Optic Nerve Head Strain as Biomarker for Glaucoma

June 9, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Existing glaucoma patients of Johns Hopkins

Exclusion Criteria:

  • Inability to perform imaging
  • illiterate
  • hearing impaired
  • non-English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All subjects
Each subject will be imaged at two different times and eye pressures
Device: Images of eye at 2 eye pressures
subject images of the eye's optic nerve head are studied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve head mechanical strain compared to visual field change over time
Time Frame: Approximately 3 years
Strains measured at baseline are tested for association with glaucoma course
Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Harry Quigley, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00431247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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