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Clinical Trials/NCT06196593
NCT06196593CompletedNot Applicable

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

LEC Eye Centre2 sites in 1 country30 target enrollmentStarted: April 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Binocular UIVA

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

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)

Investigators

Sponsor
LEC Eye Centre
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mun Wai Lee

Medical Director

LEC Eye Centre

Study Sites (2)

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