RESUMO
PURPOSE: To evaluate the safety and effectiveness of bilateral refractive lens exchange (RLE) with trifocal intraocular lens (IOL) as the surgical treatment of presbyopia. SETTINGS: Memira AS. Norway, Sweden and Denmark. DESIGN: Multicentric retrospective interventional case series. METHODS: 17 603 consecutive patients submitted to bilateral presbyopic RLE with trifocal IOLs from 2013 to 2019. The main outcomes were manifest refraction spherical equivalent (MRSE), uncorrected distance (UDVA) and near (UNVA) visual acuity, corrected distance visual acuity (CDVA), vision gain/loss, safety and efficacy indices, IOL power calculation accuracy and rate of excimer laser enhancements. RESULTS: Three months postoperatively, the mean MRSE was 0.00±0.40 diopters (D), mean binocular UDVA was -0.03±0.09, with 14 470 patients (82.2%) with combined binocular UDVA and UNVA equal or better than 0.00 and Jaeger 3. Approximately 86% (n=30.124) of the eyes were within 0.50D of MRSE. Enhancement surgery was performed in 5810 eyes (16.5%). IOL power calculation refining improved accuracy and reduced enhancements rate from 20% in 2013 to 12% in 2019. Safety and efficacy indices were 0.98±0.11 and 0.85±0.18, respectively. Myopic eyes presented significant higher safety (1.00±0.19) and efficacy indices (0.87±0.19), with p<0.005. Approximately 0.38% (n=130) of the eyes lost two or more lines of CDVA, with cystoid macular oedema (n=53, 40.8%) and posterior capsular opacification (n=35, 26.9%) as the main causes. After proper care, the final incidence of two or more lines of vision loss was 0.08% (28 eyes). CONCLUSIONS: Presbyopic RLE with trifocal IOL is a safe and effective modality of treatment for patients with presbyopia.