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Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Completed
CT.gov ID
NCT02990689
Collaborator
(none)
55
Enrollment
3
Arms
43
Duration (Months)

Study Details

Study Description

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
  • Device: Trifocal Intraocular Lens
  • Device: Bifocal Intraocular Lens
  • Device: Low Addition Bifocal Intraocular Lens
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

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

Primary Outcome Measures

  1. Intermediate visual acuity [12 months]

Secondary Outcome Measures

  1. Distance visual acuity [12 months]

  2. Near visual acuity [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

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:
NCT02990689
Other Study ID Numbers:
  • LISA tri 839MP HEN 301-11
First Posted:
Dec 13, 2016
Last Update Posted:
Sep 6, 2018
Last Verified:
Sep 1, 2018

Study Results

No Results Posted as of Sep 6, 2018