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OpenTrials
Completed

NCT Number: NCT06196593

Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

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.

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Key information

Conditions

Cataract Senile Intraocular Lens Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LEC Eye Centre

Ipoh, Perak, 30450, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AcrySof™ IQ Vivity™ Toric intraocular lens

Device

Uneventful phacoemulsification and implantation of IOL

Primary outcomes

  1. Binocular UDVA

    Time frame: 3 months

    Binocular Uncorrected Distance Visual Acuity

  2. Binocular UIVA

    Time frame: 3 months

    Binocular Uncorrected Intermediate Visual Acuity

  3. Binocular UNVA

    Time frame: 3 months

    Binocular Uncorrected Near Visual Acuity

Secondary outcomes

  1. CDVA

    Time frame: 3 months

    Corrected Distance Visual Acuity

  2. DCIVA

    Time frame: 3 months

    Distance Corrected Intermediate Visual Acuity

  3. DCNVA

    Time frame: 3 months

    Distance Corrected Near Visual Acuity

  4. MRSE

    Time frame: 3 months

    Mean Refractive Spherical Equivalent

  5. Rotational Stability

    Time frame: 1 month

    Degree of rotation of intraocular lens

  6. Binocular Defocus Curve

    Time frame: 3 months

    Measurement of the performance of the Intraocular lens at different distances

  7. Contrast Sensitivity

    Time frame: 3 months

    Measurement of the contrast sensitivity after implantation with this intraocular lens

  8. QUVID

    Time frame: 3 months

    Questionnaire on Visual Disturbances

  9. VF-14

    Time frame: 3 months

    Visual function 14 index of questions designed to assess difficulty performing daily visual tasks

Sponsors and collaborators

Lead sponsor

LEC Eye Centre

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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