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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06196593
Other study ID # VTLEC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date April 30, 2023

Study information

Verified date December 2023
Source LEC Eye Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AcrySof™ IQ Vivity™ Toric intraocular lens
Uneventful phacoemulsification and implantation of IOL

Locations

Country Name City State
Malaysia LEC Eye Centre Ipoh Perak

Sponsors (2)

Lead Sponsor Collaborator
LEC Eye Centre Alcon Research

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Binocular UDVA Binocular Uncorrected Distance Visual Acuity 3 months
Primary Binocular UIVA Binocular Uncorrected Intermediate Visual Acuity 3 months
Primary Binocular UNVA Binocular Uncorrected Near Visual Acuity 3 months
Secondary CDVA Corrected Distance Visual Acuity 3 months
Secondary DCIVA Distance Corrected Intermediate Visual Acuity 3 months
Secondary DCNVA Distance Corrected Near Visual Acuity 3 months
Secondary MRSE Mean Refractive Spherical Equivalent 3 months
Secondary Rotational Stability Degree of rotation of intraocular lens 1 month
Secondary Binocular Defocus Curve Measurement of the performance of the Intraocular lens at different distances 3 months
Secondary Contrast Sensitivity Measurement of the contrast sensitivity after implantation with this intraocular lens 3 months
Secondary QUVID Questionnaire on Visual Disturbances 3 months
Secondary VF-14 Visual function 14 index of questions designed to assess difficulty performing daily visual tasks 3 months
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