Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

September 4, 2018 updated by: Carl Zeiss Meditec AG
The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intermediate visual acuity
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Distance visual acuity
Time Frame: 12 months
12 months
Near visual acuity
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl Zeiss Meditec AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • LISA tri 839MP HEN 301-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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