Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

NCT ID: NCT06196593

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-04-30

Brief Summary

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The objective of this study was to evaluate the clinical and patient reported outcomes after bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens.

Detailed Description

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This is a prospective interventional case series of 30 patients who underwent cataract surgery and bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens. This study is represented by an Asian cohort of patients and the study evaluations were focused not only on clinical visual outcomes but also on "real-life" patient reported outcomes such as dysphotopsias, spectacle independence and daily visual tasks all of which were measured at 1 month and up to 3 months postoperatively. The objective would be to provide insight into the performance of this intraocular lens in Asian patients.

Conditions

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Cataract Senile Intraocular Lens Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All eyes

All eyes implanted with AcrySof™ IQ Vivity™ Toric intraocular lens

Group Type EXPERIMENTAL

AcrySof™ IQ Vivity™ Toric intraocular lens

Intervention Type DEVICE

Uneventful phacoemulsification and implantation of IOL

Interventions

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AcrySof™ IQ Vivity™ Toric intraocular lens

Uneventful phacoemulsification and implantation of IOL

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients aged 18 years or older
* bilateral significant cataracts
* bilateral significant corneal astigmatism

Exclusion Criteria

* previous refractive surgery
* amblyopia
* strabismus
* any ocular co-morbidity which could impact on final visual acuity
* pre-existing zonular weakness
* capsular instability or compromise
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

LEC Eye Centre

OTHER

Sponsor Role lead

Responsible Party

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Mun Wai Lee

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LEC Eye Centre

Ipoh, Perak, Malaysia

Site Status

Countries

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Malaysia

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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VTLEC

Identifier Type: -

Identifier Source: org_study_id

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