NCT06240312

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jul 2024Jan 2028

First Submitted

Initial submission to the registry

January 26, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

3.6 years

First QC Date

January 26, 2024

Last Update Submit

June 11, 2025

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

All subjects

OTHER

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

Device: Images of eye at 2 eye pressures

Interventions

Images of eye at 2 eye pressuresDEVICE

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

All subjects

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Existing glaucoma patients of Johns Hopkins

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Harry Quigley

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry A Quigley

CONTACT

4109556051hquigley@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 5, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)