NCT06196593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

December 24, 2023

Last Update Submit

December 24, 2023

Conditions

Cataract SenileIntraocular Lens Complication

Keywords

cataract surgeryintraocular lensnon-diffractive extended depth of focus

Outcome Measures

Primary Outcomes (3)

  • 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 (9)

  • CDVA

    3 months

  • DCIVA

    3 months

  • DCNVA

    3 months

  • MRSE

    3 months

  • Rotational Stability

    1 month

  • +4 more secondary outcomes

Study Arms (1)

All eyes

EXPERIMENTAL

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

Device: AcrySof™ IQ Vivity™ Toric intraocular lens

Interventions

AcrySof™ IQ Vivity™ Toric intraocular lensDEVICE

Uneventful phacoemulsification and implantation of IOL

All eyes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LEC Eye Centre

Ipoh, Perak, 30450, Malaysia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

December 24, 2023

First Posted

January 9, 2024

Study Start

April 1, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

January 9, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)