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OpenTrials
Enrolling by Invitation

NCT Number: NCT06056154

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Pathological Conditions, Signs and Symptoms Pseudophakia Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oftalmología Vistahermosa SL

Alicante, 46026, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIO ASQELIO TM monofocal QLIO130C

Device

Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

Primary outcomes

  1. Incidence of Posterior capsular opacity

    Time frame: 24 months after IOL implantation

    Incidence of PCO

  2. Intensity of Posterior capsular opacity

    Time frame: 24 months after IOL implantation

    Intensity of PCO determined using LOCSIII Classification

  3. Visual acuity

    Time frame: At least 24 months after IOL implantation

    Best corrected distance visual acuity in LogMAR units using the ETDRS chart

Secondary outcomes

  1. Refraction

    Time frame: At least 24 months after IOL implantation

    Residual refractive error in diopters determined objectively

  2. Incidence of Glistening

    Time frame: At least 24 months after IOL implantation

    Incidence of IOL glistening

  3. Intensity of Glistening

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AST Products, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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