CorneaNCT04969406
A Prospective Trial of the Intelon BOSS(TM) System
A study testing Brillouin Spectroscopy via BOSS System in people with Cornea and Lens Diseases, run by Intelon Optics, Inc at 1 site in United States.
Trial summary
A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cornea, Lens Diseases
- What is being tested?
- Brillouin Spectroscopy via BOSS System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2021to 10 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
- Signed Written Informed Consent
Who cannot join
- No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
- Presence of corneal opacity
- Presence of cortical cataracts visible in an undilated pupil
- Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(TM) System
A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.
- Conditions
- Cornea, Lens Diseases
- Being tested
- Brillouin Spectroscopy via BOSS System
- Medical subject headings
- Corneal Diseases, Lens Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brillouin Spectroscopy via BOSS SystemOther
Biomechanical Imaging of the Cornea and Lens
| Study group | Role | What they receive |
|---|---|---|
| Imaging by BOSS System | Experimental | Imaging by the BOSS System Receives: Other: Brillouin Spectroscopy via BOSS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility
A random effect model will be used to assess variation due to device/operator configuration
Measured: Evaluation Visit (within 30 days of the Screening Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start24 Jul 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Why it stopped: Enrollment Difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intelon Optics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969406
- Sponsor's protocol ID
- P21-02
- Status last verified
- Mar 2022
- First submitted
- 7 Jul 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(TM) System
- ClinicalTrials.gov ID
- NCT04969406
- Acronym / sponsor ID
- P21-02
- Conditions
- Cornea, Lens Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment Difficulty
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Intelon Optics, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 20 Jul 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.
A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging by BOSS System | Experimental | Other: Brillouin Spectroscopy via BOSS SystemImaging by the BOSS System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
- Signed Written Informed Consent
Key exclusion criteria (4 listed)
- No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
- Presence of corneal opacity
- Presence of cortical cataracts visible in an undilated pupil
- Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).
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 |
|---|---|---|
| Brillouin Spectroscopy via BOSS SystemBiomechanical Imaging of the Cornea and Lens | Other | Imaging by BOSS System |
Primary outcome
Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility
Time frame: Evaluation Visit (within 30 days of the Screening Visit)
A random effect model will be used to assess variation due to device/operator configuration
Results and safety
The study was stopped early (reason given: Enrollment Difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brillouin Spectroscopy via BOSS System in people with Cornea and Lens Diseases, run by Intelon Optics, Inc at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 10 Jun 2022. 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 United States. 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 was stopped early (reason given: Enrollment Difficulty). Results are not available in the source record.
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?
Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility (time frame: Evaluation Visit (within 30 days of the Screening Visit)). 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 10 Jun 2022.