Visual Outcomes Following Bilateral Implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens
Phase: NA
Conditions: Cataract Senile, Intraocular Lens Complication
Sponsor: LEC Eye Centre

 Investigator Initiated Trial Proposal – AcrysofTM IQ VivityTM Toric 
Date: 24/12/21 
Title:  Visual outcomes following implantation of the Acrysof TM IQ VivityTM Toric Extended 
Vision Intraocular Lens 
Setting:  LEC Eye Centre, Ipoh, Malaysia 
Background:   The AcrysofTM IQ VivityTM is a new non-diffractive, UV-absorbing and blue light 
filtering hydrophobic aspheric intraocular lens (IOL) which has been reported to provide an 
extended range of vision from distance to near with a low incidence of visual disturbances. The 
toric version also compensates for corneal astigmatism.  
Objective:  The primary objective of this study is to evaluate the clinical outcomes following 
implantation of the AcrysofTM IQ VivityTM Toric Extended Vision IOL. Secondary objectives will 
include level of spectacle independence as well as the tolerance to residual astigmatism or refractive 
error. 
  
Design:  This is a single-centre prospective interventional study of patients with significant 
cataract and subsequent bilateral implantations of the AcrysofTM IQ VivityTM Toric Extended 
Vision IOL. All eyes will have a refractive target of emmetropia with the IOL power which provides 
the first myopic target closest to emmetropia selected for implantation. Visual outcomes will be 
assessed up to 3 months after surgery. Target sample size will be 60 eyes of 30 patients. 
 
Primary outcome measures at 3 months: 
1. Binocular uncorrected distance, intermediate (66cm) and near (40cm) acuities. Visual 
acuity scores will be converted to logMAR for analysis. 
2. VF-14 Quality of Life questionnaire 
3. Questionnaire for Visual Disturbance (QUVID)  
 
Secondary outcome measures: 
1. Uncorrected distance, intermediate (66cm) and near (40cm) acuities 
2. Best corrected distance acuity, distance corrected intermediate acuity and distance 
corrected near acuity 
3. Monocular and Binocular Defocus Curve  
4. Refractive predictability and stability 
5. Rotational stability of IOL  
6. Vector analysis of astigmatic correction 
7. Mesopic and photopic Contrast Sensitivity with CSV 1000  
 
Inclusion Criteria:  
- 
Patients with visually significant cataracts in both eyes and significant pre-existing 
corneal astigmatism (as determined by the Barrett Toric Calculator) planned for 
phacoemulsification and implantation of AcrysofTM IQ VivityTM Toric Extended Vision 
IOL 
- 
Patients aged 18 years or older  
Exclusion Criteria: 
- 
Eyes with other ocular pathology which may significantly impact visual acuity (e.g. 
moderate to advanced age related macular degeneration, centre-involving diabetic 
maculopathy, moderate to advanced glaucoma, keratoconus, corneal dystrophy, etc) 
- 
Eyes with amblyopia or strabismus 
- 
Eyes with pre-existing zonular weakness or capsular compromise 
- 
Eyes with intraoperative capsular rupture 

- 
Eyes which had previously undergone refractive surgery 
 
Study Plan:  Study procedures will be conducted prospectively and results entered into a 
database created for the purpose of this study. 
 
Schedule of Visits:  
Procedure 
Preop 
Day 0 
POD 1 
POD 7 
POD 1m 
POD 3m 
Demographics 
Ö 
 
 
 
 
 
Medical/Ocular History 
Ö 
 
 
 
 
 
Manifest Refraction 
Ö 
 
 
Ö 
Ö 
Ö 
UCVA 
Ö 
 
Ö 
Ö 
Ö 
Ö 
BCVA 
Ö 
 
 
Ö 
Ö 
Ö 
Slit lamp examination 
Ö 
 
Ö 
Ö 
Ö 
Ö 
Dilated fundus examination 
Ö 
 
 
 
Ö 
Ö 
Biometry 
Ö 
 
 
 
 
 
IOL position 
 
 
 
Ö 
Ö 
 
VF-14 
 
 
 
 
 
Ö 
Contrast Sensitivity 
 
 
 
 
 
Ö 
QUVID 
 
 
 
 
Ö 
Ö 
Adverse Events 
 
Ö 
Ö 
Ö 
Ö 
Ö 
 
 
Data Analysis:  Descriptive statistics will be computed using Microsoft Excel and astigmatic 
analysis will be done using the ASSORT calculator.  
 
Timeline and publication plan: 
Items 
Estimated timelines 
 
 
IRB Submission 
July 2021 
Contracting 
October 2021  
First Patient First Visit  
October 2021  
Last Patient Last Visit 
March 2022 
Data Processing and Analysis 
April 2022 
Final Report 
May 2022 
Publication plans 
3rd quarter 2022 
Presentation plans 
APACRS 2022, ESCRS 2022, AAO 2022, ASCRS 
2023, APAO 2023