Tolerance to Residual Astigmatism in Eyes With Vivity®

Lenses, Intraocular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05392998
• Other study ID #: 21/365-O_P_Viv
• Status: Completed
• Start date: June 16, 2021
• Est. completion date: March 9, 2022

Study information

• Verified date: August 2023
• Source: Clínica Rementería
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Lenses, Intraocular

Intervention

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

Locations

Country	Name	City	State
Spain	Clínica Rementería	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Clínica Rementería	Alcon Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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