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.
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.
Arms and Interventions
|Clareon Monofocal IOL|
Patients bilaterally implanted with the Clareon monofocal IOL
|Asqelio Monofocal IOL|
Patients bilaterally implanted with the Asqelio monofocal IOL
Primary Outcome Measures
- 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
- 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
- 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
- Incidence of Glistening [24 months after IOL implantation]
Incidence of IOL glistening
- Intensity of Glistening [24 months after IOL implantation]
Intensity of IOL glistening
- Subjects 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL
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
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.
Contacts and Locations
|1||Hospital Universitario y Politécnico la Fe||Valencia||Spain|
Sponsors and Collaborators
- AST Products, Inc.
- Hospital Universitario La Fe
Study Documents (Full-Text)None provided.