Development of Robust Corneal Biomechanical Biomarkers for Glaucoma Using Brillouin Microscopy
| Registry | NCT06993597 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 60 (Estimated) |
| Sponsor | University of Maryland, Baltimore (Other); collaborators: National Eye Institute (NEI) |
| Conditions | Glaucoma |
| Interventions | Prostaglandin Analogue -Containing IOP-Lowering Therapy, Beta Blocker, Brillouin Microscopy (Drug, device) |
| Dates | start 2025-09-01, primary completion 2027-03-01 (estimated), completion 2027-06-01 (estimated), first posted 2025-05-29, last updated 2026-08-10 |
| Locations | 1 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Normal Tension Glaucoma | Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy; Drug: Beta Blocker; Device: Brillouin Microscopy | 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. | |
| High Tension Glaucoma | Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy; Drug: Beta Blocker; Device: Brillouin Microscopy | 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. | |
| Control | Device: Brillouin Microscopy | 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. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Maryland School of Medicine | Baltimore, Maryland | United States | Recruiting |
NIH grants: R21EY035483