Pilot Evaluation of the Outcomes After Cataract Surgery with Implantation of a New Diffractive Trifocal Intraocular...

To assess the clinical performance and patient-reported outcomes of a new trifocal intraocular lens (IOL) over a 6-month follow-up period.

Prospective, non-comparative, single-center study including 20 eyes (10 patients, age, 47-79 years) undergoing bilateral cataract surgery with implantation of the trifocal diffractive IOL AT ELANA 841 P (Carl Zeiss Meditec, Jena, Germany). Visual acuity (VA) and refraction changes were evaluated over a 6-month follow-up period. Likewise, other clinical and patient reported outcomes were analyzed: binocular defocus curve (1 month), patient satisfaction and vision-related difficulties (Catquest 9SF, 3 months), photopic and mesopic contrast sensitivity (CS) and photic phenomena (6 months).

The 6-month postoperative spherical equivalent was within ±1.00 and ±0.50 D in 100% and 85% of cases, respectively. Mean binocular 6-month postoperative uncorrected distance, intermediate and near VA of -0.12 ± 0.06, -0.02 ± 0.06 and 0.06 ± 0.09 logMAR, respectively. Mean binocular 6-month postoperative distance-corrected intermediate and near VA were 0.00 ± 0.05 and 0.04 ± 0.08 logMAR. VA in the defocus curve remained ≤0.10 logMAR across defocus levels ranging from +0.50 D to -3.00 D. All CS values fell within the normal range, except for the 18 cycles/° spatial frequency measured under mesopic conditions with glare. Postoperatively, 90% of patients reported no vision-related difficulties in daily life and all patients reported being "very satisfied" postoperatively. A web-based simulator confirmed that photic phenomena were minimally disruptive postoperatively.

The trifocal IOL evaluated provides preliminarily a successful distance, intermediate and near visual rehabilitation, with high levels of patient satisfaction and visual quality associated.