CataractNCT06380478
Safety and Efficacy of the Bi-Aspheric Monofocal IOL
An observational study of Cataract, run by ICARES Medicus, Inc. at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- aspicio Monofocal IOL
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2024to 19 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female adult patients who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Cataract
- Being tested
- aspicio Monofocal IOL
- Keywords
- Cataract, Monofocal, Intraocular lens, Preloaded, Aphakic, Asqelio, aspicio, AST Products, ICARES
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspicio Monofocal IOLDevice
Also called aspicio Monofocal, Asqelio Monofocal, ASPP60Y, ASP60Y
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: aspicio Monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDVA
Photopic monocular best corrected distance visual acuity (CDVA), 400cm
Measured: 3 months after implantation
Defocus curve
Photopic monocular defocus curve, -4.0 D ~ +2.0 D
Measured: 3 months after implantation
Secondary outcomes (7)
UDVA
Photopic monocular uncorrected distance visual acuity (UDVA), 400cm
Measured: 3 months after implantation
UIVA
Photopic monocular uncorrected intermediate visual acuity (UIVA), 60cm
Measured: 3 months after implantation
CIVA
Photopic monocular corrected intermediate visual acuity (CIVA), 60cm
Measured: 3 months after implantation
IOL glistening
IOL glistening observation
Measured: 3 months after implantation
PCO
Posterior Capsular Opacification observation
Measured: 3 months after implantation
Satisfaction questionnaire
Satisfaction questionnaire
Measured: 3 months after implantation
AE
Signs of inflammation and AEs
Measured: 3 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start5 Mar 2024
- Primary completion12 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICARES Medicus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AST Products, Inc.
- Responsible party
- Sponsor
- Investigators
- Yih-Shiou Hwang, MD, Principal investigator, Chang Gung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380478
- Sponsor's protocol ID
- CPRO-000012
- Status last verified
- Aug 2025
- First submitted
- 18 Apr 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT06380478
- Acronym / sponsor ID
- CPRO-000012
- Conditions
- Cataract
- Keywords
- Cataract, Monofocal, Intraocular lens, Preloaded, Aphakic, Asqelio, aspicio, AST Products
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ICARES Medicus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AST Products, Inc.
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aspicio Monofocal IOL | – | Device: aspicio Monofocal IOLA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female adult patients who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspicio Monofocal IOLAlso: aspicio Monofocal, Asqelio Monofocal, ASPP60Y, ASP60YA 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 |
Primary outcome
CDVA
Time frame: 3 months after implantation
Photopic monocular best corrected distance visual acuity (CDVA), 400cm
Defocus curve
Time frame: 3 months after implantation
Photopic monocular defocus curve, -4.0 D ~ +2.0 D
7 secondary outcomes
UDVA
Time frame: 3 months after implantation
UIVA
Time frame: 3 months after implantation
CIVA
Time frame: 3 months after implantation
IOL glistening
Time frame: 3 months after implantation
PCO
Time frame: 3 months after implantation
Satisfaction questionnaire
Time frame: 3 months after implantation
AE
Time frame: 3 months after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yih-Shiou Hwang, MD principal investigator
Chang Gung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by ICARES Medicus, Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDVA (time frame: 3 months after implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.