Safety and Efficacy of the Bi-Aspheric Monofocal IOL

Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: aspicio Monofocal IOL

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Taiwan
  • Guishan District
    • Taoyuan District, Guishan District, Taiwan, 333
      • Chang Gung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
aspicio Monofocal IOL; 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	Device: aspicio Monofocal IOL; 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; Other Names: aspicio Monofocal; Asqelio Monofocal; ASPP60Y; ASP60Y; QPIO103Y; QLIO103Y

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDVA	Photopic monocular best corrected distance visual acuity (CDVA), 400cm	3 months after implantation
Defocus curve	Photopic monocular defocus curve, -4.0 D ~ +2.0 D	3 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDVA	Photopic monocular uncorrected distance visual acuity (UDVA), 400cm	3 months after implantation
UIVA	Photopic monocular uncorrected intermediate visual acuity (UIVA), 60cm	3 months after implantation
CIVA	Photopic monocular corrected intermediate visual acuity (CIVA), 60cm	3 months after implantation
IOL glistening	IOL glistening observation	3 months after implantation
PCO	Posterior Capsular Opacification observation	3 months after implantation
Satisfaction questionnaire	Satisfaction questionnaire	3 months after implantation
AE	Signs of inflammation and AEs	3 months after implantation

Collaborators and Investigators

• Sponsor: ICARES Medicus, Inc.
• Collaborators: AST Products, Inc.
• Investigators: Principal Investigator: Yih-Shiou Hwang, MD, Chang Gung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Actual): August 12, 2025
• Study Completion (Actual): August 19, 2025

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cataract; Intraocular lens; Monofocal; Preloaded; Aphakic; Asqelio; aspicio; AST Products; ICARES
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CPRO-000012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No