Hospital Universitario y Politécnico la Fe
Valencia, Spain
NCT Number: NCT04971863
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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Notify Me22 year and older
All sexes
Observational
Valencia, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 months after IOL implantation
Incidence of PCO
Time frame: 24 months after IOL implantation
Intensity of PCO determined using LOCSIII Classification System
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
Time frame: 1 month, 6 months, 12 months and 24 months after IOL implantation
Residual refractive error in diopters determined objectively
Time frame: 24 months after IOL implantation
Higher-order wavefront aberrations determined using a clinical wavefront analyzer
Time frame: 24 months after IOL implantation
Incidence of IOL glistening
Time frame: 24 months after IOL implantation
Intensity of IOL glistening
AST Products, Inc.
Industry
In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens. Two-year Follow-up
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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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