Patient-Reported Outcomes After Keratorefractive Lenticule Extraction Using the VISUMAX 800 Laser in a Prospective Multicenter Post-market Clinical Follow-up Study.

PURPOSE: To investigate patient-reported outcomes following lenticule extraction using the VISUMAX 800 laser (Carl Zeiss Meditec AG) as part of a post-market clinical follow-up (PMCF) study.

METHODS

This prospective, non-randomized, multicenter, international PMCF study was conducted from July 2021 to March 2023. Patients with myopia up to -10.00 diopters (D) and astigmatism up to 5.00 D underwent lenticule extraction using a VISUMAX 800 femtosecond laser. Patients completed an electronic patient-reported outcome questionnaire preoperatively and at the 6-month follow-up visit. The questionnaire was adapted from the U.S. Food and Drug Administration Patient-Reported Outcomes with LASIK (PROWL) questionnaire, which evaluates patient satisfaction, spectacle dependence, visual symptoms, and vision-related quality of life.

RESULTS

A total of 226 patients completed a 6-month follow-up after bilateral treatment, of which 98.7% were "completely," "very," or "somewhat" satisfied with the results, 98.2% were satisfied with visual recovery time, 93.8% no longer required glasses or contact lenses for distance and near activities, and 80.5% had little or no difficulty when driving at night. Overall, 99.1% were happy they had lenticule extraction with the VISUMAX 800, 98.2% would choose the procedure again, and 98.7% would recommend the procedure to others. Four patients would not repeat the procedure (3 due to dissatisfaction with results, 1 despite being satisfied with their outcome), whereas 3 patients would not recommend it (2 due to dissatisfaction with results, 1 despite being satisfied).

CONCLUSIONS

Lenticule extraction performed with the VISUMAX 800 demonstrated excellent patient-reported outcomes with a high level of patient satisfaction and glasses independence with few reports of severe visual disturbances.