Optic Nerve Head Strain as Biomarker for Glaucoma

NCT ID: NCT06240312

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2028-01-31

Brief Summary

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The investigators will test the hypothesis that images of the optic nerve head taken a 2 different eye pressures will yield strain estimates that are predictive of the course of glaucoma.

Detailed Description

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Existing glaucoma patients and suitable control adults will be imaged with an FDA-approved optical coherence tomography instrument. Those who are imaged at 2 different eye pressures will generate biomechanical strain estimates. These will be compared to visual field and retinal nerve fiber layer measurements over time. The investigators expect that baseline strain and their changes over time will be associated with progression rate of glaucoma damage, providing a biomarker for susceptibility.

Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All subjects

Each subject will be imaged at two different times and eye pressures

Group Type OTHER

Images of eye at 2 eye pressures

Intervention Type DEVICE

subject images of the eye's optic nerve head are studied

Interventions

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Images of eye at 2 eye pressures

subject images of the eye's optic nerve head are studied

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Existing glaucoma patients of Johns Hopkins

Exclusion Criteria

* Inability to perform imaging
* illiterate
* hearing impaired
* non-English speakers
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry Quigley

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Harry A Quigley

Role: CONTACT

4109556051

Facility Contacts

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Harry A Quigley, MD

Role: primary

410-955-6052

Solanyi Moronta, AB

Role: backup

4109556051

Other Identifiers

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IRB00431247

Identifier Type: -

Identifier Source: org_study_id

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