Abstract
PURPOSE: To determine the postoperative visual performance of patients after bilateral implantation of a new trifocal aspheric hydrophobic intraocular lens (IOL) following cataract or refractive lens exchange surgery. METHODS: This was a prospective, multicentric, open-label clinical study. Patients were implanted bilaterally with the AT ELANA 841P IOL targeted for emmetropia. One and 3 months postoperatively, subjective refraction, binocular uncorrected and distance-corrected visual acuities for far (UDVA, CDVA), intermediate (UIVA, DCIVA), and near (UNVA, DCNVA) distances, monocular and binocular defocus curves, binocular photopic and mesopic contrast sensitivity, patient satisfaction in terms of visual disturbance, and spectacle independence were recorded. RESULTS: A total of 58 patients were evaluated. Three months postoperatively, the average postoperative spherical equivalent was 0.20±0.39D and 83.3% and 95.8% of eyes were within ±0.50D and ±1.00D, respectively. 88.5% of eyes showed refractive cylinder values of ≤0.50D, and 97.9% had values of ≤1.00D. For distance vision, 98% of patients had CDVA of 0 logMAR or better; for intermediate vision, 90% and 92% of patients had DCIVA of 0.10 logMAR or better at 80 and 66 cm, respectively; and for near vision 65% and 77% of patients presented DCNVA of 0.10 logMAR or better at 40 cm and preferred distance, respectively. The depth-of-focus from 0D was about 3.0D. The contrast sensitivity curves showed standard patterns under photopic and mesopic conditions. Questionnaires revealed that 87.2% of patients were either completely, very, or somewhat satisfied with their vision. A high spectacle independence rate of 85.1% was reported, while for visual symptoms, high percentages (59.6% to 100%) reported having them never or sometimes. CONCLUSION: The AT ELANA 841P trifocal aspheric hydrophobic IOL provides excellent accurate refractive outcomes with very good visual performance across multiple distances, resulting in high spectacle independence rate and satisfaction levels with minimal visual symptoms.