Prospective randomized clinical trial comparing early rotation of two extended depth of focus intraocular lenses - VENUS toric

Carl Zeiss Meditec AG0 sites153 target enrollmentDecember 28, 2021

Conditionscataract

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: cataract
Sponsor: Carl Zeiss Meditec AG
Enrollment: 153
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 28, 2021

End Date

February 17, 2021

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Carl Zeiss Meditec AG

Eligibility Criteria

Inclusion Criteria

•1\. Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent
•2\. Patients of any gender, aged 45 or older
•3\. Assured follow\-up examinations
•4\. Eyes with clinically significant age related cataract requiring surgical treatment, otherwise healthy
•5\. Corrected distance visual acuity projected to be better than 0\.2 logMAR after the cataract surgery, as determined by Investigator’s medical judgment
•6\. Calculated IOL power is within SE \+14\.0 D and \+30\.0 D (in 0\.5 diopter increments) and between a cylindrical range of \+1\.0 D to \+4\.0 D, in the study eye(s).
•7\. Uni\- and/or bilaterally regular corneal astigmatism confirmed by topography measurement
•8\. Cataract density compatible with biometry measurement
•9\. In case both eyes will be included, patient agreed to have surgery of the second eye performed between 1 day and 1 month after the surgery of the first eye.

Exclusion Criteria

•10\. Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non\-cooperation during the trial
•11\. Patients whose freedom is impaired by administrative or legal order
•12\. Current systemic or ocular pharmacotherapy that may interfere with the conductance of the trial in the opinion of the investigator. (e.g. Chloroquine and Hydroxychloroquine (Maculopathy), Tamoxifen (Retinopathy), Ethambutol (Optic Neuropathy)
•13\. 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
•14\. Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
•15\. Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
•16\. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
•17\. Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
•18\. 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
•19\. Pseudoexfoliation syndrome (according to investigator decision)