In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Intraocular Lens Complication

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Hospital Universitario y Politécnico La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects submitted to non-traumatic cataract surgery in at least 1 eye at the Hospital La Fé of Valencia, Spain

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Clareon Monofocal IOL; Patients bilaterally implanted with the Clareon monofocal IOL
Asqelio Monofocal IOL; Patients bilaterally implanted with the Asqelio monofocal IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Posterior capsular opacity	Incidence of PCO	24 months after IOL implantation
Intensity of Posterior capsular opacity	Intensity of PCO determined using LOCSIII Classification System	24 months after IOL implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Best corrected distance visual acuity in LogMAR units using the ETDRS chart	1 month, 6 months, 12 months and 24 months after IOL implantation
Refraction	Residual refractive error in diopters determined objectively	1 month, 6 months, 12 months and 24 months after IOL implantation
Optical quality	Higher-order wavefront aberrations determined using a clinical wavefront analyzer	24 months after IOL implantation
Incidence of Glistening	Incidence of IOL glistening	24 months after IOL implantation
Intensity of Glistening	Intensity of IOL glistening	24 months after IOL implantation

Collaborators and Investigators

• Sponsor: AST Products, Inc.
• Collaborators: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: incidence; posterior capsule opacitication
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ASQM012021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No