / Keratoconus Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment. All kind of infections (acute ocular disease, external / internal infection, systemic infection) Traumatic cataract Monophthalmic patient Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus Patient expected to require retinal laser treatment before the end of the last follow-up examination Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination Previous intraocular and corneal / refractive surgery Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision) Dementia Previous use of cytotoxic drugs or total body irradiation within last 2 years Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient Pregnancy and / or lactation period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: comparative randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CZM IOL<br> | Device: CZM IOL<br>* implantation of CZM IOL<br>|
| Active Comparator: Competitor IOL<br> | Device: Competitor IOL<br>* implantation of Competitor IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOL axis | IOL axis will be analyzed based on images. | Immediately after the surgery |