Status:
UNKNOWN
Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.
Lead Sponsor:
AST Products, Inc.
Conditions:
Cataract
Eligibility:
All Genders
22+ years
Brief Summary
The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens ...
Detailed Description
In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior ...
Eligibility Criteria
Inclusion
- Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with LIO ASQELIO.
- Subjects for whom postoperative emmetropia was planned (±0.5 D spherical equivalent)
Exclusion
- Preoperative corneal astigmatism less than 0.75D
- Patients who do not provide informed consent
- Patients who do not understand the study procedure.
- Previous corneal surgery or trauma.
- Irregular cornea (e.g. keratoconus).
- Microphthalmos.
- Severe corneal dystrophy.
- Pregnant or breastfeeding'.
- Rubella
- Mature/dense cataract making eye bottom preoperative examination difficult.
- Previous retinal detachment.
- Concurrent participation in other research with drugs or clinical devices.
- Expect to require another eye surgery during the study period.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06101472
Start Date
February 1 2024
End Date
October 1 2024
Last Update
January 31 2024
Active Locations (3)
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1
Oftalvist Alicante
Alicante, Spain, 03013
2
OftalVist Madrid
Madrid, Spain, 28006
3
OftalVist Valencia
Valencia, Spain, 46004