Innovative trifocal (quadrifocal) presbyopia-correcting IOLs: 1-year outcomes from an international multicenter study

Abstract

Purpose: To evaluate visual acuity (VA) and safety of the new AcrySof IQ PanOptix presbyopia-correcting IOL at 12 months postimplantation.

Setting: Seventeen sites in Europe, Australia, and South America.

Design: Prospective, single-arm, nonmasked, nonrandomized study.

Methods: Of 167 patients enrolled, 149 received study IOLs in both eyes; 145 completed the study. Binocular uncorrected distance VA (UDVA; 4 m), monocular corrected distance VA (CDVA), binocular distance-corrected intermediate VA (DCIVA; 60 cm and 80 cm), binocular uncorrected near VA (UNVA; 40 cm), and binocular defocus curves were evaluated. Safety was assessed by monitoring adverse events (AEs).

Results: Of 149 patients, 92 patients (62%) were women and 139 patients (93%) were white; mean ± SD age was 68.9 ± 9.3 years. At 12 months, mean binocular UDVA was 0.02 ± 0.11 logarithm of the minimum angle of resolution (logMAR); monocular CDVA was 0.01 ± 0.13 logMAR (first eye) and 0.01 ± 0.10 logMAR (second eye); binocular DCIVA was 0.04 ± 0.12 logMAR and 0.08 ± 0.14 logMAR at 60 cm and 80 cm, respectively; and binocular UNVA was 0.07 ± 0.11 logMAR. At 6 months, mean binocular defocus curve VA (0.00 diopter [D] to -3.00 D) ranged from -0.04 to 0.13 logMAR. Binocular VA at distance (0.00 D), intermediate (-1.50 D), and near (-2.50 D) was -0.04 ± 0.11 logMAR, 0.07 ± 0.13 logMAR, and 0.07 ± 0.13 logMAR, respectively. Serious ocular AE rates were 1.4% or less in first and second eyes. Posterior capsulotomy rates were 3.4% (first eye) and 2.7% (second eye).

Conclusions: The study IOL provided good VA outcomes. Defocus curve showed VA of 20/25 Snellen or better from near to intermediate distance. Rates of serious and nonserious AEs were low.

Figure 1.

(A) Study intraocular model TFNT00 IOL image and (B) physical characteristics and dimensions (Ø_T = overall diameter; Ø_B = optic diameter).

Figure 2.

Patient disposition. *Patients passed screening but were not implanted.

Figure 3.

Visual acuity under photopic conditions. Mean binocular visual acuity (A) and cumulative distribution of binocular visual acuity (B) at 12 months in patients who received the study IOL; n = 145. Error bars represent 90% CIs (DCIVA = distance-corrected intermediate visual acuity; logMAR = logarithm of the minimum angle of resolution; UDVA = uncorrected distance visual acuity; UNVA = uncorrected near visual acuity).

Figure 4.

Cumulative distribution of binocular DCNVA at 12 months under mesopic conditions in patients who received the study IOL; n = 144. Error bars represent 90% CIs (DCNVA = distance-corrected near visual acuity; logMAR = logarithm of the minimum angle of resolution).

Figure 5.

Depth of focus. Visual acuity in logMAR and Snellen equivalent at 6 months are shown (best case analysis set). Data reflect mean and 90% CIs (logMAR = logarithm of the minimum angle of resolution).