Study of Corneal Biomechanics in Glaucoma Patients Using Brillouin Microscopy

Официальное название

Development of Robust Corneal Biomechanical Biomarkers for Glaucoma Using Brillouin Microscopy

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Устройство 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.

Первичные конечные точки

• Change in Corneal Biomechanical Modulus [Срок оценки: Baseline, 3 weeks, and 6 weeks]

Критерии участия

Критерии включения

\- 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• University of Maryland School of Medicine — Baltimore

Идентификаторы

NCT: NCT06993597 · HP-00110432 · R21EY035483

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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