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NCT06240312 Clinical Trial

Optic Nerve Head Strain as Biomarker for Glaucoma

Glaucoma, Open-Angle Clinical Trial

Official title:
Optic Nerve Head Strain as Biomarker for Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06240312
Other study ID # IRB00431247
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date January 31, 2028

Study information
Verified date April 2024
Source Johns Hopkins University
Contact Harry A Quigley
Phone 4437427079
Email hquigley@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 130
Est. completion date January 31, 2028
Est. primary completion date January 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Existing glaucoma patients of Johns Hopkins Exclusion Criteria: - Inability to perform imaging - illiterate - hearing impaired - non-English speakers

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Images of eye at 2 eye pressures
subject images of the eye's optic nerve head are studied

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins University National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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