Prospective Randomized Multicenter Comparison of the Clinical Outcomes of V4c and V5 Implantable Collamer Lenses: A Contralateral Eye Study

PURPOSE: To compare the visual and refractive outcomes and night vision performance questionnaire results between V4c and V5 implantable Collamer lenses in a prospective, randomized, multicenter study. SETTINGS: Four refractive surgery centers. DESIGN: Prospective randomized multicenter single-masked comparative study. METHODS: Twenty-three patients were enrolled in this study. A conventional V4c model (EVO Visian ICL) was implanted in one eye, and a V5 model (EVO+ Visian ICL), which has a larger optic diameter than the V4c model, was implanted in the contralateral eye. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were evaluated before and 6 months after surgery. At 6 months after surgery, a questionnaire on night vision disturbances was administered. The efficacy, safety, and predictability of the two implanted ICL models were compared. RESULTS: There were no significant differences in the postoperative UDVA and CDVA between the two ICL models. The mean efficacy indexes for the V4c and V5 lenses were 1.16 ± 0.22 and 1.03 ± 0.23, respectively. The mean safety indexes of the V4c and V5 lenses were 1.21 ± 0.20 and 1.19 ± 0.20, respectively. The night vision performance questionnaire revealed that 7 patients (37%) noticed a difference in visual performance between the eyes, and all of them reported that they could see better at night with the V5-implanted eye compared with the V4c-implanted eye. CONCLUSION: The V4c and V5 ICL models achieved similar visual and refractive outcomes, whereas the V5 model showed a possible advantage in reducing night vision disturbances.