Status:
COMPLETED
To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses
Lead Sponsor:
Carl Zeiss Meditec AG
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2021
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03839420
Start Date
July 8 2019
End Date
February 17 2021
Last Update
February 8 2023
Active Locations (1)
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1
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany