Assessment Of The Cristalens Paired Artis Symbiose Toric Intraocular Lens: Preliminary Results

The purpose of this clinical investigation is to study the performance and safety of the Cristalens multifocal ARTIS SYMBIOSE toric intraocular lenses (IOLs), designed to offer a continuous sharp vision from 40 to 90 cm thanks to the MID and PLUS complementarity. The tested hypothesis is a rotation stability of ARTIS T PL E and toric version of ARTIS SYMBIOSE, defined by a rotation ≤ 5 degrees at 6-months post-operative follow-up.

Oftalvist, Jerez de la Frontera, Spain

40 age-related cataract patients, age between 50 and 85 years old, with corneal astigmatism needing a cylinder correction between 0.75 to 3.75D at the IOL plane will be included in the study. 20 patients will be implanted with the ARTIS T PL E IOL and 20 patients with the ARTIS SYMBIOSE T IOL. This single-center prospective study was approved by the Ethics Committee of the Hospital Clínico San Carlos (Madrid, Spain) and was conducted in accordance with the tenets of the Declaration of Helsinki. Main outcome measures were rotational stability, refractive error and monocular corrected distance visual acuity (CDVA) and monocular uncorrected distance visual acuity (UDVA) values. Intra- and post-operative complications were recorded.

IOL power was calculated using the on-line Cristalens Toric Calculator medical device. Assessment of the IOL stability (rotation/decentration) in artificial mydriasis by using photographs of retroillumination pictures were analyzed by comparing the position of the IOL at the 1-2 days postoperative visit to the surgical intended position. The preliminary outcomes with 10 eyes implanted with the ARTIS SYMBIOSE T IOL revealed a mean rotation of 0.83±2.88 degrees (ranging from 0 to 10 degrees). Mean intraocular pressure was 14.9±2.69 mmHg (ranging from 13 to 21 mmHg). No intra- and post-operative complications were recorded.

Our preliminary study shows that the ARTIS SYMBIOSE T IOL provides good rotational stability after its implantation without intra- and post-operative adverse events. The study is still ongoing, additional data are expected in the coming months to confirm these promising results