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Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990689
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG

Tracking Information
First Submitted Date  ICMJE December 6, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date September 6, 2018
Study Start Date  ICMJE March 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
Intermediate visual acuity [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • Distance visual acuity [ Time Frame: 12 months ]
  • Near visual acuity [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Visual Acuity
Intervention  ICMJE
  • Device: Trifocal Intraocular Lens
    bifocal intraocular lens (IOL)
  • Device: Bifocal Intraocular Lens
    trifocal intraocular lens (IOL)
  • Device: Low Addition Bifocal Intraocular Lens
    low near addition intraocular lens (IOL)
Study Arms  ICMJE
  • Active Comparator: 809M
    bifocal intraocular lens (IOL)
    Intervention: Device: Bifocal Intraocular Lens
  • Active Comparator: 839MP
    trifocal intraocular lens (IOL)
    Intervention: Device: Trifocal Intraocular Lens
  • Active Comparator: SN6AD1
    bifocal intraocular lens (IOL)
    Intervention: Device: Low Addition Bifocal Intraocular Lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2016)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients of any gender, aged 50 to 80 years
  • Signed informed consent form
  • Healthy eyes besides cataract
  • Assured follow-up examinations
  • Stable corneal conditions within the last 12 months
  • Corneal astigmatism less than 1D
  • Implantation into the capsular bag by injector

Exclusion Criteria:

  • Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
  • Pseudophakia
  • Cornea guttata; keratoplasty
  • Irregular astigmatism (e.g. Keratoconus)
  • Corneal scarring
  • Diabetic retinopathy
  • Aniridia
  • Amblyopia
  • Amotio operation; anamnesis with vitreous surgery
  • Pseudoexfoliation Syndrome; Uveitis
  • Previous intraocular and corneal surgery
  • Intraocular tumours; endotamponade
  • Glaucoma or IOP higher than 24mmHg
  • Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
  • Need for a dioptre out of the range of +16.0D to +26.0D
  • Inability to achieve secure lens placement in the capsular bag
  • Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
  • Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
  • Pregnancy or lactation period for female patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990689
Other Study ID Numbers  ICMJE LISA tri 839MP HEN 301-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carl Zeiss Meditec AG
Study Sponsor  ICMJE Carl Zeiss Meditec AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Carl Zeiss Meditec AG
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP