Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06196593
• Other study ID #: VTLEC
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile
• Intraocular Lens Complication

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