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EDoF IOLs vs Monofocal IOL

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Completed
CT.gov ID
NCT03172351
Collaborator
(none)
216
Enrollment
1
Location
3
Arms
22.2
Actual Duration (Months)
9.7
Patients Per Site Per Month

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
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

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

Sponsors and Collaborators

  • Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT03172351
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:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jul 16, 2020