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EDoF IOLs vs Monofocal IOL

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
EDoF1
Monofocal
EDoF2
Sponsored by
Carl Zeiss Meditec AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zeiss Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

EDoF1

Monofocal

EDoF2

Arm Description

Outcomes

Primary Outcome Measures

Defocus curve measurement

Secondary Outcome Measures

Full Information

First Posted
May 24, 2017
Last Updated
July 15, 2020
Sponsor
Carl Zeiss Meditec AG
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1. Study Identification

Unique Protocol Identification Number
NCT03172351
Brief Title
EDoF IOLs vs Monofocal IOL
Official Title
Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carl Zeiss Meditec AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EDoF1
Arm Type
Experimental
Arm Title
Monofocal
Arm Type
Active Comparator
Arm Title
EDoF2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
EDoF1
Intervention Description
extended depth of focus IOL - EDoF1
Intervention Type
Device
Intervention Name(s)
Monofocal
Intervention Description
Monofocal IOL
Intervention Type
Device
Intervention Name(s)
EDoF2
Intervention Description
Comparison EDoF2 IOL
Primary Outcome Measure Information:
Title
Defocus curve measurement
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Zeiss Study Site
City
Freiburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32915276
Citation
Reinhard T, Maier P, Bohringer D, Bertelmann E, Brockmann T, Kiraly L, Salom D, Piovella M, Colonval S, Mendicute J. Comparison of two extended depth of focus intraocular lenses with a monofocal lens: a multi-centre randomised trial. Graefes Arch Clin Exp Ophthalmol. 2021 Feb;259(2):431-442. doi: 10.1007/s00417-020-04868-5. Epub 2020 Sep 11.
Results Reference
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EDoF IOLs vs Monofocal IOL

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