EDoF IOLs vs Monofocal IOL

Carl Zeiss Meditec AG (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

prospective, comparative (3 arms), randomized, multicentric clinical trial

Condition or Disease Intervention/Treatment Phase
  • Device: EDoF1
  • Device: Monofocal
  • Device: EDoF2

Study Design

Study Type:
Actual Enrollment :
216 participants
Intervention Model:
Parallel Assignment
Double (Participant, Outcomes Assessor)
Primary Purpose:
Official Title:
Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens
Actual Study Start Date :
May 24, 2017
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: EDoF1

Device: Monofocal
Monofocal IOL

Device: EDoF2
Comparison EDoF2 IOL

Active Comparator: Monofocal

Device: EDoF1
extended depth of focus IOL - EDoF1

Device: EDoF2
Comparison EDoF2 IOL

Active Comparator: EDoF2

Device: EDoF1
extended depth of focus IOL - EDoF1

Device: Monofocal
Monofocal IOL

Outcome Measures

Primary Outcome Measures

  1. Defocus curve measurement [1 month]

Eligibility Criteria


Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Zeiss Study Site Freiburg Germany

Sponsors and Collaborators

  • Carl Zeiss Meditec AG


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • AT LARA 829MP BER-401-16
First Posted:
Jun 1, 2017
Last Update Posted:
Jul 16, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2020