Safety and Efficacy of the Bi-Aspheric Monofocal IOL

ICARES Medicus

Status: Enrolling

Conditions: Cataract

Treatments: Device: aspicio Monofocal IOL

Study type: Observational

Funder types: Industry

Identifiers

NCT06380478

CPRO-000012

Details and patient eligibility

About

This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.

Full description

This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a single visit in the facilities of Chang Gung University Hospital at least 3 months after the surgery. Patients will undergo a routine basic ophthalmological examination.

Additionally, and retrospectively, the patients' medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery.

The data corresponding to the preoperative values of corneal curvature (flat meridian, curved meridian and axes), axial length measured by biometry, visual acuity and those corresponding to the implanted IOL will also be collected from the medical records.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye
2. Willingness to cooperate with and complete all post-operative visits
3. Ability to comprehend and sign an informed consent

Exclusion criteria

1. Any pathology that could reduce Visual Acuity (VA) (including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely narrow anterior chamber depth, microphthalmos, clinically significant macular/RPE changes, retinal detachment, corneal transplant, chronic sever uveitis, choroidal hemorrhage, recurrent severe inflammation of the anterior or posterior segment of unknown etiology, iris neovascularization, medically controlled or uncontrolled glaucoma, clinically significant macular degeneration, or diagnosis of pseudoexfoliation).
2. Previous ocular surgery (including YAG-laser) or trauma
3. Clinically significant irregular astigmatism
4. Concomitant severe eye disease
5. Pregnant or lactating
6. Any other ocular or systemic condition which, in the opinion of the investigator, should exclude the subject from the study
7. Concurrent participation in another drug or device investigation
8. May be expected to require other ocular surgery during the study

Trial design

30 participants in 1 patient group

aspicio Monofocal IOL

Description:

A bi-aspheric monofocal IOL is implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery

Treatment:

Device: aspicio Monofocal IOL