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

• Conditions: Pseudophakia; Cataract

• Registration Number: NCT06056154
• Lead Sponsor: AST Products, Inc.

Brief Summary

The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Study Start: 2024-01-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity	At least 24 months after IOL implantation	Best corrected distance visual acuity in LogMAR units using the ETDRS chart
Incidence of Posterior capsular opacity	24 months after IOL implantation	Incidence of PCO
Intensity of Posterior capsular opacity	24 months after IOL implantation	Intensity of PCO determined using LOCSIII Classification

Secondary Outcome Measures

Name	Time	Method
Intensity of Glistening	24 months after IOL implantation	Intensity of IOL glistening. It will be evaluated by examining the center of the IOL optical zone with the pupil dilated using a slit lamp. The intensity of glistening will be graded as the number of glistening in the central region according to the following scale: 0 = absent, 1 = traceable (countable vacuoles), 2=moderate (low density of countless vacuoles), and 3=severe (high density of countless vacuoles).
Refraction	At least 24 months after IOL implantation	Residual refractive error in diopters determined objectively
Incidence of Glistening	At least 24 months after IOL implantation	Incidence of IOL glistening

Trial Locations

Locations (1)

Oftalmología Vistahermosa SL; 🇪🇸 Alicante, Spain