Status:
ENROLLING_BY_INVITATION
Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design
Lead Sponsor:
AST Products, Inc.
Conditions:
Cataract
Pseudophakia
Eligibility:
All Genders
22+ years
Brief Summary
The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens...
Detailed Description
This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products,...
Eligibility Criteria
Inclusion
- Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
- Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.
Exclusion
- Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
- Previous corneal surgery.
- Rubella or surgery due to traumatic cataract.
- Ocular trauma or refractive surgery.
- Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study
Key Trial Info
Start Date :
January 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06056154
Start Date
January 17 2024
End Date
July 1 2025
Last Update
October 8 2024
Active Locations (1)
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1
Oftalmología Vistahermosa SL
Alicante, Spain, 46026