Fuchs Endothelial Corneal DysfunctionNCT07780890
A Study to Assess Brillouin Hydration Mapping for the Evaluation of Ocular Tissues and Diseases
An observational study of Fuchs Endothelial Corneal Dysfunction and Open Angle Glaucoma (OAG), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The overall goal of this study is to develop Brillouin microscope as a novel tool for measuring biomechanical and hydration properties of human tissues in vivo. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Fuchs Endothelial Corneal Dysfunction, Open Angle Glaucoma (OAG), Dry Eye Disease (DED)
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aim 1 - Control Group (Healthy Subjects) : 10 subjects per 6 age ranges (20-29yr, 30-39yr, 40-49yr, 50-59yr, 60-69yr, 70-79yr), total 60 subjects Aim 2 - Patient Groups : 20 patients per 6 diseases (Moderate Fuchs' endothelial dystrophy, Early-stage isolated corneal guttae, Primary open-angle glaucoma, Dry eye disease, Keratoconus, post-LASIK), total 120 patients.
Who may be able to join
- Healthy volunteers with normal eyes
- Visual acuity between +2 to -6 diopters
Who cannot join
- History of refractive or cataract surgery
- History of ocular disease
- Active non-ophthalmic systemic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Brigham
Boston, Massachusetts, 02114
Soyeon (Selina) Ahn, PhD, 3396009736, sahn14@mgh.harvard.edu
Seok-Hyun Yun, PhD, 6177688704, syun@mgh.harvard.edu
About this study
The overall goal of this study is to develop Brillouin microscope as a novel tool for measuring biomechanical and hydration properties of human tissues in vivo.
Read the detailed description
Our long-term goal is to establish a direct, accurate, and clinically viable method for measuring corneal hydration, enabling earlier detection, more precise diagnosis, and improved management of corneal diseases and postoperative complications. The objective of this study is to develop and validate Brillouin based hydration mapping as a diagnostic tool to quantify water content in the cornea across healthy individuals and patients with diverse ocular conditions. Our central hypothesis is that spatially resolved Brillouin frequency shifts can reveal disease-specific hydration profiles that are not detectable through conventional thickness-based methods. This hypothesis is based on recent evidence from our group demonstrating that Brillouin microscopy is sensitive to hydration. The rationale for this research is that Brillouin-based hydration maps will offer an unprecedented, morphology-independent metric of corneal fluid balance, which could improve clinical decision-making in a range of pathologies.
- Conditions
- Fuchs Endothelial Corneal Dysfunction, Open Angle Glaucoma (OAG), Dry Eye Disease (DED), Keratoconus, Lasik Eye Surgery
- Keywords
- cornea, biomechanics, brillouin microscopy
- Medical subject headings
- Glaucoma, Open-Angle, Dry Eye Syndromes, Keratoconus, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Healthy Subjects | |
| Patient Group | Patient Subjects (Fuch's endothelial dystrophy, Corneal guttae, Open-angle glaucoma, Dry eye disease, Keratoconus, post-LASIK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects to successfully complete Brillouin measurement without serious unanticipated adverse events related to application of the device.
Number and percentage of enrolled subjects who complete the single Brillouin imaging session without experiencing a serious unanticipated adverse event related to the investigational Brillouin Ocular Scanner, as determined by study staff monitoring during and immediately following the imaging procedure.
Measured: Through completion of the single study visit, approximately 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start18 Aug 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fuchs Endothelial Corneal DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Seok Hyun Yun, Massachusetts General Hospital
- Investigators
- Seok-Hyun Yun, PhD, Principal investigator, Massachusetts General Brigham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780890
- Sponsor's protocol ID
- 2025P002530
- Other IDs
- R01EY038655-01
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryu S, Martino N, Kwok SJJ, Bernstein L, Yun SH. Label-free histological imaging of tissues using Brillouin light scattering contrast. Biomed Opt Express. 2021 Feb 17;12(3):1437-1448. doi: 10.1364/BOE.414474. eCollection 2021 Mar 1.
PubMed 33796364Eltony AM, Shao P, Yun SH. Measuring mechanical anisotropy of the cornea with Brillouin microscopy. Nat Commun. 2022 Mar 15;13(1):1354. doi: 10.1038/s41467-022-29038-5.
PubMed 35293388Chow DM, Yun SH. Pulsed stimulated Brillouin microscopy. Opt Express. 2023 Jun 5;31(12):19818-19827. doi: 10.1364/OE.489158.
PubMed 37381389
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Brillouin Hydration Mapping for the Evaluation of Ocular Tissues and Diseases
- ClinicalTrials.gov ID
- NCT07780890
- Acronym / sponsor ID
- 2025P002530
- Conditions
- Fuchs Endothelial Corneal Dysfunction, Open Angle Glaucoma (OAG), Dry Eye Disease (DED), Keratoconus, Lasik Eye Surgery
- Keywords
- cornea, biomechanics, brillouin microscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary, National Eye Institute (NEI)
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Aug 2026 (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.
The overall goal of this study is to develop Brillouin microscope as a novel tool for measuring biomechanical and hydration properties of human tissues in vivo.
Detailed description
Our long-term goal is to establish a direct, accurate, and clinically viable method for measuring corneal hydration, enabling earlier detection, more precise diagnosis, and improved management of corneal diseases and postoperative complications. The objective of this study is to develop and validate Brillouin based hydration mapping as a diagnostic tool to quantify water content in the cornea across healthy individuals and patients with diverse ocular conditions. Our central hypothesis is that spatially resolved Brillouin frequency shifts can reveal disease-specific hydration profiles that are not detectable through conventional thickness-based methods. This hypothesis is based on recent evidence from our group demonstrating that Brillouin microscopy is sensitive to hydration. The rationale for this research is that Brillouin-based hydration maps will offer an unprecedented, morphology-independent metric of corneal fluid balance, which could improve clinical decision-making in a range of pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Healthy Subjects |
| Patient Group | – | –Patient Subjects (Fuch's endothelial dystrophy, Corneal guttae, Open-angle glaucoma, Dry eye disease, Keratoconus, post-LASIK) |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aim 1 - Control Group (Healthy Subjects) : 10 subjects per 6 age ranges (20-29yr, 30-39yr, 40-49yr, 50-59yr, 60-69yr, 70-79yr), total 60 subjects Aim 2 - Patient Groups : 20 patients per 6 diseases (Moderate Fuchs' endothelial dystrophy, Early-stage isolated corneal guttae, Primary open-angle glaucoma, Dry eye disease, Keratoconus, post-LASIK), total 120 patients.
Key inclusion criteria (2 listed)
- Healthy volunteers with normal eyes
- Visual acuity between +2 to -6 diopters
Key exclusion criteria (3 listed)
- History of refractive or cataract surgery
- History of ocular disease
- Active non-ophthalmic systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects to successfully complete Brillouin measurement without serious unanticipated adverse events related to application of the device.
Time frame: Through completion of the single study visit, approximately 1-2 hours
Number and percentage of enrolled subjects who complete the single Brillouin imaging session without experiencing a serious unanticipated adverse event related to the investigational Brillouin Ocular Scanner, as determined by study staff monitoring during and immediately following the imaging procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 33796364Ryu S, Martino N, Kwok SJJ, Bernstein L, Yun SH. Label-free histological imaging of tissues using Brillouin light scattering contrast. Biomed Opt Express. 2021 Feb 17;12(3):1437-1448. doi: 10.1364/BOE.414474. eCollection 2021 Mar 1.
- Background: PubMed 35293388Eltony AM, Shao P, Yun SH. Measuring mechanical anisotropy of the cornea with Brillouin microscopy. Nat Commun. 2022 Mar 15;13(1):1354. doi: 10.1038/s41467-022-29038-5.
- Background: PubMed 37381389Chow DM, Yun SH. Pulsed stimulated Brillouin microscopy. Opt Express. 2023 Jun 5;31(12):19818-19827. doi: 10.1364/OE.489158.
- 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.
Seok-Hyun Yun, PhD principal investigator
Massachusetts General Brigham
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 Fuchs Endothelial Corneal Dysfunction and Open Angle Glaucoma (OAG), run by Massachusetts General Hospital 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Aug 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soyeon (Selina) Ahn, PhD (3396009736, sahn14@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects to successfully complete Brillouin measurement without serious unanticipated adverse events related to application of the device. (time frame: Through completion of the single study visit, approximately 1-2 hours). 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 NCT07780890, which also lists 3 linked publications.
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 25 Aug 2026.