Optic Nerve Head Strain in Non-glaucoma Subjects

July 10, 2026 updated by: Johns Hopkins University
Persons who do not have glaucoma will have pictures taken of the optic nerve with a standard camera before and 2 weeks after starting to take a daily glaucoma eye drop to lower eye pressure. These data will be used to compare to the same procedure performed with glaucoma patients to study how glaucoma injures the eye.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The present proposal seeks to measure biomechanical strains in age-matched control subjects who do not have Open-angle Glaucoma (OAG), using the same non-invasive imaging methods as in the above programs. This is necessary as even undamaged OAG eyes may have different biomechanical properties at baseline than do non-OAG eyes. While there are some limited methods to test strains in control eyes, to compare normal to OAG responses robustly, the same methods of changing intra-ocular pressure (IOP) must be applied-namely to lower IOP by delivery of FDA-approved agent, latanoprost, as has been done in the investigator's OAG subjects. The method of measuring strain requires images taken at two different IOP levels.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Harry A Quigley, MD

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:

  • Adults who have no history of OAG
  • Have an ocular examination by a glaucoma specialist with no indications of OAG
  • Have normal optical coherence tomography findings in the retinal nerve fiber layer.
  • Over age 30 will be included from
  • Both sexes
  • All ethnic groups.
  • Optic neuropathy.
  • Both suspects and those with glaucoma damage will be included.
  • When both eyes meet inclusion and exclusion criteria, both eyes will be included in the study and statistical methods will be used to account for correlations between eyes within the same individual.

Exclusion Criteria:

  • in whom sitting in an upright position is impossible due to physical disability
  • with ocular media opacity, corneal scarring, cataract or vitreous hemorrhage, that does not allow adequate imaging resolution.
  • in whom keeping the eyes open during the imaging procedure is not possible or uncomfortable.
  • who cannot perform home tonometry accurately at certification
  • who do not have reliable clinical Optical Coherence Tomography (OCT) testing.
  • with any form of glaucoma
  • with high myopia defined as refractive error > -8
  • with past keratorefractive surgery, corneal dystrophy, or corneal ectasia that would make self-tonometry measurements difficult to interpret
  • inability to understand English or with a language or hearing impairment

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
Experimental: Study group
The participants will take an approved glaucoma eye drop, latanoprost, for less than one month, with pictures of the eyes at baseline and while taking the drop.
Drug: Latanoprost (0.005%)
Participants take the eye drop daily for less than one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve head strain
Time Frame: up to 1 month
Biomechanical strain measured by optical coherence tomography
up to 1 month

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, MD, Johns Hopkins University

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)

June 24, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00541877
  • R01EY036042 (U.S. NIH Grant/Contract)

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

No

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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