EDoF IOLs vs Monofocal IOL

July 15, 2020 updated by: Carl Zeiss Meditec AG

Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens

prospective, comparative (3 arms), randomized, multicentric clinical trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany
        • Zeiss Study Site

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:

  • Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent;
  • Patients of any gender, aged 50 to 80 years;
  • Assured follow-up examinations;
  • clinically significant bilateral cataract;

Exclusion Criteria:

  • Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial;
  • Patients whose freedom is impaired by administrative or legal order;
  • Current participation in another drug or device investigation;
  • Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
  • Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
  • Pseudoexfoliations syndrome
  • Pathologic miosis or Pharmacotherapy with miotic agent
  • Keratoconus
  • Chronic or recurrent uveitis
  • Diabetic retinopathy
  • Uncontrolled glaucoma and or IOP>24mmHg
  • Choroidal hemorrhage,
  • All kind of infections (acute ocular disease, external/internal infection, systemic infection)
  • Traumatic cataract
  • Aniridia
  • Microphthalmia
  • Amblyopia
  • Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
  • Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up
  • Previous intraocular and corneal surgery
  • Expected postop. astigmatism greater than 1 D
  • Any type of corneal disorder
  • Systemic or ocular pharmacotherapy, which can impact the visual acuity,
  • Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion
  • Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)
  • Dementia
  • 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
Experimental: EDoF1
Device: Monofocal
Monofocal IOL
Device: EDoF2
Comparison EDoF2 IOL
Active Comparator: Monofocal
Device: EDoF2
Comparison EDoF2 IOL
Device: EDoF1
extended depth of focus IOL - EDoF1
Active Comparator: EDoF2
Device: Monofocal
Monofocal IOL
Device: EDoF1
extended depth of focus IOL - EDoF1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Defocus curve measurement
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Carl Zeiss Meditec AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 24, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 29, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT LARA 829MP BER-401-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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