Status:
RECRUITING
Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
Lead Sponsor:
AST Products, Inc.
Conditions:
Cataract
Lens Implantation, Intraocular
Eligibility:
All Genders
40+ years
Brief Summary
The goal of this observational study is to evaluate whether different intraocular lens (IOL) injectors affect surgical outcomes in patients aged 40 and older undergoing cataract surgery. The main ques...
Eligibility Criteria
Inclusion
- Age 40 years or older
- Scheduled for cataract surgery using phacoemulsification technique
- Planned implantation of an Asqelio™ monofocal intraocular lens (IOL)
- Clear intraocular media, except for the presence of cataract (i.e., no other significant ocular opacities)
Exclusion
- Preoperative corneal astigmatism \> 1.0 diopter (D)
- Previous corneal surgery or history of ocular trauma
- Irregular cornea (e.g., keratoconus)
- Choroidal hemorrhage
- Microphthalmos
- Severe corneal dystrophy
- Uncontrolled or medically controlled glaucoma
- Clinically significant macular changes
- Severe concomitant ocular disease
- Cataract not related to aging
- Severe optic nerve atrophy
- Diabetic retinopathy
- Proliferative diabetic retinopathy
- Amblyopia
- Extremely shallow anterior chamber
- Severe chronic uveitis
- Pregnant or breastfeeding
- Rubella
- Mature or dense cataracts that prevent preoperative retinal examination
- History of retinal detachment
- Concurrent participation in another drug or medical device clinical study
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07140029
Start Date
August 1 2025
End Date
December 1 2025
Last Update
August 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clínica OftalVist Sevilla
Seville, Sevilla, Spain, 41018