Visual Outcomes Following Bilateral Implantation of the V... | NCT06196593

Studies
Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

NCT06196593

Sponsor

LEC Eye Centre

Status

Completed

Last Update Posted

Jan 9, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Cataract Senile
Intraocular Lens Complication

Interventions

AcrySof™ IQ Vivity™ Toric intraocular lens

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Apr 30, 2023Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Dec 24, 2023

First Submission Date that Met QC Criteria

Dec 24, 2023

First Posted Date

Jan 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2023

Last Update Posted Date

Jan 9, 2024Actual

Name	Class
Alcon Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All eyes	Experimental	All eyes implanted with AcrySof™ IQ Vivity™ Toric intraocular lens	Device: AcrySof™ IQ Vivity™ Toric intraocular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AcrySof™ IQ Vivity™ Toric intraocular lens	Device	Uneventful phacoemulsification and implantation of IOL	All eyes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Binocular UDVA	Binocular Uncorrected Distance Visual Acuity	3 months
Binocular UIVA	Binocular Uncorrected Intermediate Visual Acuity	3 months
Binocular UNVA	Binocular Uncorrected Near Visual Acuity	3 months

Secondary Outcomes

Measure	Description	Time Frame
CDVA	Corrected Distance Visual Acuity	3 months
DCIVA	Distance Corrected Intermediate Visual Acuity	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LEC Eye Centre		Ipoh	Perak	30450	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided