Posters

Spectacle independence after bilateral implantation of a new non-diffractive presbyopia-correcting intraocular lens

Poster Details

First Author: R.Mesa SPAIN

Co Author(s):    A. Martinez   M. Guarro                 

Abstract Details

Purpose:

To evaluate spectacle independence following implantation of a new non-diffractive presbyopia-correcting intraocular lens (IOL), AcrySof® IQ Vivity IOL (model DFT015) versus an aspheric monofocal IOL (model SN60WF).

Setting:

Nineteen investigational sites located in Australia (3 sites), Canada (6 sites), Spain (6 sites) and the UK (4 sites).

Methods:

This prospective, multicentre, randomised, parallel-group, assessor- and patient-masked study assessed 156 and 120 patients undergoing cataract surgery targeting emmetropia, with bilateral implantation of DFT015 and SN60WF, respectively. At Month 6 postoperatively, a spectacle use questionnaire was implemented to ask patients the following questions: How often do you wear eyeglasses for: Any purpose? (Question 1); Near tasks (e.g. reading print)? (Q2); Intermediate tasks (e.g. computer)? (Q3); and Distance tasks (e.g. driving)? (Q4). The key effectiveness objective was to demonstrate superiority for DFT015 versus SN60WF in the proportion of patients ‘never’ requiring glasses for ‘Any purpose’ (Q1) and for ‘Intermediate tasks’ (Q3).

Results:

A greater number of patients in the DFT015 group compared with the SN60WF group reported ‘never’ requiring spectacles for ‘Any purpose’ (Q1, 30.2% and 10.0%, respectively) and ‘Intermediate tasks’ (Q3, 75.5% and 53.8%, respectively). The observed 95% lower confidence limit (Q1, 8.77%; Q3, 7.92%) for the difference in proportions between the two groups was greater than the reference value of 0%. DFT015 also demonstrated increased spectacle independence for ‘Near tasks’ (Q2) compared with SN60WF (29.2% and 8.8%, respectively). Both DFT015 and SN60WF groups demonstrated similar, high frequencies of patients reporting ‘never’ requiring spectacles for ‘Distance tasks’ (Q4, 91.5% and 90.0%, respectively).

Conclusions:

This large study demonstrates that the non-diffractive presbyopia-correcting IOL DFT015 provides an increased number of patients with spectacle independence compared with the aspheric monofocal control. When targeting emmetropia with DFT015, surgeons should set expectations that patients will likely need spectacles for some of their near tasks.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented