Study of Corneal Biomechanics in Glaucoma Patients Using Brillouin Microscopy

NCT06993597 | Recruiting DMC FDA Drug

• 2 other identifiers: HP-00110432R21EY035483
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

glaucoma; cornea; biomechanics

Outcome Measures

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).

  Baseline, 3 weeks, and 6 weeks

Study Arms (3)

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

Prostaglandin Analogue -Containing IOP-Lowering Therapy DRUG

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

High Tension Glaucoma; Normal Tension Glaucoma

Beta Blocker DRUG

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

High Tension Glaucoma; Normal Tension Glaucoma

Brillouin Microscopy DEVICE

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

Control; High Tension Glaucoma; Normal Tension Glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1757, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma; Corneal Diseases

Interventions

Latanoprost; Bimatoprost; Adrenergic beta-Antagonists; Timolol

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Organic Chemicals; Cloprostenol; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Osamah Saeedi, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osamah Saeedi, MD

CONTACT

16672141232; osaeedi@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)