Prospective Multicenter Clinical Trial With The Precizon Presbyopic Toric Multifocal Intraocular Lens
Published 2023 - 41st Congress of the ESCRS
Reference: PP13.05 | Type: Free paper | DOI: 10.82333/y2ha-j431
Authors: Ronald Steven II Seno Medalle* 1 , Antonio Martínez Abad 2 , Alejandra Eliana Rodriguez 2 , M.P. Holzer 3 , Youngsub Eom 4 , Javier Mendicute del Barrio 5 , Jorge Alió 6 , Mario Canto Cerdan 7
1Medical Staff Department,Associated Cebu Eye Specialists,Cebu,Philippines;Ophthalmology Department,Cebu Velez General Hospital,Cebu,Philippines;Research, Development and Innovation Department,Vissum Grupo Miranza,Alicante,Spain, 2Research, Development and Innovation Department,Vissum Grupo Miranza,Alicante,Spain, 3Augenzentrum Prof. Dr. Holzer & Prof. Dr. Rabsilber,Weinheim,Germany, 4Ansan Hospital, Ansan,Korea, Republic Of, 5Hospital Universitario Donostia,Donostia-San Sebastián,Spain, 6Department of Cornea and Refractive Surgery,Vissum Grupo Miranza,Alicante,Spain;Universidad Miguel Hernandez,Alicante,Spain, 7Development and Innovation Department,Vissum Grupo Miranza,Alicante,Spain
Purpose
The purpose of this study was to evaluate the visual, refractive, and clinical and optical quality outcomes of a new segmented multifocal toric intraocular lens (MIOL) (Precizon Presbyopic Toric, OPHTEC BV). The lens is a refractive segmental multifocal toric optic with near vision add for 40cms of +2.75D. It is a monobloc single piece IOL.
Setting
Multicentric interventional prospective consecutive international study in Spain, Germany and South Korea.
Methods
The study is a prospective, open-label, single-arm, multicenter clinical evaluation of 50 eyes of 25 patients (mean age 64.6±8.01 years). Bilateral cataract/clear lens extraction with Precizon Presbyopia Toric IOL implantation was done with followup of 6 months. Postoperative examination included uncorrected (UNVA) and corrected near visual acuity (CNVA), uncorrected (UIVA) and corrected intermediate visual acuity (CIVA), and uncorrected (UDVA) and corrected distance visual acuity (CDVA), refraction and stability in diopters (D), lens stability, contrast sensitivity (CS) and defocus curve, clinical/optical quality thru retinal PSF at different pupil diameters for far vision with pyramidal aberrometry, complications and patient satisfaction.
Results
At 6 months, postoperative outcomes achieved binocular UDVA same or better than CDVA and within 1 line of CDVA in 100% of patients. UNVA of <0.2 logMAR was achieved in 88%. UDVA of <0.2 logMAR occured in of 90%. UIVA of <0.2 logMAR was found in 100%. Spherical equivalent change of >0.50D occured in 10% with intended targets but within ±1.00D in 100%. Postoperative refractive astigmatism of <1.00 were in 93%. Spectacle independence for all distances was accomplished in 96% with high satisfaction. CS values were mostly >1.5 and were similar with or without induced photic phenomena. Defocus curve showed >0.3 logMAR in +1.5 to -3.5. The PSF values were excellent (<0.4). There were no serious complications where <5% needed IOL repositioning.
Conclusions
The Precizon Presbyopic Toric mIOL was shown to be very suitable for the correction of both presbyopia and astigmatism. Excellent near, intermediate and distance visual acuities were achieved with stable refraction shown over the course of the study. There was high satisfaction among patients due to overall spectacle independence, low and well-tolerated subjective photic phenomena and a defocus curve maintaining good vision within most of the range. The resulting higher order aberrations were within normal values, thus achieving good optical and clinical quality of vision. There was surgical misalignment in very few cases, otherwise no serious complications had occured.