long-term with a trifocal intraocular lens

Conditions: Cataract

Summary: the main aims of this study were to evaluate the patient reported outcomes (pros), safety and efficacy, after 6-year (66 - 78 months) from the binocular implantation of the at lisa tri 839mp. a secondary aim was to evaluate new metrics such as contrast sensitivity defocus curves and light distortion analysis.

retrospective cross-sectional study with two stages: • phone call interview: first stage included patient reported outcomes of visual function, spectacle independence and satisfaction through questionnaires conducted by a phone call in all the patients implanted in our center with at lisa 839mp from march 2014 to june 2015 (n=92) which accomplished inclusion / exclusion criteria and were able to be contacted by phone (n=62). the incidence of nd-yag capsulotomy was retrospectively evaluated through the revision of the medical history, in patients for which capsulotomy was conducted in our center, or a question, for those treated in another center. • study visit: second stage included the consecutive invitation of these phone interviewed patients to a visit in our center for a long-term visual performance assessment up to accomplish the required sample size (n=37). corrected and uncorrected monocular visual acuities were the primary end-points for testing non-inferiority hypothesis in comparison to 12-month follow-up mean results reported in the literature. secondary variables of assessment were contrast sensitivity defocus curve and light distortion analysis.

Eligibility criteria:
inclusion criteria: * phone call interview: * patients of either sex, 45 years of age or older at the time of surgery and less than 80 years of age at the time of the phone call. * patients implanted bilaterally with the at lisa 839mp miol in the capsular bag. * no surgical complications reported in the clinical history that could affect postoperative visual acuity: damage to the capsular bag, intraocular hemorrhage, etc. * operated between 66 months from the first implanted eye and up to 78 months from the surgery of the second eye * patient able to hear, understand and give express consent orally. * study visit: * to have participated in the first stage of the study corresponding to the phone call interview. * irregular astigmatism in either eye measured with corneal tomography (total high-order corneal aberrations at 4 mm \< 0.5 μm). * patient able to read, understand and provide a written informed consent form. * sufficient availability, willingness, skills, and cognitive awareness to comply with follow-up/study procedures and study visits. exclusion criteria: * phone call interview: * any eye disease documented in the patient's clinical history that may potentially cause a loss of visual acuity or diplopia: active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc. * eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens. * study visit: * pco ≥ 2 according to surgeon criteria that produces a loss of cdva ≥ 0.2 logmar * any eye disorder that can potentially cause a loss of visual acuity or diplopia: active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc. * eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens. * use of systemic or ocular medications that may affect vision in the last 6 months. * subjects who participate in any clinical trial or research with drugs or medical devices within 30 days prior to entry into this research and/or during the period of participation in this research.

Keywords: multifocal intraocular lens long-term safety efficacy defocus curve light distortion