Safety and Efficacy of the Bi-Aspheric Monofocal IOL

NCT06380478 | Completed

• 1 other identifier: CPRO-000012
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract; Monofocal; Intraocular lens; Preloaded; Aphakic; Asqelio; aspicio; AST Products; ICARES

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• UDVA

  3 months after implantation

• UIVA

  3 months after implantation

• CIVA

  3 months after implantation

• IOL glistening

  3 months after implantation

• PCO

  3 months after implantation

Study Arms (1)

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

Interventions

aspicio Monofocal IOL DEVICE

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

Also known as: aspicio Monofocal, Asqelio Monofocal, ASPP60Y, ASP60Y, QPIO103Y, QLIO103Y

aspicio Monofocal IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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).
• Previous ocular surgery (including YAG-laser) or trauma
• Clinically significant irregular astigmatism
• Concomitant severe eye disease
• Pregnant or lactating
• Any other ocular or systemic condition which, in the opinion of the investigator, should exclude the subject from the study
• Concurrent participation in another drug or device investigation
• May be expected to require other ocular surgery during the study

Sponsors & Collaborators

• ICARES Medicus, Inc.: lead
• AST Products, Inc.: collaborator

Study Sites (1)

Chang Gung University Hospital

Taoyuan District, Guishan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Yih-Shiou Hwang, MD

  Chang Gung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: March 5, 2024
• Primary Completion: August 12, 2025
• Study Completion: August 19, 2025
• Last Updated: April 20, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)