Menu
Enrolling by invitation NCT06056154

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

— Observational Cataract Pseudophakia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LIO ASQELIO TM monofocal QLIO130C.
Who it may be relevant to
Registry conditions: Cataract, Pseudophakia. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device LIO ASQELIO TM monofocal QLIO130C
    Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

Primary outcome measures

  • Incidence of Posterior capsular opacity [Time frame: 24 months after IOL implantation]
  • Intensity of Posterior capsular opacity [Time frame: 24 months after IOL implantation]
  • Visual acuity [Time frame: At least 24 months after IOL implantation]
Secondary outcome measures (3)
  • Refraction [Time frame: At least 24 months after IOL implantation]
  • Incidence of Glistening [Time frame: At least 24 months after IOL implantation]
  • Intensity of Glistening [Time frame: 24 months after IOL implantation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Spain · 1 center
  • Oftalmología Vistahermosa SL — Alicante

Identifiers

NCT: NCT06056154 · ASQM012023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗