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Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

Visual Outcomes Following Bilateral Implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06196593
Enrollment
30
Registered
2024-01-09
Start date
2022-04-01
Completion date
2023-04-30
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Senile, Intraocular Lens Complication

Keywords

cataract surgery, intraocular lens, non-diffractive extended depth of focus

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.

Interventions

DEVICEAcrySof™ IQ Vivity™ Toric intraocular lens

Uneventful phacoemulsification and implantation of IOL

Sponsors

Alcon Research
CollaboratorINDUSTRY
LEC Eye Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Binocular UDVA3 monthsBinocular Uncorrected Distance Visual Acuity
Binocular UIVA3 monthsBinocular Uncorrected Intermediate Visual Acuity
Binocular UNVA3 monthsBinocular Uncorrected Near Visual Acuity

Secondary

MeasureTime frameDescription
MRSE3 monthsMean Refractive Spherical Equivalent
Rotational Stability1 monthDegree of rotation of intraocular lens
Binocular Defocus Curve3 monthsMeasurement of the performance of the Intraocular lens at different distances
CDVA3 monthsCorrected Distance Visual Acuity
QUVID3 monthsQuestionnaire on Visual Disturbances
VF-143 monthsVisual function 14 index of questions designed to assess difficulty performing daily visual tasks
Contrast Sensitivity3 monthsMeasurement of the contrast sensitivity after implantation with this intraocular lens
DCIVA3 monthsDistance Corrected Intermediate Visual Acuity
DCNVA3 monthsDistance Corrected Near Visual Acuity

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026