Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

Not Applicable

Completed

• Conditions: Intraocular Lens Complication; Cataract Senile
• Interventions: Device: AcrySof™ IQ Vivity™ Toric intraocular lens

• Registration Number: NCT06196593
• Lead Sponsor: LEC Eye Centre

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 Timeline

• Study Start: 2022-04-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-24
• Study First Submitted QC: 2023-12-24
• Last Update Submitted: 2023-12-24
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All eyes	AcrySof™ IQ Vivity™ Toric intraocular lens	All eyes implanted with AcrySof™ IQ Vivity™ Toric intraocular lens

Primary Outcome Measures

Name	Time	Method
Binocular UIVA	3 months	Binocular Uncorrected Intermediate Visual Acuity
Binocular UDVA	3 months	Binocular Uncorrected Distance Visual Acuity
Binocular UNVA	3 months	Binocular Uncorrected Near Visual Acuity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LEC Eye Centre; 🇲🇾 Ipoh, Perak, Malaysia