Study of Corneal Biomechanics in Glaucoma Patients Using Brillouin Microscopy

NCT06993597 — Recruiting, 60 participants, University of Maryland, Baltimore

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Development of Robust Corneal Biomechanical Biomarkers for Glaucoma Using Brillouin Microscopy

RegistryNCT06993597
StatusRecruiting
Study typeObservational
Enrollment60 (Estimated)
SponsorUniversity of Maryland, Baltimore (Other); collaborators: National Eye Institute (NEI)
ConditionsGlaucoma
InterventionsProstaglandin Analogue -Containing IOP-Lowering Therapy, Beta Blocker, Brillouin Microscopy (Drug, device)
Datesstart 2025-09-01, primary completion 2027-03-01 (estimated), completion 2027-06-01 (estimated), first posted 2025-05-29, last updated 2026-08-10
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Glaucoma All trials of Prostaglandin Analogue -Containing IOP-Lowering Therapy All trials of Beta Blocker

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Normal Tension GlaucomaDrug: 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 GlaucomaDrug: 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.
ControlDevice: 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.
  • Prostaglandin Analogue -Containing IOP-Lowering Therapy (Drug), also known as 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 Blocker (Drug), also known as 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 Microscopy (Device), also known as 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.

+Outcome measures

Primary outcomes

  • Change in Corneal Biomechanical Modulus [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).

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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:

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

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

+Locations (1)

FacilityCityCountryStatus
University of Maryland School of MedicineBaltimore, MarylandUnited StatesRecruiting

+Investigators

+Funding

NIH grants: R21EY035483