Status:
COMPLETED
Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens
Lead Sponsor:
AST Products, Inc.
Conditions:
Cataract
Eligibility:
All Genders
50+ years
Brief Summary
The goal of this observational study is to evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cat...
Eligibility Criteria
Inclusion
- Patients 50 years of age or older undergoing cataract surgery by phacoemulsification and binocular IOL implant AsqelioTM Trifocal TFLIO130C
- Independence of use of glasses after surgery.
- IOL power between +5.0D and +34.0D
- Transparent intraocular media except for cataracts in both eyes.
- Potential postoperative visual acuity of 20/25 or better.
Exclusion
- Preoperative corneal astigmatism greater than 1.0D
- 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 uveitis
- Pregnant or nursing
- Rubella
- Mature/dense cataract that makes it difficult to examine the eye fundus preoperatively.
- Previous retinal detachment
- Concurrent participation in other research with drugs or clinical devices
Key Trial Info
Start Date :
September 2 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 14 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06935565
Start Date
September 2 2022
End Date
October 14 2024
Last Update
April 20 2025
Active Locations (1)
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1
Clinica Baviera
Seville, Seville, Spain, 41013