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Intraindividual Comparison of EMO IOLs (EMO)

Primary Purpose

Age Related Cataracts

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
phacoemulsification and intraocular lens implantation
phacoemulsification and intraocular lens implantation
phacoemulsification and intraocular lens implantation
phacoemulsification and intraocular lens implantation
phacoemulsification and intraocular lens implantation
phacoemulsification and intraocular lens implantation
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Cataracts

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation Age 50 to 100 Visual potential in both eyes of 20/25 or better as determined by investigators estimation Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Preceding intraocular surgery or ocular trauma Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma) Pupil diameter < 2.0 mm (photopic) Laser treatment Uncontrolled systemic or ocular disease Pregnancy/Nursing childbearing ability

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Monofocal IOL I vs. enhanced monofocal IOL I

Monofocal IOL II vs. enhanced monofocal IOL I

Monofocal IOL III vs. enhanced monofocal IOL II

Enhanced monofocal IOL II vs. enhanced monofocal IOL II

Monofocal IOL III vs. enhanced monofocal IOL IV

Enhanced Monofocal IOL V vs. enhanced monofocal IOL V with irregular astigmatism

Arm Description

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00)

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress).

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (V) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (VI) participants will receive an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed.

Outcomes

Primary Outcome Measures

Distant corrected intermediate visual acuity
Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL
Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted and eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2023
Last Updated
October 17, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05822089
Brief Title
Intraindividual Comparison of EMO IOLs
Acronym
EMO
Official Title
Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

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

5. Study Description

Brief Summary
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intra-individual comparison of 5 groups receiving predefined monofocal and enhanced monofocal intraocular lenses (EMO IOLs). Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the dominant eye and the other IOL type in the non- dominant eye.
Masking
Outcomes Assessor
Masking Description
outcome assessor will be masked to the intraocular lens implanted
Allocation
Non-Randomized
Enrollment
283 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monofocal IOL I vs. enhanced monofocal IOL I
Arm Type
Experimental
Arm Description
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)
Arm Title
Monofocal IOL II vs. enhanced monofocal IOL I
Arm Type
Experimental
Arm Description
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00)
Arm Title
Monofocal IOL III vs. enhanced monofocal IOL II
Arm Type
Experimental
Arm Description
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress).
Arm Title
Enhanced monofocal IOL II vs. enhanced monofocal IOL II
Arm Type
Experimental
Arm Description
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target
Arm Title
Monofocal IOL III vs. enhanced monofocal IOL IV
Arm Type
Experimental
Arm Description
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (V) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)
Arm Title
Enhanced Monofocal IOL V vs. enhanced monofocal IOL V with irregular astigmatism
Arm Type
Experimental
Arm Description
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (VI) participants will receive an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed.
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification and intraocular lens implantation
Intervention Description
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification and intraocular lens implantation
Intervention Description
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00)
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification and intraocular lens implantation
Intervention Description
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress)
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification and intraocular lens implantation
Intervention Description
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification and intraocular lens implantation
Intervention Description
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification and intraocular lens implantation
Intervention Description
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Acrysof IQ Vivity) in both eyes if irregular astigmatism is observed
Primary Outcome Measure Information:
Title
Distant corrected intermediate visual acuity
Description
Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Time Frame
2-6 months
Title
Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL
Description
Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted and eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Time Frame
3-5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation Age 50 to 100 Visual potential in both eyes of 20/25 or better as determined by investigators estimation Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: Preceding intraocular surgery or ocular trauma Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma) Pupil diameter < 2.0 mm (photopic) Laser treatment Uncontrolled systemic or ocular disease Pregnancy/Nursing childbearing ability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Leydolt, MD
Phone
+43 (01) 40 400 79480
Email
christina.leydolt@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Leydolt, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Leydolt, MD
Phone
+4314040079480
Email
christina.leydolt@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Intraindividual Comparison of EMO IOLs

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