Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05194657 |
| Other study ID # |
Vivity |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2022 |
| Est. completion date |
January 3, 2024 |
Study information
| Verified date |
January 2022 |
| Source |
Vienna Institute for Research in Ocular Surgery |
| Contact |
Sahand Amir-Asgari, MD |
| Phone |
01 91021 |
| Email |
office[@]viros.at |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Comparison of the visual function and reading performance between the Acrysof IQ Vivity IOL,
an EDOF IOL, and the monofocal Acrysof IQ.
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.
