Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design

Launched by AST PRODUCTS, INC. · Sep 20, 2023

Keywords

ClinConnect Summary

This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
• • Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.
• Exclusion Criteria:
• • Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
• • Previous corneal surgery.
• • Rubella or surgery due to traumatic cataract.
• • Ocular trauma or refractive surgery.
• • Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study