ClinicalTrials.gg
RecruitingNCT06993597Updated Aug 10, 2026

Study of Corneal Biomechanics in Glaucoma Patients Using Brillouin Microscopy

An observational study in Glaucoma, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University of Maryland, Baltimore · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 490 studies in Glaucoma with a site in United States — 77 open to participants now, 96 under way, 5 of them phase 3. Glaucoma · United States.

Planned enrollment
72nd of 110
60 · median 100
Started
2025
with 28 others
Observational
110 of 490
19 open now
Primary completion
2027-03
later than 38 of 95 live
Registered
445th of 490
by date

Among the 490 studies in Glaucoma with a site in United States, this one is the 72nd largest by planned enrollment of the 110 observational ones that give a count, is one of 29 that started in 2025, is one of 110 observational ones, reaches primary completion later than 38 of the 95 other live ones, and was the 445th registered.

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

Browse Glaucoma studies →

Open to participants now

77 of the 490 studies in Glaucoma with a site in United States are open now. Recruiting first, the newest first:

72 more — sign in →

All 77 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 156 Glaucoma studies recruiting now, 114 (73%) set no upper age limit and 9 (6%) stop at 75 or younger; 13 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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 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.

03

Conditions studied

  • Glaucoma

Keywords

  • glaucoma
  • cornea
  • biomechanics
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- 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

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

Exclusion criteria

Exclusion Criteria:

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 use

Neurodegenerative or systemic diseases (e.g., multiple sclerosis, Alzheimer's, Parkinson's, schizophrenia)

Unreliable visual fields

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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    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.

    Device: Brillouin Microscopy

Interventions

  • 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.

    Also known as: Latanoprost, Travaprost, Bimatoprost

  • 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.

    Also known as: Timolol

  • DeviceBrillouin Microscopy

    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.

    Also known as: Brillouin Imaging

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, 3 weeks, and 6 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared. Summary-level results will be published and made publicly available per NIH policy.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Mar 2027, 18 months after the start.

Of 110 non-industry observational studies under Glaucoma, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 208. This study's planned 18 months is below that.

Counting every sponsor, half of 134 studies reached it within 31 months; a quarter within 12 and three quarters within 208.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2025
First posted
May 29, 2025
StartActual
Sep 1, 2025
Primary completionEst.
Mar 2027
CompletionEst.
Jun 2027
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06993597
Responsible party
Sponsor
First posted
May 29, 2025
Start date
Sep 1, 2025
Primary completion
Mar 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Osamah Saeedi, MD
Contact
osaeedi@som.umaryland.edu
16672141232
Osamah Saeedi, MD
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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