Posters

Clinical outcomes following bilateral implantation of a new non-diffractive, presbyopia correcting intraocular lens from two large confirmatory multicountry studies

Poster Details

First Author: A.Mearza UK

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

Abstract Details

Purpose:

To characterize the clinical outcomes following bilateral implantation with a new non-diffractive presbyopia correcting intraocular lens (IOL) AcrySof IQ Vivity (model DFT015) versus an aspheric monofocal IOL (model SN60WF) from two large confirmatory multicountry studies.

Setting:

Post-operative clinical outcomes obtained at 6-months from a combined 30 global investigational sites located in Australia (3), Canada (6), Spain (6), UK (4) and USA (11).

Methods:

These prospective, multi-center, randomized, parallel group, assessor and patient masked studies included (study 1, OUS) 273 bilaterally implanted patients, of whom 268 completed the study (DFT015, n=151; SN60WF, n=117) and (study 2, US) 219 bilaterally implanted patients, of whom 217 completed the study (DFT015, n=106; SN60WF, n=111). Binocular best-corrected distance visual acuity (BCDVA; 4 m), distance-corrected intermediate visual acuity (DCIVA; 66 cm), and distance-corrected near visual acuity (DCNVA; 40 cm) were assessed at Month 6. Defocus curve and quality of vision (QoV study 1; QUIVID) study 2 were also assessed.

Results:

Distance VA was similar between the groups (mean binocular BCDVA < 0.0 logMAR) while the observed means for binocular DCIVA indicated an improvement of > 1-line with DFT015. The observed means for binocular DCNVA indicated ~1-line improvement (OUS), and greater than 1-line improvement (US) favoring DFT015. DFT015 demonstrated a > 0.5 D extended mean binocular defocus range over SN60WF at 0.2 logMAR. The OUS rates of reporting not at all severe glare, halos, or starbursts were similar (<10% difference) between groups. Rates of US patients reporting “not at all bothered” by starbursts, halos, and glare were similar (<10% difference) between groups.

Conclusions:

In comparison with an aspheric monofocal IOL, these two large-scale, independent confirmatory trials indicate that the DFT105 non-diffractive presbyopia correcting IOL improves near and intermediate vision without reducing distance vision. Patients bilaterally implanted with the DFT105 IOL reported low rates of visual disturbances comparable to an aspheric monofocal.

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 competing company, 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