Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
Launched by AST PRODUCTS, INC. · Aug 22, 2025
Trial Information
Current as of September 11, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical study is looking at three different tools used to insert artificial lenses during cataract surgery in adults aged 40 and older. Cataracts cause the eye’s natural lens to become cloudy, and surgery replaces this lens with a clear artificial one. The study compares two preloaded lens injectors (called Pioli™ and Pioli™ Plus) and one that requires manual loading (called Lioli™) to see if the type of injector affects the size of the cut made in the eye or the chances of complications during or after surgery.
If you join this study, you will have routine cataract surgery using one of these three lens injectors, chosen at random. Before and after surgery, doctors will measure things like your vision and the size of the eye incision. They will also watch closely for any side effects or problems. To be eligible, you need to be 40 or older, have cataracts caused by aging, and be scheduled for this type of cataract surgery with a specific lens implant. Some eye conditions or other health issues could make you ineligible. This study aims to help doctors understand if preloaded injectors offer better surgical results and fewer complications compared to the manual injector.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Ast Products, Inc.
AST Products, Inc. is a leading clinical trial sponsor dedicated to advancing innovative medical solutions through rigorous research and development. With a focus on enhancing patient care, the company specializes in the design and execution of clinical trials that evaluate the safety and efficacy of cutting-edge therapeutic products. Leveraging a team of experienced professionals and robust methodologies, AST Products, Inc. is committed to adhering to the highest regulatory standards while fostering collaboration with healthcare providers and research institutions. Their mission is to bring transformative healthcare solutions to market, ultimately improving outcomes for patients globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sevilla, Spain
Patients applied
Trial Officials
Adrián Hernández Martínez, MD, PhD
Principal Investigator
OftalVist Sevilla
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported