CataractNCT04884178
PMCF Study of Preloaded Trifocal IOL
A study testing Trifocal Preloaded IOL Delivery System in people with Cataract, run by ICARES Medicus, Inc. at 1 site in Taiwan.
Trial summary
This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Trifocal Preloaded IOL Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Aug 2021to 22 Aug 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral cataracts: Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts
- Desire for high post-operative spectacle independence
- Willingness to cooperate with and complete all post-operative visits
- Calculated lens power within +5.0 D and +34.0 D
- Planned cataract removal by phacoemulsification
- Clear intraocular media other that cataracts in both eyes
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- Potential post-operative visual acuity of 20/25 or better
- Ability to comprehend and sign an informed consent
- Signed informed consent
Who cannot join
- More than 1.0 D of pre-operative corneal astigmatism
- Expected post-operative astigmatism of more than 0.75 D
- Mature/dense cataract which makes the pre-operative fundus examination difficult
- Previous ocular surgery or trauma
- Clinically significant irregular astigmatism
- Choroidal hemorrhage
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- Microphthalmos
- Severe corneal dystrophy
- Medically controlled or uncontrolled glaucoma
- Clinically significant macular/RPE changes
- Concomitant severe eye disease
- Severe optic nerve atrophy
- Diabetic retinopathy, proliferative or macular edema
- Amblyopia
- Extremely shallow anterior chamber
- Chronic sever uveitis
- Pregnant or lactating
- Previous retinal detachment
- Previous corneal transplant
- 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: Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System
This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.
Read the detailed description
This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.
- Conditions
- Cataract
- Being tested
- Trifocal Preloaded IOL Delivery System
- Keywords
- Cataract, Trifocal, IOL, Intraocular lens, Preloaded, Aphakic, Spectacle independence, 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.
Trifocal Preloaded IOL Delivery SystemDevice
Also called Asqelio Trifocal, TFPIO130Y, TFLIO130, aspicio Trifocal
UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan.
| Study group | Role | What they receive |
|---|---|---|
| Trifocal Preloaded IOL Delivery System | Experimental | Bilateral trifocal IOLs implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery Receives: Device: Trifocal Preloaded IOL Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photopic monocular CDVA, 400 cm
Measured: 6 Months post second eye implantation
Photopic monocular CIVA, 60 cm
Measured: 6 Months post second eye implantation
Photopic monocular CNVA, 40 cm
Measured: 6 Months post second eye implantation
Rates of adverse events vs. ISO 11979-7:2018 SPE rate
Measured: 6 Months post second eye implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start23 Aug 2021
- Primary completion18 Apr 2022
- Study completion22 Aug 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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, Dr., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884178
- Sponsor's protocol ID
- CPRO-000001
- Status last verified
- Apr 2024
- First submitted
- 7 May 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System
- ClinicalTrials.gov ID
- NCT04884178
- Acronym / sponsor ID
- CPRO-000001
- Conditions
- Cataract
- Keywords
- Cataract, Trifocal, IOL, Intraocular lens, Preloaded, Aphakic, Spectacle independence, Asqelio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ICARES Medicus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AST Products, Inc.
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 12 May 2021 (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 a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.
Detailed description
This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trifocal Preloaded IOL Delivery System | Experimental | Device: Trifocal Preloaded IOL Delivery SystemBilateral trifocal IOLs implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bilateral cataracts: Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts
- Desire for high post-operative spectacle independence
- Willingness to cooperate with and complete all post-operative visits
- Calculated lens power within +5.0 D and +34.0 D
- Planned cataract removal by phacoemulsification
Key exclusion criteria (21 listed)
- More than 1.0 D of pre-operative corneal astigmatism
- Expected post-operative astigmatism of more than 0.75 D
- Mature/dense cataract which makes the pre-operative fundus examination difficult
- Previous ocular surgery or trauma
- Clinically significant irregular astigmatism
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 |
|---|---|---|
| Trifocal Preloaded IOL Delivery SystemAlso: Asqelio Trifocal, TFPIO130Y, TFLIO130, aspicio TrifocalUV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan. | Device | Trifocal Preloaded IOL Delivery System |
Primary outcome
Photopic monocular CDVA, 400 cm
Time frame: 6 Months post second eye implantation
Photopic monocular CIVA, 60 cm
Time frame: 6 Months post second eye implantation
Photopic monocular CNVA, 40 cm
Time frame: 6 Months post second eye implantation
Rates of adverse events vs. ISO 11979-7:2018 SPE rate
Time frame: 6 Months post second eye 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 19 Apr 2024.
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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, Dr. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifocal Preloaded IOL Delivery System in people with 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 9 inclusion and 21 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 19 Apr 2024. 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?
Photopic monocular CDVA, 400 cm (time frame: 6 Months post second eye implantation). The study lists 4 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 19 Apr 2024.