Reading Performance in Patients With Acrysof IQ Vivity Versus Acrysof IQ
Primary Purpose
Cataract
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
enhanced depth of focus IOL
monofocal IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Cataract surgery, ehanced depth of focus intraocular lens
Eligibility Criteria
Inclusion Criteria:
- Cataract
- Stereopsis
- age 21 and older
- regular corneal astigmatism of up to 3.0 D
- written informed consent prior to surgery
- normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- availability, willingness and sufficient cognitive awareness to comply with examination procedures
- german as mother-tongue
- calculated IOL power needed is below 15.0 D or above 25.0 D (no high myopia or high hypermetropia will be recruited)
Exclusion Criteria:
- relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity that could affect capsule bag stability (e.g. Marfan syndrome) or retinal diseases affecting visual acuity (AMD, Macular Pucker, post-operative macular edema...)
- amblyopia
- contact lenses
- irregular corneal astigmatism on corneal topography
- postoperative subjective refraction smaller/ higher than or 0.75 D
- pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acrysof IQ Vivity
Acrysof IQ
Arm Description
Patient will receive the enhanced depth of focus IOL during cataract surgery
Patiet will receive the monofocal IOL during cataract surgery
Outcomes
Primary Outcome Measures
Reading speed
reading speed will be assessed with the Eyetracker device at 66 centimetres and will be compared between the EDOF IOL and the monofocal IOL
Secondary Outcome Measures
Visual acuity
Visual acuity will be assessed using the ETDRS charts and will be compared between the EDOF IOLs and the monofocal IOLs
Full Information
NCT ID
NCT05194657
First Posted
January 4, 2022
Last Updated
January 4, 2022
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT05194657
Brief Title
Reading Performance in Patients With Acrysof IQ Vivity Versus Acrysof IQ
Official Title
Assessment of Reading Performance in Patients With Acrysof IQ Vivity Toric or Non-toric vs Monofocal Acrysof IQ Toric or Non-toric IOL
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
January 3, 2023 (Anticipated)
Study Completion Date
January 3, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
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
Comparison of the visual function and reading performance between the Acrysof IQ Vivity IOL, an EDOF IOL, and the monofocal Acrysof IQ.
Detailed Description
With increasing demands of patients concerning their visual function after cataract surgery, a variety of advanced technology intraocular lenses (IOL) have become available in the last years. Various developments aim at a reduced spectacle independence for patients after cataract or refractive lens surgery.
Novel technology for providing an extended depth of focus (EDOF) has been developed to account for unmet needs of patients. A novel EDOF IOL, the Acrysof IQ Vivity, has two surface transition elements that work simultaneously by stretching and shifting the wavefront to create a continuous extended focal range instead of multiple focal points.
To assess the performance of such an IOL technology, most studies assess visual acuity at different distances from far, to intermediate up to near. Since most activites with digital devices implicate reading, it is not surprising that reading difficulty is the most common complaint among individuals experiencing visual disturbances with multifocal designs.
Reading ability is usually evaluated using various reading tests that assess reading speed and reading acuity defined as the print size that can stell be read with sufficient speed. However, one of the fundamental problems of these tests is that reading speed is also influenced by the average amount of time that a patient reads as well as the language of the text, whether it is the first or second language.
A novel method to analyse reading performance that appears to be more objective and less reliant on the cognitive abilities of the patient is the observation of the reading pattern using a high-speed eye-tracking system that analyses eye fixations during the reading test. In previous studies we have seen that several aspects of this reading patter, i.e. fixation duration and fixation frequency, appear to correlate with the reading performance overall and can be differentially used to discriminate between cognitive and visuo-motor processing.
Hence, the aim of this study is to assess the visual function and reading performance with an EDOF IOL (Acrysof IQ Vivity) compared to a standard monofocal IOL (Acrysof IQ).
136 eyes of 68 patients will be included into this study. According to the randomization, 34 patients will be implanted with the Acrysof IQ Vivity in both eyes and the other 34 patients will be implanted with the Acrysof IQ in both eyes. A follow-up examination will be performed at 3 months postoperative. During this visit a slitlamp examination, biometry and tomography of the eye, refraction and visual acuity assessment, an OCT examination, a retroillumination photogrypha, reading speed analysis and halometry will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Cataract surgery, ehanced depth of focus intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acrysof IQ Vivity
Arm Type
Experimental
Arm Description
Patient will receive the enhanced depth of focus IOL during cataract surgery
Arm Title
Acrysof IQ
Arm Type
Experimental
Arm Description
Patiet will receive the monofocal IOL during cataract surgery
Intervention Type
Device
Intervention Name(s)
enhanced depth of focus IOL
Intervention Description
Acrysof IQ Vivity, enhanced depth of focus IOL
Intervention Type
Device
Intervention Name(s)
monofocal IOL
Intervention Description
Acrysof IQ, monofocal IOL
Primary Outcome Measure Information:
Title
Reading speed
Description
reading speed will be assessed with the Eyetracker device at 66 centimetres and will be compared between the EDOF IOL and the monofocal IOL
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Visual acuity will be assessed using the ETDRS charts and will be compared between the EDOF IOLs and the monofocal IOLs
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cataract
Stereopsis
age 21 and older
regular corneal astigmatism of up to 3.0 D
written informed consent prior to surgery
normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
availability, willingness and sufficient cognitive awareness to comply with examination procedures
german as mother-tongue
calculated IOL power needed is below 15.0 D or above 25.0 D (no high myopia or high hypermetropia will be recruited)
Exclusion Criteria:
relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity that could affect capsule bag stability (e.g. Marfan syndrome) or retinal diseases affecting visual acuity (AMD, Macular Pucker, post-operative macular edema...)
amblyopia
contact lenses
irregular corneal astigmatism on corneal topography
postoperative subjective refraction smaller/ higher than or 0.75 D
pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahand Amir-Asgari, MD
Phone
01 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Natascha Bayer, MSc
Phone
01 91021
Ext
57564
Email
office@viros.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahand Amir-Asgari, MD
Phone
01 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Natascha Bayer, MSc
Phone
01 91021
Ext
57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reading Performance in Patients With Acrysof IQ Vivity Versus Acrysof IQ
We'll reach out to this number within 24 hrs