Actively Recruiting
Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
Led by AST Products, Inc. · Updated on 2025-08-24
120
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 questions it aims to answer are: * Do different IOL injectors change the size of the corneal incision during surgery? * Do the injectors lead to different rates of complications during or after surgery? Researchers will compare the use of three different IOL injectors: two preloaded models (pioli™ and pioli™ Plus) and one manually loaded model (lioli™), to see if the preloaded systems improve surgical results compared to the manual one. Participants will: * Undergo routine cataract surgery using one of the three injectors, randomly assigned. * Have measurements taken before and after surgery (e.g., vision tests, corneal incision size). * Be monitored for any side effects or complications during and after the procedure.
CONDITIONS
Official Title
Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 cataract (no other significant eye opacities)
You will not qualify if you...
- Preoperative corneal astigmatism greater than 1.0 diopter
- Previous corneal surgery or history of eye trauma
- Irregular cornea such as keratoconus
- Choroidal hemorrhage
- Microphthalmos
- Severe corneal dystrophy
- Uncontrolled or medically controlled glaucoma
- Clinically significant macular changes
- Severe other eye diseases
- Cataract not related to aging
- Severe optic nerve atrophy
- Diabetic retinopathy or proliferative diabetic retinopathy
- Amblyopia
- Extremely shallow anterior chamber
- Severe chronic uveitis
- Pregnant or breastfeeding
- Rubella infection
- Mature or dense cataracts preventing preoperative retinal exam
- History of retinal detachment
- Participation in another drug or medical device clinical study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clínica OftalVist Sevilla
Seville, Sevilla, Spain, 41018
Actively Recruiting
Research Team
A
Adrián Hernández Martínez, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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