Tolerance to Residual Astigmatism in Eyes With Vivity®

Tolerance to Residual Astigmatism and Defocus in Eyes With a Non-diffractive Extended Depth of Focus (EDoF) Intraocular Lens

Low amounts of postoperative residual astigmatism may worsen the visual performance of patients implanted with presbyopia- correcting intraocular lenses (IOLs). Although extended depth of focus (EDoF) IOLS have introduced optical improvements, it is important to determine the tolerance of these IOLs to postoperative astigmatism. This is important for an appropriate surgical planning.

Therefore, the aim of this study is to simulate and assess the impact of mild amounts of residual mixed astigmatisms with the axis oriented in different positions (vertical, oblique and horizontal) in eyes implanted with the Vivity® IOL.

Study Overview

• Status: Completed
• Conditions: Lenses, Intraocular
• Intervention / Treatment: Device: Cataract surgery with Vivity intraocular lens implantation

Detailed Description

Objectives:

• Primary objective: To describe the tolerance of simulated astigmatism on patients implanted with Vivity at far distance.
• Secondary objective: To describe the tolerance of simulated astigmatism on patients implanted with Vivity at intermediate distance.

Study Design: Prospective, single arm, descriptive, 3-month follow up.

Patient population: 30 consecutive eyes of 30 patients implanted with Vivity bilaterally with no postoperative complications. The calculation of the required sample size was based on monocular corrected distande visual acuity. A difference of 0.2 logMAR units was assumed to be clinically significant anda standard deviation of 0.05 was anticipated(data obtained from a comparative study between a bifocal and a trifocal IOL: Jonker SM, et al. Journal of Cataract Refract Surg. 2015; 41: 1631-40). Based on these assumptions, with an α of 0.05 and power of 0.8, it was calculated that 25 eyes were required in each group. Due to potential dropouts, a larger sample size has been selected.

Clinical Protocol: All patients fullfilling study criteria will be considered for inclusion three months after surgery. After patient consent, uncorrected distance visual acuity will be measured with an ETDRS chart, followed by subjective refraction (best distance correction). In all cases, mixed astigmatism will be induced with trial lens over the best distance corrected situation (considered the reference situation).

Once the best distance correction is determined, the different visual acuity evaluation procedures for this study will be performed with a Freiburg Acuity Test software package. The software will be run on a separate laptop screen calibrated to be presented at 4 meters. In this procedure, a black Landolt C is presented to the subjects and, among 8 different possibilities, they indicate the orientation of the optotype on a numeric keypad. This test minimizes the observer's bias because the presented optotype depends on the patient´s previous responses. That is, when the observer responds to a certain optotype, the software automatically modifies the size of the next optotype according to parameter estimation by a sequential test method. (7,8) Finally, all serious adverse events will be reported.

Statistical Analysis: Visual acuity values will be expressed as mean and standard deviation. Normal distribution of variables will be assessed using the Kolmogorov- Smirnov test. Pre- and post-operative data of each parameter will be compared by means of the Student's t-test. A repeated measure analysis of variance (ANOVA) will be used to gauge any statistically significant difference of the data within the different simulated situations. Differences are considered to be statistically significant for P value <0.05 (i.e., at the 5% level).

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28010
    • Clinica Rementeria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing bilateral cataract surgery with bilateral Vivity intraocular lens implantation, with no other ocular diseases and no complications

Description

Inclusion Criteria:

• Patients >40 years old that undergo routine cataract surgery
• Bilateral implantation of Vivity ® IOL

Exclusion Criteria:

• Corneal astigmatism ≥1.0 diopters (D )
• Amblyopia
• Previous ocular surgery
• Presence of ocular pathologies
• Abnormal iris
• Patients with intra- or postoperative complications
• Postoperative best distance corrected visual acuity (BDCVA) < 20/20
• Postoperative refractive astigmatism > 0.50D

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Vivity patients; The study will include patients >40 years old that undergo routine cataract surgery and implantation of Vivity ®. Exclusion criteria include corneal astigmatism ≥1.0 diopters (D ), amblyopia, previous ocular surgery and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative best distance corrected visual acuity (BDCVA) < 20/20 and with postoperative refractive astigmatism > 0.50D will be also excluded . Inclusion and exclusion criteria will be assessed by an ophthalmologic examination including refraction, screening for ocular conditions and/or systemic diseases, slit-lamp biomicroscopy and fundus examination.

Device: Cataract surgery with Vivity intraocular lens implantation; Cataract surgery with Vivity intraocular lens implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Against the Rule Astimatism	Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x0*, taking as a reference the subjects' axis	Three months after surgery
Distance Oblique Astigmatism	Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x45*, taking as a reference the subjects' axis	Three months after surgery
Distance With the Rule Astigmatism	Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x90*, taking as a reference the subjects' axis	Three months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermediate against the rule astigmatism	Change from baseline condition in the simulated (with -1.50 D) Monocular intermediate visual acuity inducing astigmatism of +0.25-0.50x0*	Three months after surgery
Intermediate oblique astigmatism	Change from baseline condition in the simulated (with -1.50 D) Monocular intermediate visual acuity inducing astigmatism of +0.25-0.50x45*	Three months after surgery
Intermediate with the rule astigmatism	Change from baseline condition in the simulated (with -1.50 D) Monocular intermediate visual acuity inducing astigmatism of +0.25-0.50x90*	Three months after surgery

Collaborators and Investigators

• Sponsor: Clínica Rementería
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Laureano Rementeria-Capelo, MD, Clinica Rementeria

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): March 9, 2022
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: astigmatism; extended depth of focus intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 21/365-O_P_Viv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared after reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes