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EDoF IOLs vs Monofocal IOL

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ClinicalTrials.gov Identifier: NCT03172351
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG

Brief Summary:
prospective, comparative (3 arms), randomized, multicentric clinical trial

Condition or disease Intervention/treatment Phase
Cataract Device: EDoF1 Device: Monofocal Device: EDoF2 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019

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




Primary Outcome Measures :
  1. Defocus curve measurement [ Time Frame: 1 month ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172351


Contacts
Contact: Carl Zeiss Meditec AG +49 30 854 001 ext 0 clinicalstudies.meditec.sur@zeiss.com

Locations
Germany
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany
Contact: UNIVERSITÄTSKLINIKUM FREIBURG         
Sponsors and Collaborators
Carl Zeiss Meditec AG

Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT03172351     History of Changes
Other Study ID Numbers: AT LARA 829MP BER-401-16
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases