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Completed

NCT Number: NCT04971863

In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario y Politécnico la Fe

Valencia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL

Exclusion criteria

  • Any pathology reducing potential best-corrected visual acuity beyond 0.30 LogMAR, including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, severe recurrent anterior or posterior segment inflammation of unknown ethiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or pseudoexfoliation diagnosis.
  • Previous ocular surgery
  • Rubella
  • Surgery motivated by traumatic cataract
  • Ocular trauma or refractive surgery
  • Any other systemic or ocular condition that, in the investigator's opinion, should exclude the subject from study
  • Requiring additional procedures due to intraoperatory complications, mechanical or surgical interventions for manipulating the pupil, excessive iris movility, significant vitreous loss, significant, anterior chamber hyphema, capsular annular breakage, or any other unrecognized ocular conditions that might compromise IOL positioning, as well as impossibility of locate the IOL in the capsular bag due to surgical complications.

Treatment and study plan

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 System

Secondary outcomes

  1. Visual acuity

    Time frame: 1 month, 6 months, 12 months and 24 months after IOL implantation

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

  2. Refraction

    Time frame: 1 month, 6 months, 12 months and 24 months after IOL implantation

    Residual refractive error in diopters determined objectively

  3. Optical quality

    Time frame: 24 months after IOL implantation

    Higher-order wavefront aberrations determined using a clinical wavefront analyzer

  4. Incidence of Glistening

    Time frame: 24 months after IOL implantation

    Incidence of IOL glistening

  5. Intensity of Glistening

    Time frame: 24 months after IOL implantation

    Intensity of IOL glistening

Sponsors and collaborators

Lead sponsor

AST Products, Inc.

Industry

Collaborators

  • Hospital Universitario La Fe

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 22, 2021
Registry last updated
Jan 31, 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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