Measurement of the Elasticity of the Anterior Eye SegmentBrillouin INCT01775007
A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer
A study testing Brillouin Ocular Analyser in people with Measurement of the Elasticity of the Anterior Eye Segment, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis is that the instrument can measure the Brillouin light scattering spectra from the eye safely and effectively from human subjects. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Measurement of the Elasticity of the Anterior Eye Segment
- What is being tested?
- Brillouin Ocular Analyser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Sep 2017
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 20-60
- No refractional abnormalities
- Clear enough cornea and media to permit imaging
Who cannot join
- Occludable narrow angles (without a patent peripheral iridotomy)
- Other ocular or systemic pathology, which precludes safe eye dilation
- LASIK eye surgery
- Allergies to the dilation medication
- Only one healthy eye
- Pregnant women or expected pregnancy within the timeframe of the study
- Do not or cannot understand the instructions for the imaging
- Restricted mobility
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis is that the instrument can measure the Brillouin light scattering spectra from the eye safely and effectively from human subjects.
- Being tested
- Brillouin Ocular Analyser
- Keywords
- Lens, Cornea, Presbyopia
- Medical subject headings
- Corneal Diseases, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brillouin Ocular AnalyserDevice
Measurement of the local viscoelastic properties (Brillouin Shift) of the Anterior Eye Segment.
| Study group | Role | What they receive |
|---|---|---|
| Normal Healthy Subjects | Experimental | Brillouin Ocular Analyser Receives: Device: Brillouin Ocular Analyser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Complete standard eye exam including medical and ocular history with manifest refraction, Amsler grid evaluation (macular test), color vision (Ishihara color plates), Scotopic pupil measurement (Colvard pupillometer), Slit lamp biomicroscopy of anterior segment, intraocular pressure measurement, dilated fundoscopic exam (2.5% phenylephrine and 0.5% tropicamide), and corneal topography (Pentacam).
Measured: 6 months
Secondary outcomes (1)
Sensitivity and accuracy of Brillouin modulus measurement.
It will be tested if, with the parameters designed for in vivo operation, the Brillouin ocular analyzer is sensitive enough to characterize the elasticity of cornea and crystalline lens as well as its spatial distribution within the ocular tissue.
Measured: at time of imaging session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startMar 2011
- Primary completionSep 2017
- Study completionSep 2017
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 Measurement of the Elasticity of the Anterior Eye SegmentStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Hyun Yun, Massachusetts General Hospital
- Investigators
- Seok-Hyun Yun, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775007
- Sponsor's protocol ID
- 2008-P-002176/10
- Acronym
- Brillouin I
- Status last verified
- Jul 2022
- First submitted
- 22 Jan 2013
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Scarcelli G, Yun SH. In vivo Brillouin optical microscopy of the human eye. Opt Express. 2012 Apr 9;20(8):9197-202. doi: 10.1364/OE.20.009197.
PubMed 22513631
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer
- ClinicalTrials.gov ID
- NCT01775007
- Acronym / sponsor ID
- Brillouin I / 2008-P-002176/10
- Keywords
- Lens, Cornea, Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Jan 2013 (estimated)
- 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 Brillouin ocular analyzer uses a low-power near infrared laser light to probe the viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis is that the instrument can measure the Brillouin light scattering spectra from the eye safely and effectively from human subjects.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Subjects | Experimental | Device: Brillouin Ocular AnalyserBrillouin Ocular Analyser |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers aged 20-60
- No refractional abnormalities
- Clear enough cornea and media to permit imaging
Key exclusion criteria (8 listed)
- Occludable narrow angles (without a patent peripheral iridotomy)
- Other ocular or systemic pathology, which precludes safe eye dilation
- LASIK eye surgery
- Allergies to the dilation medication
- Only one healthy eye
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 Ocular AnalyserMeasurement of the local viscoelastic properties (Brillouin Shift) of the Anterior Eye Segment. | Device | Normal Healthy Subjects |
Primary outcome
Number of patients with adverse events
Time frame: 6 months
Complete standard eye exam including medical and ocular history with manifest refraction, Amsler grid evaluation (macular test), color vision (Ishihara color plates), Scotopic pupil measurement (Colvard pupillometer), Slit lamp biomicroscopy of anterior segment, intraocular pressure measurement, dilated fundoscopic exam (2.5% phenylephrine and 0.5% tropicamide), and corneal topography (Pentacam).
1 secondary outcome
Sensitivity and accuracy of Brillouin modulus measurement.
Time frame: at time of imaging session
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 2 Aug 2022.
- Results publication: PubMed 22513631Scarcelli G, Yun SH. In vivo Brillouin optical microscopy of the human eye. Opt Express. 2012 Apr 9;20(8):9197-202. doi: 10.1364/OE.20.009197.
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.
Seok-Hyun Yun, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brillouin Ocular Analyser in people with Measurement of the Elasticity of the Anterior Eye Segment, run by Massachusetts General Hospital at 2 sites 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 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Number of patients with adverse events (time frame: 6 months). 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 NCT01775007, 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 2 Aug 2022.