Posters

Vision quality of an enhanced monofocal intraocular lens compared to an aspheric monofocal intraocular lens in a clinical investigation

Poster Details

First Author: T.Schultz GERMANY

Co Author(s):    B. Jackson   P. Janakiraman   B. Dick              

Abstract Details

Purpose:

To compare the clinical performance of an enhanced monofocal 1-piece intraocular lens (IOL; TECNIS Eyhance IOL Model ICB00), with an aspheric monofocal IOL control (TECNIS 1-piece Model ZCB00).  The Eyhance IOL was designed to have improved intermediate vision, while maintaining distance vision when compared to a monofocal IOL.

Setting:

Prospective, multicenter, bilateral, randomized, subject/ evaluator masked, 6-month clinical trial of 151 enrolled subjects at 9 sites in Germany and Spain.  Of the subjects bilaterally-implanted with the test IOLs, 67 subjects implanted with Eyhance IOL and 72 subjects implanted with ZCB00 IOL were available for the 6-month visit.

Methods:

Manifest refraction was performed with 100% ETDRS charts at 4 meters.  Binocular best corrected distance visual acuity (BCDVA), distance corrected intermediate visual acuity (DCIVA), and uncorrected intermediate visual acuity (UCIVA) were measured under photopic conditions with an ETDRS chart at 4 m for distance and 66 cm for intermediate.  Additionally, binocular BCDVA was measured at 1 month under mesopic conditions (3 ± 0.5 cd/m2) with 10% low-contrast ETDRS charts.  Monocular best corrected distance contrast sensitivity was measured using the M&S system with sine wave grating charts (1.5, 3, 6, 12,18 cpd) under both mesopic and photopic conditions with glare.

Results:

Manifest refraction was similar between the IOLs. The mean binocular BCDVA for the Eyhance IOL (-0.06 LogMAR) was noninferior (within 0.1 LogMAR) to the ZCB00 IOL (-0.10 LogMAR). The mean binocular DCIVA and UCIVA for the Eyhance IOL was statistically significant better compared to the ZCB00 IOL (difference of 1.1 lines (p<0.0001) and 1.0 line (p<0.0001)). The mean binocular BCDVA under mesopic conditions was statistically similar for the Eyhance (0.436 LogMAR) and the ZCB00 IOL (0.432 LogMAR).  There were no statistically significant differences between the Models in mesopic or photopic contrast sensitivity at any of the sine-wave gratings.

Conclusions:

The 6-month results of the clinical investigation confirmed the intended performance of the Eyhance IOL. It provided similar distance vision quality with a significant improvement in intermediate visual acuity.  These results also demonstrated reasonable assurance of the safety and effectiveness of the IOL.

Financial Disclosure:

... gains financially from product or procedure presented, ... travel has been 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, ... is employed by a for-profit company with an interest in the subject of the presentation, ... is employed by a competing company, ... has significant investment interest in a company producing, developing or supplying product or procedure presented