Optic Nerve Head Strain as Biomarker for Glaucoma

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: Recruiting
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: Images of eye at 2 eye pressures

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

• Study Contact: Name: Harry A Quigley; Phone Number: 4109556051; Email: hquigley@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Contact: Harry A Quigley, MD; Phone Number: 410-955-6052; Email: hquigley@jhmi.edu
      • Contact: Solanyi Moronta, AB; Phone Number: 4109556051; Email: smoront1@jhmi.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Strains measured at baseline are tested for association with glaucoma course	Approximately 3 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Harry Quigley, Johns Hopkins School of Medicine

Study record dates

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 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• 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