In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

Completed

• Conditions: Intraocular Lens Complication; Cataract

• Registration Number: NCT04971863
• Lead Sponsor: AST Products, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-22
• Study Start: 2022-03-30
• Status Verified: 2023-02
• Primary Completion: 2023-10-31
• Study Completion: 2024-01-05
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 System

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario y Politécnico la Fe; 🇪🇸 Valencia, Spain