EDoF IOLs vs Monofocal IOL

Launched by CARL ZEISS MEDITEC AG · May 29, 2017

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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