NCT05392998

Tolerance to Residual Astigmatism in Eyes With Vivity®

Completed Results posted Last updated 18 March 2024

What this trial tests

trial testing Cataract surgery with Vivity intraocular lens implantation in Lenses, Intraocular in 30 participants. Completed in 9 March 2022.

Timeline

16 June 2021

Primary endpoint
9 March 2022

9 March 2022

Quick facts

Lead sponsor	Clínica Rementería
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	16 June 2021
Primary completion	9 March 2022
Estimated completion	9 March 2022
Sites	1 location across Spain

Drugs / interventions tested

• Cataract surgery with Vivity intraocular lens implantation

Conditions studied

• Lenses, Intraocular — all drugs for Lenses, Intraocular →

Sponsor

Clínica Rementería

Who can join

Adults 40 to 90, any sex, with Lenses, Intraocular. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Distance Against the Rule Astimatism Primary · Three months after surgery

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

Group	Value	95% CI
Vivity Patients	0.01	± 0.04

Distance Oblique Astigmatism Primary · Three months after surgery

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

Group	Value	95% CI
Vivity Patients	0.01	± 0.06

Distance With the Rule Astigmatism Primary · Three months after surgery

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

Group	Value	95% CI
Vivity Patients	0.01	± 0.05

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Visual Performance of Eyes with Residual Refractive Errors after Implantation of an Extended Vision Intraocular Lens.
   Rementería-Capelo LA, Contreras I, Morán A, Lorente-Hevia P, et al · · 2023 · cited 3× · PMID 37180814 · DOI 10.1155/2023/7701390