CataractNCT03824028
Post-Market Clinical Survey of Clareon® IOL AutonoMe™ in Japanese Subjects
An observational study of Cataract, run by Alcon Research at 3 sites in Japan.
Trial summary
This purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon® IOL AutonoMe™ automated preloaded delivery system
- Type of treatment
- Medical device
- How many people
- 384 participants
- Where
- 3 sitesJapan
- Study dates
- 10 Feb 2019to 20 Oct 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be enrolled at approximately 20 investigative sites located in Japan.
Who may be able to join
- Able to comprehend and willing to sign informed consent.
- Prior diagnosis of age-related cataracts.
- Prior cataract surgery with implantation of Clareon IOL in the capsular bag by AutonoMe™.
- No ophthalmic disease which might affect visual acuity.
Who cannot join
- None.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Alcon Investigative Site
Hashimoto, Wakayama, 648-0073
Alcon Investigative Site
Yokkaichi, Mie-ken, 510-0085
Alcon Investigative Site
Yokohama, Kanagawa, 220-0011
About this study
Official title: Post-Market Clinical Survey of Clareon® IOL With the AutonoMe™ Automated Preloaded Delivery System With Japanese Subjects
This purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice.
Read the detailed description
This study will enroll subjects who underwent prior cataract surgery with phacoemulsification and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system. Subjects will be enrolled post-operatively and followed for one year.
- Conditions
- Cataract
- Being tested
- Clareon® IOL AutonoMe™ automated preloaded delivery system
- Keywords
- Cataract surgery, Intraocular lens, IOL, Clareon, AutonoMe
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon® IOL AutonoMe™ automated preloaded delivery systemDevice
Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Clareon IOL AutonoMe | Prior implantation with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system Receives: Device: Clareon® IOL AutonoMe™ automated preloaded delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected distance visual acuity
Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart.
Measured: Up to Year 1 postoperative
Intraocular lens (IOL) delivery performance
A questionnaire will be used to retrospectively evaluate the usability of AutonoME™. The investigator will respond to 8 questions pertaining to the IOL delivery performance using a 5-point scale where 1 = very good/strongly agree and 5 = very poor/strongly disagree.
Measured: Surgery day (retrospective)
Difference between target refraction and postoperative subjective refraction (spherical equivalent)
Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. Subjective refraction at best corrected distance vision will be recorded and compared with target refraction determined on day of surgery.
Measured: Up to Year 1 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start10 Feb 2019
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon Research, Study director, Alcon Japan, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824028
- Sponsor's protocol ID
- ILM171-P001
- Status last verified
- Mar 2021
- First submitted
- 29 Jan 2019
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oshika T, Sasaki N; Clinical Study Group on New Intraocular Lens and Delivery System. One-year multicenter evaluation of a new hydrophobic acrylic intraocular lens with hydroxyethyl methacrylate in an automated preloaded delivery system. J Cataract Refract Surg. 2022 Mar 1;48(3):275-279. doi: 10.1097/j.jcrs.0000000000000746.
PubMed 34261986
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Survey of Clareon® IOL With the AutonoMe™ Automated Preloaded Delivery System With Japanese Subjects
- ClinicalTrials.gov ID
- NCT03824028
- Acronym / sponsor ID
- ILM171-P001
- Conditions
- Cataract
- Keywords
- Cataract surgery, Intraocular lens, IOL, Clareon, AutonoMe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 31 Jan 2019 (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 purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice.
Detailed description
This study will enroll subjects who underwent prior cataract surgery with phacoemulsification and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system. Subjects will be enrolled post-operatively and followed for one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clareon IOL AutonoMe | – | Device: Clareon® IOL AutonoMe™ automated preloaded delivery systemPrior implantation with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled at approximately 20 investigative sites located in Japan.
Key inclusion criteria (4 listed)
- Able to comprehend and willing to sign informed consent.
- Prior diagnosis of age-related cataracts.
- Prior cataract surgery with implantation of Clareon IOL in the capsular bag by AutonoMe™.
- No ophthalmic disease which might affect visual acuity.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Clareon® IOL AutonoMe™ automated preloaded delivery systemDisposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery | Device | Clareon IOL AutonoMe |
Primary outcome
Best-corrected distance visual acuity
Time frame: Up to Year 1 postoperative
Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart.
Intraocular lens (IOL) delivery performance
Time frame: Surgery day (retrospective)
A questionnaire will be used to retrospectively evaluate the usability of AutonoME™. The investigator will respond to 8 questions pertaining to the IOL delivery performance using a 5-point scale where 1 = very good/strongly agree and 5 = very poor/strongly disagree.
Difference between target refraction and postoperative subjective refraction (spherical equivalent)
Time frame: Up to Year 1 postoperative
Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. Subjective refraction at best corrected distance vision will be recorded and compared with target refraction determined on day of surgery.
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 10 Mar 2021.
- Derived from this study: PubMed 34261986Oshika T, Sasaki N; Clinical Study Group on New Intraocular Lens and Delivery System. One-year multicenter evaluation of a new hydrophobic acrylic intraocular lens with hydroxyethyl methacrylate in an automated preloaded delivery system. J Cataract Refract Surg. 2022 Mar 1;48(3):275-279. doi: 10.1097/j.jcrs.0000000000000746.
- 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.
Alcon Research study director
Alcon Japan, Ltd.
3 sites 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 Alcon Research at 3 sites in Japan.
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 4 inclusion and 1 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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?
Best-corrected distance visual acuity (time frame: Up to Year 1 postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824028, which also lists 1 linked publication.
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 10 Mar 2021.