Effect of central hole location in phakic intraocular lenses on visual function under progressive headlight glare sources

Purpose: To analyze the effect of the central hole location in the V4c implantable collamer lens (ICL) on the quality of vision, including progressive headlight glare simulation and quality of life. Setting: IOBA-Eye Institute, Valladolid, Spain. Design: Case series. Methods: The central hole location was determined by slitlamp and dual Scheimpflug imaging for 6 months or more postoperatively. The visual acuity, mesopic contrast sensitivity, halogen glare contrast sensitivity, xenon glare contrast sensitivity, photostress recovery time after glare, de Boer scale, and Quality of Life Impact of Refractive Correction (QIRC) questionnaire results were evaluated. Multiple regression models were used to analyze the effect of the central hole location on parameters using the pupil center and visual axis as references based on Cartesian and polar coordinates. Results: The safety index was 1.13 and the efficacy index, 1.12. Under all testing circumstances, central hole decentration did not affect the visual acuity or contrast sensitivity. With the visual axis as a reference, worse QIRC values were associated with greater upward central hole displacement (P = .03) and a lower polar angle value (P = .008); also, halogen glare discomfort was greater with a higher radius (P = .04). Using the pupil center as a reference, greater nasal central hole decentration was associated with longer xenon glare photostress recovery time (P = .002). Conclusions: Implantation of the ICL with a central hole yielded excellent visual outcomes, even under increasing glare sources, regardless of the hole's location. However, hole decentration might affect patient-perceived quality of life, bothersome halogen glare, and longer xenon glare photostress recovery time. Such complaints after the early postoperative period might be managed with discrete ICL centration if the central hole is decentered upward or nasally.This study was supported in part by the Spanish Ministry of Economy and Competitiveness (Instituto de Salud Carlos III) through Research Projects RETICS RD16/008/0001 (Oftared); EM-P was supported by Junta de Castilla y León and European Social Fund (EDU/1100/2017)

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses

Purpose: To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. Methods: This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Results: Twenty subjects (10 women, 10 men) (mean age, 27.7 ± 5.6 years; range, 20–41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p = 0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p = 0.18). The study MPDS received higher rates in comfort (study: 8.14 ± 1.09, control: 7.94 ± 0.92; p = 0.56) and satisfaction at day 30 (study: 8.63 ± 0.91, control: 8.29 ± 0.80; p = 0.19), however the scores were not significantly different with the control MPDS. Conclusions: The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation