An observational study in Cataract and Intraocular Lens Complication, sponsored by AST Products, Inc.. Completed at 1 site in Spain. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by AST Products, Inc. · Observational
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 200 is above the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →AST Products, Inc. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult subjects submitted to non-traumatic cataract surgery in at least 1 eye at the Hospital La Fé of Valencia, Spain
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients bilaterally implanted with the Clareon monofocal IOL
Patients bilaterally implanted with the Asqelio monofocal IOL
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
Ran from Mar 2022 to primary completion in Oct 2023, 19 months.
Of 67 industry-sponsored observational studies under Cataract, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 19 months is above that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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AST Products, Inc.