A randomised controlled multi-center clinical investigation of the performance of the next generation design of an intraocular lens that provides an extended range-of-vision

Session Details

Session Title: Extended Depth-of-Focus IOL Concepts

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 09:18

Venue: Room A4

First Author: : T.Clinch USA

Co Author(s): :    E. Thomas   C. Garufis                 

Abstract Details

Purpose:

This was a comparative clinical investigation of a new intraocular lens with a diffractive optic profile designed to provide clear vision through the full range of far, intermediate, and near distances.

Setting:

Twelve private surgical clinics across the USA. Study investigators: Kerry Assil MD, Daniel Chang MD, William Christie MD, Thomas Clinch MD, Joseph Gira MD, Jerry Hu MD, Jason Jones MD, James Loden MD, Maria Scott MD, Vance Thompson MD, David Vroman MD, Jeffrey Whitman MD.

Methods:

After giving written consent, seventy-seven subjects were enrolled and bilaterally implanted with the new intraocular lens Model ZHR00 (test) and 79 subjects were bilaterally implanted with the TECNIS Symfony Extended Range of Vision Intraocular Lens Model ZXR00 (control). Postoperative evaluations that included visual acuity, defocus and contrast sensitivity testing were scheduled at 1 month and 6 months.

Results:

Test eyes achieved better distance corrected near visual acuity (40 cm) compared to control eyes (p<0,0001) without compromising distance or intermediate (66 cm) acuities, mesopic contrast sensitivity or visual symptoms. There was a 1,4 line-difference in mean monocular distance-corrected acuity between groups at near, with no more than a 0,5-line difference between groups at distance and intermediate. Defocus test results demonstrated a mean increase in mean monocular depth of focus at 0,2 LogMAR by about 0,5 D more for test eyes than control eyes. The rates of adverse events and reported visual symptoms were similar between the two groups.

Conclusions:

The new extended range of vision intraocular lens Model ZHR00 has been shown to provide a significant improvement in near visual performance compared to the TECNIS Symfony Intraocular Lens Model ZXR00. With otherwise comparable performance at distance and intermediate, as well as a similar safety profile as indicated by adverse event and visual symptom rates, the new Model ZHR00 lens provides a more extended range of vision than the Model ZXR00 lens.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation