Posters

Clinical investigation of an intraocular lens designed to provide an improvement in intermediate vision when compared to an aspheric monofocal intraocular lens control

Poster Details

First Author: J.Domingo USA

Co Author(s): A. Alarcon   B. Jackson   G. Auffarth   D. Janakiraman           

Abstract Details

Purpose:

To compare the clinical performance of an 1-piece intraocular lens (IOL), Model ICB00, with an aspheric monofocal IOL control, TECNIS 1-piece Model ZCB00. Model ICB00, was designed to have the added benefits of an extended depth of focus and intermediate vision, while maintaining distance vision and a dysphotopsia profile when compared to a monofocal IOL.

Setting:

Prospective, two-phased, 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 Model ICB00 and 72 subjects implanted with Model ZCB00 were available for the 6-month visit.

Methods:

Investigators used his or her standard, small-incision, phacoemulsification cataract extraction surgical technique to implant the IOLs in the capsular bag. Monocular and 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 acuity chart at 4 m for distance and 66 cm for intermediate. Patients were also self-administered the validated Patient Reported Visual Symptoms Questionnaire (PRVSQ) at the beginning of each visit.

Results:

The mean monocular and binocular BCDVA for Model ICB00 was noninferior to Model ZCB00; the difference of 0.045 LogMAR and -0.043 LogMAR, respectively, was within 0.1 LogMAR. The mean monocular and binocular DCIVA for Model ICB00 provided a statistically significant improvement compared to Model ZCB00; the difference of 1.1 lines for both (p<0.0001). The mean monocular and binocular UCIVA for Model ICB00 provided a statistically significant improvement compared to Model ZCB00; the difference of 1.1 lines and 1.0 line, respectively (p<0.0001). There were no statistically significant differences in visual symptoms for the IOLs. Serious Adverse Events rates were also comparable.

Conclusions:

The 6-month results of the clinical investigation confirmed the intended performance of the Model ICB00. These results also demonstrated reasonable assurance of the safety and effectiveness of the Model ICB00.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented