Evaluation of Clinical Performance, Efficacy, and Safety of Phakic Toric Posterior Chamber IOL
To assess the predictability, stability, safety and efficacy of the V4c toric Implantable Collamer lens (TICL) model to correct moderate and high astigmatism.
The study included 155 eyes of 93 patients. This study evaluated eyes that had been implanted with a TICL V4c model. Uncorrected (UDVA) and corrected distance visual acuity (CDVA), refraction, TICL vault and adverse effects were evaluated over 12 months.
The mean sphere was -4.75diopters (D) ±4.71 (SD) (range -17.75 to 7.75 D) and the mean cylinder, -2.16±1.29 D (range -1.00 to -8.00). At 12 months, the mean sphere was 0.00 ± 0.00D and the mean cylinder was -0.002 ± 0.02 D (range 0.00 to -0.25 D). For both astigmatism components 100% of eyes were within ±0.25 D of J0 (r2=0.99) and J45 (r2=1). The mean UDVA was 1.07 ± 0.09 and mean CDVA, 1.07 ± 0.09. Sixteen eyes (11%) lost one or more lines of CDVA and 36% of eyes gained 1 line or more. The safety index was 1.05 at 12 months. The efficacy index was 1.04 at one year. There was only one patient with an ICL rotation with a required reposition.
The visual and refractive outcomes were excellent and highly stable throughout the follow-up period. These results suggest that this TICL model is predictable, stable, safe and effective to correct low and high levels of astigmatism.