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Clinical Trials/NCT06196593
NCT06196593
Completed
Not Applicable

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

LEC Eye Centre1 site in 1 country30 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract Senile
Sponsor
LEC Eye Centre
Enrollment
30
Locations
1
Primary Endpoint
Binocular UIVA
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
April 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
LEC Eye Centre
Responsible Party
Principal Investigator
Principal Investigator

Mun Wai Lee

Medical Director

LEC Eye Centre

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

Outcomes

Primary Outcomes

Binocular UIVA

Time Frame: 3 months

Binocular Uncorrected Intermediate Visual Acuity

Binocular UDVA

Time Frame: 3 months

Binocular Uncorrected Distance Visual Acuity

Binocular UNVA

Time Frame: 3 months

Binocular Uncorrected Near Visual Acuity

Secondary Outcomes

  • Rotational Stability(1 month)
  • Binocular Defocus Curve(3 months)
  • DCNVA(3 months)
  • MRSE(3 months)
  • VF-14(3 months)
  • CDVA(3 months)
  • DCIVA(3 months)
  • Contrast Sensitivity(3 months)
  • QUVID(3 months)

Study Sites (1)

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