NCT04971863

In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens. Two-year Follow-up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: AST Products, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.

Detailed description

This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.

Conditions

• Cataract
• Intraocular Lens Complication

Timeline

• Start date: 2022-03-30
• Primary completion: 2023-10-31
• Completion: 2024-01-05
• First posted: 2021-07-22
• Last updated: 2024-01-31

Locations

1 site across 1 country: Spain