In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract, Intraocular Lens Complication

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clareon Monofocal IOL<br>Patients bilaterally implanted with the Clareon monofocal IOL | |
| Asqelio Monofocal IOL<br>Patients bilaterally implanted with the Asqelio monofocal IOL | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posterior capsule opacitication, incidence