Back to resultsEDOF and Multifocal IOL Study
Primary Purpose
Age-related Cataract
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
phacoemulsification and intraocular lens implantation
intraocular lens implantation
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Cataract
Eligibility Criteria
Inclusion Criteria:
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
- Age 50-90
- Visual potential in both eyes of 20/30 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 ocular surgery or trauma
- Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
- Uncontrolled systemic or ocular disease
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Edof IOL vs. multifocal IOL I
Edof IOL vs. multifocal IOL II
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 Edof IOL one (I) vs. multifocal IOL one (I).
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 Edof IOL one (I) vs. multifocal IOL two (II).
Outcomes
Primary Outcome Measures
distant corrected near visual acuity
Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA 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
NCT ID
NCT05573529
First Posted
September 9, 2022
Last Updated
October 10, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05573529
Brief Title
EDOF and Multifocal IOL Study
Official Title
Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
May 8, 2023 (Anticipated)
Study Completion Date
May 8, 2023 (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 Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intra-individual comparison of two groups recieving predefined EDOF and multifocal intraocular lenses. In group one (I), the EDOF lens one (I) will be implanted in the dominant eye and the multifocal lens one (I) in the non-dominant eye. Subsequently, study participants in group two (II) will receive the EDOF lens one (I) in the dominant eye and the multifocal lens two (II) in the non-dominant eye.
Masking
Outcomes Assessor
Masking Description
outcome assessor will be masked to the intraocular lens implanted.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Edof IOL vs. multifocal 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 Edof IOL one (I) vs. multifocal IOL one (I).
Arm Title
Edof IOL vs. multifocal 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 two (II) participants will receive Edof IOL one (I) vs. multifocal IOL two (II).
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
Intervention Type
Device
Intervention Name(s)
intraocular lens implantation
Intervention Description
intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification
Primary Outcome Measure Information:
Title
distant corrected near visual acuity
Description
Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA 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
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
Age 50-90
Visual potential in both eyes of 20/30 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 ocular surgery or trauma
Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
Uncontrolled systemic or ocular disease
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
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Leydolt, MD
Phone
+43140400
Ext
79480
Email
christina.leydolt@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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EDOF and Multifocal IOL Study
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