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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

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

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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

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)




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 ]


Information from the National Library of Medicine

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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
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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