Status:
COMPLETED
Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens
Lead Sponsor:
AST Products, Inc.
Conditions:
Cataract
Eligibility:
All Genders
50+ years
Brief Summary
The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to ca...
Eligibility Criteria
Inclusion
- Patients submitted to cataract surgery with phacoemulsification with bilateral implantation of Asqelio Trifocal Toric IOL to avoid residual astigmatism
- Patient signing informed consent
- Clear intraocular media, except for cataracts in both eyes prior to surgery
- Monocular potential postoperative visual acuity of 20/25 or better
Exclusion
- Corneal astigmatism lower 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)
- Choroidal hemorrhage
- Microphtalmos
- Severe corneal dystrophy
- Uncontrolled or medically controlled glaucoma
- Clinically significant macular changes
- Concomitant severe eye disease
- Non-age-related cataract
- Severe optic nerve atrophy
- Diabetic retinopathy
- Proliferative diabetic retinopathy
- Amblyopia
- Extremely shallow anterior camera
- Severe chronic uveítis
- Pregnant or nursing
- Rubella
- Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
- 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 :
November 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06190925
Start Date
November 3 2022
End Date
December 12 2023
Last Update
January 8 2024
Active Locations (1)
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1
OftalVist Alicante
Alicante, Spain, 03015