Patient-Reported Outcomes After Keratorefractive Lenticule Extraction Using the VISUMAX 800 Laser in a Prospective...

Area of Science:

• Ophthalmology
• Refractive Surgery
• Biomedical Engineering

Background:

• Refractive errors like myopia and astigmatism affect millions globally.
• Surgical interventions aim to correct vision and reduce dependence on corrective lenses.
• Femtosecond laser lenticule extraction offers a minimally invasive approach to vision correction.

Purpose of the Study:

• To evaluate patient-reported outcomes (PROs) following lenticule extraction using the VISUMAX 800 femtosecond laser.
• To assess patient satisfaction, spectacle dependence, visual symptoms, and quality of life post-procedure.
• To gather post-market clinical follow-up data on the VISUMAX 800 system's performance.

Main Methods:

• A prospective, non-randomized, multicenter, international post-market clinical follow-up study.
• 226 patients with myopia and astigmatism underwent bilateral lenticule extraction with the VISUMAX 800.
• Patient-reported outcome questionnaires, adapted from the PROWL, were administered preoperatively and at 6-month follow-up.

Main Results:

• 98.7% of patients reported being satisfied with the lenticule extraction results.
• 93.8% achieved independence from glasses or contact lenses for distance and near vision.
• 80.5% experienced minimal difficulty driving at night; 98.2% would undergo the procedure again.

Conclusions:

• Lenticule extraction using the VISUMAX 800 femtosecond laser yields excellent patient-reported outcomes.
• High patient satisfaction and significant glasses independence were observed.
• The procedure demonstrated a low incidence of severe visual disturbances, supporting its efficacy and safety.