Kata Miháltz1,2, Pia Veronika Vécsei-Marlovits3,4. 1. Department of Ophthalmology, Hospital Hietzing, Wolkersbergenstrasse 1, 1130, Vienna, Austria. kata.mihaltz@wienkav.at. 2. Karl Landsteiner Institute of Process Optimization and QM in Cataract Surgery, Vienna, Austria. kata.mihaltz@wienkav.at. 3. Department of Ophthalmology, Hospital Hietzing, Wolkersbergenstrasse 1, 1130, Vienna, Austria. 4. Karl Landsteiner Institute of Process Optimization and QM in Cataract Surgery, Vienna, Austria.
Abstract
PURPOSE: To evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL. METHODS: In this prospective, randomized comparative study, 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration-correcting diffractive, bifocal Tecnis ZLB00 IOLand 60 eyes of 30 age-matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation procedure was performed 1, 3, and 6 months postoperatively. Main outcome measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations, and visual quality metrics with 2 mm and 4 mm pupil and the position of visual axis. RESULTS: At the 6-month visit, no significant difference was found in monocular and binocular uncorrected (UDVA) and corrected (CDVA) distance and near (UNVA, CNVA) visual acuity between the groups. Spherical and coma-like aberrations were similar measured with a 2-mm pupil, but with a 4-mm pupil, the SA was significantly larger (in negative direction) in the Diffractiva group. The higher-order Strehl ratio and MTF was significantly larger in the Diffractiva group measured at 2 mm entrance pupil; however, this difference disappeared by the 4-mm pupil measurements. Postoperative angle alpha distance had a significant influence on HO Strehl value. CONCLUSIONS: The size of angle alpha is a predictive factor of image quality by multifocal IOL patients. TRIAL REGISTRATION: Trial registration number and date of registration: NCT04274088, 14.02.2020.
RCT Entities:
PURPOSE: To evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL. METHODS: In this prospective, randomized comparative study, 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration-correcting diffractive, bifocal Tecnis ZLB00 IOL and 60 eyes of 30 age-matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation procedure was performed 1, 3, and 6 months postoperatively. Main outcome measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations, and visual quality metrics with 2 mm and 4 mm pupil and the position of visual axis. RESULTS: At the 6-month visit, no significant difference was found in monocular and binocular uncorrected (UDVA) and corrected (CDVA) distance and near (UNVA, CNVA) visual acuity between the groups. Spherical and coma-like aberrations were similar measured with a 2-mm pupil, but with a 4-mm pupil, the SA was significantly larger (in negative direction) in the Diffractiva group. The higher-order Strehl ratio and MTF was significantly larger in the Diffractiva group measured at 2 mm entrance pupil; however, this difference disappeared by the 4-mm pupil measurements. Postoperative angle alpha distance had a significant influence on HO Strehl value. CONCLUSIONS: The size of angle alpha is a predictive factor of image quality by multifocal IOL patients. TRIAL REGISTRATION: Trial registration number and date of registration: NCT04274088, 14.02.2020.