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CompletedNCT06380478Updated Apr 20, 2026

Safety and Efficacy of the Bi-Aspheric Monofocal IOL

An observational study in Cataract, sponsored by ICARES Medicus, Inc.. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by ICARES Medicus, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract

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Keywords

  • Cataract
  • Monofocal
  • Intraocular lens
  • Preloaded
  • Aphakic
  • Asqelio
  • aspicio
  • AST Products
  • ICARES
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 30 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

ICARES Medicus, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Deviceaspicio 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

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

06

What researchers measure

Primary outcomes

  1. CDVA

    Photopic monocular best corrected distance visual acuity (CDVA), 400cm

    Time frame: 3 months after implantation

  2. Defocus curve

    Photopic monocular defocus curve, -4.0 D \~ +2.0 D

    Time frame: 3 months after implantation

Secondary outcomes

  1. UDVA

    Photopic monocular uncorrected distance visual acuity (UDVA), 400cm

    Time frame: 3 months after implantation

  2. UIVA

    Photopic monocular uncorrected intermediate visual acuity (UIVA), 60cm

    Time frame: 3 months after implantation

  3. CIVA

    Photopic monocular corrected intermediate visual acuity (CIVA), 60cm

    Time frame: 3 months after implantation

  4. IOL glistening

    IOL glistening observation

    Time frame: 3 months after implantation

  5. PCO

    Posterior Capsular Opacification observation

    Time frame: 3 months after implantation

  6. Satisfaction questionnaire

    Satisfaction questionnaire

    Time frame: 3 months after implantation

  7. AE

    Signs of inflammation and AEs

    Time frame: 3 months after implantation

07

Study locations

1 site
  • Chang Gung University Hospital
    Taoyuan, Guishan District 333, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06380478
Lead sponsor
ICARES Medicus, Inc.
Collaborators
AST Products, Inc.
Responsible party
Sponsor
First posted
Apr 24, 2024
Start date
Mar 5, 2024
Primary completion
Aug 12, 2025
Completion
Aug 19, 2025
Last update
Apr 20, 2026

Study contacts

Yih-Shiou Hwang, MD
principal investigator · Chang Gung University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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