Clinical Results Of Trifocal Toric Intraocular Lenses For Lower Astigmatisms In Japanese Eyes

To achieve better clinical outcomes with multifocal intraocular lenses (IOLs), reducing the preexisting corneal astigmatism is mandatory. The AcrySof IQ PanOptix Toric IOL (TFNT30-60: Alcon) is commercially available in Japan; however, the model (TFNT20: cylinder power of 1.00 D) to correct low amounts of astigmatism has not yet been approved. The purpose of this study was to evaluate the effectiveness and safety of the TFNT20 when implanted to replace the natural lens following cataract removal. The study was funded by Alcon for the approval in Japan.

This prospective, single-center, non-comparative study included 41 eyes of 32 Japanese patients (mean age: 65.2 years) who were eligible to receive TFNT20 in at least one eye based on a new Alcon Toric calculator following cataract removal. The surgery was performed through 2.2 mm temporal corneal incision, and IOL axis was aligned using a digital marker. The primary effectiveness endpoint was the percentage (%) of eyes with ≤ 0.25 D refractive cylinder power, and secondary endpoints included % of ≤ 0.50 D refractive cylinder and mean refractive cylinder at 30-60 days post-op. Safety endpoints included adverse events. In addition, uncorrected monocular visual acuities (VAs) at 5m, 60cm, and 40 cm, and IOL misalignment were evaluated.

The residual refractive cylinder of ≤ 0.25 D was achieved in 90.2% of eyes, that of ≤ 0.50 D in 100% of eyes, and average refractive cylinder was 0.055±0.153 D. Six ocular adverse events in 5 patients were reported, however, none were device related. No secondary surgical interventions or posterior capsulotomies were reported. Mean logMAR VAs were: -0.088±0.088 (5 m), -0.001±0.071 (60 cm), and 0.031±0.068 (40 cm). The average IOL misalignment was 3.8±3.5 degrees at 30-60 days post-op. 

Trifocal Toric IOL with low cylinder power was effective and safe when implanted in Japanese eyes with low preexisting corneal astigmatism.