Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)

ConditionCataract Senile

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCarl Zeiss Meditec AG

About this trial

Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)

Eligibility criteria

Qualifiers

Patients of any gender, aged 18 years or older

Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement

Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)

Calculated lens power within the available range

Disqualifiers

Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)

Endothelial cell count of less than 2000/mm2

Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.

Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study