Tolerance to Residual Astigmatism in Eyes With Vivity®

NCT ID: NCT05392998

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2022-03-09

Brief Summary

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.

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).

Conditions

Lenses, Intraocular

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cataract surgery with Vivity intraocular lens implantation

Intervention Type: DEVICE

Cataract surgery with Vivity intraocular lens implantation

Interventions

Cataract surgery with Vivity intraocular lens implantation

Cataract surgery with Vivity intraocular lens implantation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Clínica Rementería

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laureano Rementeria-Capelo, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica Rementería

Locations

Clínica Rementería

Madrid, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21/365-O_P_Viv

Identifier Type: -

Identifier Source: org_study_id