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.
Study Type
OBSERVATIONAL
Enrollment
200
Hospital Universitario y Politécnico la Fe
Valencia, Spain
Incidence of Posterior capsular opacity
Incidence of PCO
Time frame: 24 months after IOL implantation
Intensity of Posterior capsular opacity
Intensity of PCO determined using LOCSIII Classification System
Time frame: 24 months after IOL implantation
Visual acuity
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
Refraction
Residual refractive error in diopters determined objectively
Time frame: 1 month, 6 months, 12 months and 24 months after IOL implantation
Optical quality
Higher-order wavefront aberrations determined using a clinical wavefront analyzer
Time frame: 24 months after IOL implantation
Incidence of Glistening
Incidence of IOL glistening
Time frame: 24 months after IOL implantation
Intensity of Glistening
Intensity of IOL glistening
Time frame: 24 months after IOL implantation
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