Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
NCT ID: NCT07140029
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-08-31
2025-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pioli™ rD
Participants receiving the pioli™ preloaded injector with the rD model, used for IOL powers \< 25.5 diopters
No interventions assigned to this group
pioli™ Plus rD
Participants receiving the pioli™ Plus preloaded injector with the rD model, used for IOL powers \< 25.5 diopters
No interventions assigned to this group
lioli™ <25.5D
Participants receiving the lioli™ manually loaded injector for IOL powers \< 25.5 diopters
No interventions assigned to this group
pioli™ rC
Participants receiving the pioli™ preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters
No interventions assigned to this group
pioli™ Plus rC
Participants receiving the pioli™ Plus preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters
No interventions assigned to this group
lioli™ ≥25.5D
Participants receiving the lioli™ manually loaded injector for IOL powers ≥ 25.5 diopters
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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AST Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adrián Hernández Martínez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
OftalVist Sevilla
Locations
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Clínica OftalVist Sevilla
Seville, Sevilla, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PIOLI012022
Identifier Type: -
Identifier Source: org_study_id
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