Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: Trifocal Intraocular Lens Device: Bifocal Intraocular Lens Device: Low Addition Bifocal Intraocular Lens Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : October 2015
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 809M
bifocal intraocular lens (IOL)
 Device: Bifocal Intraocular Lens
trifocal intraocular lens (IOL)
Active Comparator: 839MP
trifocal intraocular lens (IOL)
 Device: Trifocal Intraocular Lens
bifocal intraocular lens (IOL)
Active Comparator: SN6AD1
bifocal intraocular lens (IOL)
 Device: Low Addition Bifocal Intraocular Lens
low near addition intraocular lens (IOL)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Intermediate visual acuity [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Distance visual acuity [ Time Frame: 12 months ]
  2. Near visual acuity [ Time Frame: 12 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT02990689    
Other Study ID Numbers: LISA tri 839MP HEN 301-11
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018