Reading Performance in Patients With Acrysof IQ Vivity Versus Acrysof IQ

Cataract Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194657
• Other study ID #: Vivity
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• enhanced depth of focus IOL
Acrysof IQ Vivity, enhanced depth of focus IOL
• monofocal IOL
Acrysof IQ, monofocal IOL

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Secondary	Visual acuity	Visual acuity will be assessed using the ETDRS charts and will be compared between the EDOF IOLs and the monofocal IOLs	24 months