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NCT Number: NCT06993597

Study of Corneal Biomechanics in Glaucoma Patients 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1757, United States

Location status: Recruiting

Location contact

Osamah Saeedi, MD

CONTACT

[email protected]

667-214-1232

Osamah Saeedi, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Latanoprost, Travaprost, Bimatoprost

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.

Other names: Timolol

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.

Other names: Brillouin Imaging

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Osamah Saeedi, MD

CONTACT

[email protected]

16672141232

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Development of Robust Corneal Biomechanical Biomarkers for Glaucoma Using Brillouin Microscopy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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