Early results of trifocal IOL exhibit solid performance

August 25, 2017

Researchers conducted a 6-month study of patients implanted with the AcrySof IQ PanOptix presbyopia-correcting IOL to determine the binocular defocus curve of the lens. They concluded that these early results show good visual performance across the whole range of defocus. No unexpected adverse events were reported

Reviewed by Thomas Kohnen, MD, PhD

Take-home: Researchers conducted a 6-month study of patients implanted with the AcrySof IQ PanOptix presbyopia-correcting IOL to determine the binocular defocus curve of the lens. They concluded that these early results show good visual performance across the whole range of defocus. No unexpected adverse events were reported

Monofocal intraocular lenses (IOLs) provide optimal vision at a single distance but do not accommodate well for other distances. Multifocal IOLs provide patients with vision over a range of distances. However, there have been limited improvements for intermediate vision.

The AcrySof IQ PanOptix IOL is an aspheric hydrophobic IOL with a blue filter. A 6.0-mm optical zone is composed of a 4.5-mm large diffractive area with 15 diffractive zones and an outer refractive rim. (Images provided by Thomas Kohnen, MD, PhD)

A novel trifocal lens, the AcrySof IQ PanOptix presbyopia-correcting IOL (Alcon Laboratories), attempts to address this deficit by creating an additional focal point for intermediate vision. The multifocal diffractive structure divides incoming light to create intermediate and near add powers of +2.17 D and +3.25 D, respectively.

Prof. Thomas Kohnen, MD, PhD, Goethe University, Frankfurt, Germany, and colleagues presented the results of a study to determine the binocular defocus curve of the AcrySof IQ PanOptix IOL at 6 months post-implantation. The prospective, single arm, non-randomized, multicenter study involved bilateral implantation of the IOL in 151 patients over 21 years of age with bilateral cataracts surgically removed by phacoemulsification.

Study methods/results

The mean binocular defocus curve was obtained at 6 months, and the binocular defocus testing was performed under photopic conditions (~85 cd/m2) using a 100% ETDRS chart at 4 m. Patients were defocused from manifest refraction using a -5 D and +2 D spherical correction. Minus or plus power was decreased in 0.5-D increments until only the best distance correction remained (0.0 D defocus). Visual acuity was recorded in logMAR, and adverse events were summarized descriptively.

A total of 143 patients (38% male, 62% female) with a mean age of 68.9 ± 9.3 years were implanted bilaterally with the PanOptix IOL and had their binocular defocus curve assessed at 6-months post-op. A total of 149 patients received implants but 4 patients were discontinued from the study (3 because of death and 1 to an adverse event), and 2 were unable to attend a study visit before database lock.

Patients who received the IOL achieved a mean visual acuity of 20/25 or better from +0.50 D to -2.50 D. The mean defocus curve visual acuity from 0 D to -3 D ranged from 0.1 to 0.0 logMAR. Average visual acuity at distance (0 D), intermediate (-1.50 D), and near (-2.50 D) was 0.0 D ± 0.1 D, 0.0 ± 0.1 D and 0.1 D ± 0.1 D, respectively. 

Safety

 

Safety

The most common adverse event was dry eye, which occurred in 13 patients in the first eye (8.7%), and 11 patients in the second eye (7.4%). One patient (0.7%) reported 2 serious adverse events of blurred vision and IOL extraction that were related to the study device.

Visual acuity in logMAR and Snellen equivalent. Data reflect mean and 90% confidence intervals.

The most common, non-serious adverse events related to the PanOptix IOL were halos (first eye, n=4 [2.7%], second eye, n=3 [2.0%]), and glare (first eye, n=2 [1.3%], second eye, n=2 [1.4%]). Seven patients (5%) had non-fatal serious adverse events, and 3 deaths were reported. The causes of death were myocardial infarction, acute myocardial infarction, and multi-organ failure–all unrelated to the study device or the study procedures.

The researchers concluded the early results from this study show good visual performance (visual acuity better or equal to 20/25) of the AcrySof IQ PanOptix IOL across the whole range of defocus. At the 6-month visit, the binocular defocus curve for the IOL demonstrated approximate visual acuity of 20/25 or better from near (40 cm) through intermediate (60 cm) to distance. No unexpected adverse events were reported.

 

Thomas Kohnen, MD, PhD

E: kohnen@em.uni-frankfurt.de

This article was adapted from a presentation that Dr. Kohnen delivered at the 2017 American Society of Cataract and Refractive Surgery meeting. Dr. Kohnen is a consultant and/or receives grants from Alcon Laboratories, Carl Zeiss Meditec, Geuder, Hoya, Johnson & Johnson Vision, Oculentis, Oculus, Optikgeräte, Santen GmbH, Schwind, STAAR Surgical, TearLab Corp., Thea Pharma, Thieme Compliance, and Ziemer Ophthalmology.