Defocus Curve Performance And Near Activity Visual Questionnaire Outcomes Following Bilateral Implantation Of A Novel Full Range Of Vision Trifocal Iol Among Cataract Patients.

To evaluate the defocus curve performance and near activity visual questionnaire outcomes following bilateral implantation of either a trifocal or a monofocal intraocular lens (IOL) in subjects scheduled to undergo cataract surgery. 

Nine Canadian sites. 

In this prospective multicenter study, 160 cataract patients were randomized in a 2:1 ratio to receive bilateral implantation of either the full visual range enVista trifocal (N = 110) or enVista monofocal IOL (N = 50). Outcome measures included postoperative (120-180 days after surgery) uncorrected intermediate (UIVA) and near visual acuity (UNVA), spectacle independence, and patient-reported ability to do near-vision tasks. A validated near-activity visual questionnaire (NAVQ) was used to evaluate patient experience with near-vision tasks. Binocular defocus curves were assessed under photopic conditions from +1.50 D to -3.50 D after second eye IOL implantation.

A higher proportion of patients implanted with a full visual range trifocal IOL could perform near vision-related tasks with no or little difficulty while being spectacle-free than those with monofocal IOL (90% vs 50%, p <0.0001). Nearly 91 to 95% of the patients could see the display & keyboard on a computer or mobile phone, and 88% of the patients were able to read small print with no or little difficulty. Binocular defocus curve comparison showed that both groups had similar peaks at 0.0 D, achieving mean visual acuity of better than 0 logMAR. In the intermediate and near vision range (-1.00 to -2.50 D), the trifocal group demonstrated a plateau at ~0.1 logMAR, whereas the monofocal group decreased from ~0.16 to 0.48 logMAR. 

NAVQ outcomes showed that a statistically significantly higher proportion of enVista trifocal IOL patients (93% vs 56%, p <0.0001) were satisfied with their postoperative near vision. More than 90% of the enVista trifocal IOL implanted patients could perform various near-vision-related daily activities with little or no difficulty while being spectacle-free. The trifocal group exhibited a higher binocular depth of focus than the monofocal group. In the intermediate to near range (-1.00 to -2.50 D defocus), the trifocal IOL exhibited a 2- to 4-line better visual acuity than the monofocal IOL.