Clinical trial NCT06380478: Safety and Efficacy of the Bi-Aspheric Monofocal IOL
Official title: Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Keywords: Cataract
Monofocal
Intraocular lens
Preloaded
Aphakic
Asqelio
aspicio
AST Products
ICARES
Lead sponsor: ICARES Medicus, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AST Products, Inc.
First posted: 2024-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female adult patients who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: CDVA
timeFrame: 3 months after implantation
measure: Defocus curve
timeFrame: 3 months after implantation
Secondary outcomes:
measure: UDVA
timeFrame: 3 months after implantation
measure: UIVA
timeFrame: 3 months after implantation
measure: CIVA
timeFrame: 3 months after implantation
measure: IOL glistening
timeFrame: 3 months after implantation
measure: PCO
timeFrame: 3 months after implantation
measure: Satisfaction questionnaire
timeFrame: 3 months after implantation
measure: AE
timeFrame: 3 months after implantation
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University Hospital
state: Guishan District
Study officials:
affiliation: Chang Gung University Hospital
name: Yih-Shiou Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References: