GlaucomaNCT06993597
Study of Corneal Biomechanics in Glaucoma Patients Using Brillouin Microscopy
An observational study of Glaucoma, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This pilot study evaluates the biomechanical properties of the cornea in glaucoma patients using Brillouin microscopy, a non-contact imaging technique. The study aims to compare corneal stiffness between patients with normal-tension glaucoma, high-tension glaucoma, and healthy controls, and to assess changes in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Prostaglandin Analogue -Containing IOP-Lowering Therapy, Beta Blocker and Brillouin Microscopy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes adults aged 18 years and older with newly diagnosed, treatment-naïve primary open angle glaucoma (POAG), including both normal tension glaucoma (NTG) and high tension glaucoma (HTG), as well as age-matched healthy control subjects. Subjects must meet strict ophthalmic inclusion criteria and will be recruited from the University of Maryland Department of Ophthalmology and Visual Sciences and affiliated clinics. Exclusion criteria include significant ocular comorbidities, prior ocular surgery, systemic diseases that affect the eye, or prior glaucoma therapy.
Who may be able to join
- Age 18 years or older
- Diagnosis of primary open angle glaucoma (POAG) or no history of glaucoma (for controls)
- Open angle on gonioscopy (Shaffer grade 3 or 4)
- Best-corrected visual acuity of 20/25 or better
- Refractive error between +3.00 and -5.00 diopters
- No prior use of topical glaucoma medications
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- Diagnosis of:
- High Tension Glaucoma (IOP ≥ 22 mmHg on 3 visits)
- Normal Tension Glaucoma (IOP ≤ 21 mmHg on 3 visits)
- OR age-matched control with normal optic nerve and visual fields
Who cannot join
- Corneal abnormalities or conditions interfering with Brillouin or applanation tonometry
- Retinal diseases affecting RNFL (e.g., macular traction)
- History of ocular surgery or laser
- Diagnosis of diabetes
- History of uveitis
- History of prolonged steroid use
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- Neurodegenerative or systemic diseases (e.g., multiple sclerosis, Alzheimer's, Parkinson's, schizophrenia)
- Unreliable visual fields
- Contraindications to beta blockers (e.g., bradycardia, severe pulmonary disease)
- Moderate to severe glaucoma (per Hodapp-Anderson-Parrish criteria)
- History of contact lens use
- Low blood pressure
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
University of Maryland School of Medicine
Baltimore, Maryland, 21201-1757
Osamah Saeedi, MD, 667-214-1232, eyeresearch@som.umaryland.edu
osaeedi@som.umaryland.edu
About this study
Official title: Development of Robust Corneal Biomechanical Biomarkers for Glaucoma Using Brillouin Microscopy
This pilot study evaluates the biomechanical properties of the cornea in glaucoma patients using Brillouin microscopy, a non-contact imaging technique. The study aims to compare corneal stiffness between patients with normal-tension glaucoma, high-tension glaucoma, and healthy controls, and to assess changes in corneal biomechanics following intraocular pressure (IOP)-lowering treatment. The goal is to determine whether Brillouin-derived biomechanical measurements can serve as biomarkers for glaucoma risk and progression.
Read the detailed description
This study explores the biomechanical properties of the cornea in patients with glaucoma using a novel, non-contact imaging technique called Brillouin microscopy. The technology allows in vivo assessment of tissue stiffness without physical perturbation, potentially offering new insights into glaucoma risk and response to therapy.
The study includes two parts: a cross-sectional comparison between patients with normal- and high-tension glaucoma and healthy controls, and a longitudinal analysis of biomechanical changes following IOP-lowering treatment with either prostaglandin analogs or beta blockers.
The goal is to determine whether corneal biomechanics can serve as a biomarker for glaucoma susceptibility and progression, and to evaluate the feasibility of integrating Brillouin imaging into clinical glaucoma care.
- Conditions
- Glaucoma
- Being tested
- Prostaglandin Analogue -Containing IOP-Lowering Therapy, Beta Blocker, Brillouin Microscopy
- Keywords
- glaucoma, cornea, biomechanics
- Medical subject headings
- Glaucoma, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostaglandin Analogue -Containing IOP-Lowering TherapyDrug
Also called Latanoprost, Travaprost, Bimatoprost
Subjects with glaucoma may be prescribed prostaglandin analogs as part of their clinical care. This group will be observed longitudinally to assess changes in corneal biomechanics.
Beta BlockerDrug
Also called Timolol
Subjects with glaucoma may be prescribed topical beta blockers as part of their clinical care. This group will be observed longitudinally to assess changes in corneal biomechanics.
Brillouin MicroscopyDevice
Also called Brillouin Imaging
Brillouin microscopy is a non-contact optical imaging method used to assess the biomechanical properties of the cornea in vivo with three-dimensional resolution. It will be used to evaluate corneal stiffness in all study subjects.
| Study group | Role | What they receive |
|---|---|---|
| Normal Tension Glaucoma | Newly diagnosed, treatment-naïve subjects with normal tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks. Receives: Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy; Drug: Beta Blocker; Device: Brillouin Microscopy | |
| High Tension Glaucoma | Newly diagnosed, treatment-naïve subjects with high tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks. Receives: Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy; Drug: Beta Blocker; Device: Brillouin Microscopy | |
| Control | Age-matched healthy control subjects with no history of glaucoma or IOP-lowering therapy. Brillouin imaging will be performed at a single time point for cross-sectional comparison. Receives: Device: Brillouin Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corneal Biomechanical Modulus
Brillouin microscopy will be used to measure the corneal modulus of elasticity. The primary outcome is the change in corneal stiffness (Brillouin shift in MHz) across time points in subjects treated with prostaglandin analogs versus beta blockers, and between groups at baseline (NTG, HTG, controls).
Measured: Baseline, 3 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Osamah Saeedi, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993597
- Sponsor's protocol ID
- HP-00110432
- Other IDs
- R21EY035483
- Status last verified
- Aug 2026
- First submitted
- 19 May 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Summary-level results will be published and made publicly available per NIH policy.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Robust Corneal Biomechanical Biomarkers for Glaucoma Using Brillouin Microscopy
- ClinicalTrials.gov ID
- NCT06993597
- Acronym / sponsor ID
- HP-00110432
- Conditions
- Glaucoma
- Keywords
- glaucoma, cornea, biomechanics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 May 2025 (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 pilot study evaluates the biomechanical properties of the cornea in glaucoma patients using Brillouin microscopy, a non-contact imaging technique. The study aims to compare corneal stiffness between patients with normal-tension glaucoma, high-tension glaucoma, and healthy controls, and to assess changes in corneal biomechanics following intraocular pressure (IOP)-lowering treatment. The goal is to determine whether Brillouin-derived biomechanical measurements can serve as biomarkers for glaucoma risk and progression.
Detailed description
This study explores the biomechanical properties of the cornea in patients with glaucoma using a novel, non-contact imaging technique called Brillouin microscopy. The technology allows in vivo assessment of tissue stiffness without physical perturbation, potentially offering new insights into glaucoma risk and response to therapy.
The study includes two parts: a cross-sectional comparison between patients with normal- and high-tension glaucoma and healthy controls, and a longitudinal analysis of biomechanical changes following IOP-lowering treatment with either prostaglandin analogs or beta blockers.
The goal is to determine whether corneal biomechanics can serve as a biomarker for glaucoma susceptibility and progression, and to evaluate the feasibility of integrating Brillouin imaging into clinical glaucoma care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Tension Glaucoma | – | Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy, Drug: Beta Blocker, Device: Brillouin MicroscopyNewly diagnosed, treatment-naïve subjects with normal tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks. |
| High Tension Glaucoma | – | Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy, Drug: Beta Blocker, Device: Brillouin MicroscopyNewly diagnosed, treatment-naïve subjects with high tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks. |
| Control | – | Device: Brillouin MicroscopyAge-matched healthy control subjects with no history of glaucoma or IOP-lowering therapy. Brillouin imaging will be performed at a single time point for cross-sectional comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults aged 18 years and older with newly diagnosed, treatment-naïve primary open angle glaucoma (POAG), including both normal tension glaucoma (NTG) and high tension glaucoma (HTG), as well as age-matched healthy control subjects. Subjects must meet strict ophthalmic inclusion criteria and will be recruited from the University of Maryland Department of Ophthalmology and Visual Sciences and affiliated clinics. Exclusion criteria include significant ocular comorbidities, prior ocular surgery, systemic diseases that affect the eye, or prior glaucoma therapy.
Key inclusion criteria (10 listed)
- Age 18 years or older
- Diagnosis of primary open angle glaucoma (POAG) or no history of glaucoma (for controls)
- Open angle on gonioscopy (Shaffer grade 3 or 4)
- Best-corrected visual acuity of 20/25 or better
- Refractive error between +3.00 and -5.00 diopters
Key exclusion criteria (12 listed)
- Corneal abnormalities or conditions interfering with Brillouin or applanation tonometry
- Retinal diseases affecting RNFL (e.g., macular traction)
- History of ocular surgery or laser
- Diagnosis of diabetes
- History of uveitis
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 |
|---|---|---|
| Prostaglandin Analogue -Containing IOP-Lowering TherapyAlso: Latanoprost, Travaprost, BimatoprostSubjects with glaucoma may be prescribed prostaglandin analogs as part of their clinical care. This group will be observed longitudinally to assess changes in corneal biomechanics. | Drug | High Tension Glaucoma, Normal Tension Glaucoma |
| Beta BlockerAlso: TimololSubjects with glaucoma may be prescribed topical beta blockers as part of their clinical care. This group will be observed longitudinally to assess changes in corneal biomechanics. | Drug | High Tension Glaucoma, Normal Tension Glaucoma |
| Brillouin MicroscopyAlso: Brillouin ImagingBrillouin microscopy is a non-contact optical imaging method used to assess the biomechanical properties of the cornea in vivo with three-dimensional resolution. It will be used to evaluate corneal stiffness in all study subjects. | Device | Control, High Tension Glaucoma, Normal Tension Glaucoma |
Primary outcome
Change in Corneal Biomechanical Modulus
Time frame: Baseline, 3 weeks, and 6 weeks
Brillouin microscopy will be used to measure the corneal modulus of elasticity. The primary outcome is the change in corneal stiffness (Brillouin shift in MHz) across time points in subjects treated with prostaglandin analogs versus beta blockers, and between groups at baseline (NTG, HTG, controls).
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 10 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Summary-level results will be published and made publicly available per NIH policy.
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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.
Osamah Saeedi, MD principal investigator
University of Maryland, Baltimore
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 Glaucoma, run by University of Maryland, Baltimore 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 10 inclusion and 12 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 10 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 Osamah Saeedi, MD (16672141232, osaeedi@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Corneal Biomechanical Modulus (time frame: Baseline, 3 weeks, and 6 weeks). 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 Aug 2026.