Recruiting

Brillouin Microscopy

Sponsor:

University of Maryland, Baltimore

Code:

NCT06993597

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Prostaglandin Analogue -Containing IOP-Lowering Therapy

Beta Blocker

Brillouin Microscopy

Study Details

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

Study ID

NCT06993597

Start date

Sep 1, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Prostaglandin Analogue -Containing IOP-Lowering Therapy

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

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

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.

Primary outcome measure

  • Change in Corneal Biomechanical Modulus [ Time Frame: Baseline, 3 weeks, and 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201-1757

Contacts

Principal Investigator:

Osamah Saeedi, MD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • glaucoma
  • cornea
  • biomechanics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-08-10.