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Lamina Cribrosa Depth Change With Change in Eye Pressure

Primary Purpose

Glaucoma, Open-Angle

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

wearing swimming goggles or having laser suturelysis

About this trial

This is an interventional diagnostic trial for Glaucoma, Open-Angle focused on measuring biomarker

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

persons who consent to drink water and be imaged

Exclusion Criteria:

non-consenting persons
those who cannot be imaged

Sites / Locations

Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

persons drinking water

Arm Description

all persons in the study will have images of the eye at baseline eye pressure, then the intervention will be to drink 2 bottles of water to increase eye pressure or decrease eye pressure, then will have images taken a second time

Outcomes

Primary Outcome Measures

Change in anterior lamina cribrosa depth

OCT position of lamina measured at 2 eye pressures. Data will be calculated as change in parameters of interest per mm Hg change in eye pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT03267849

First Posted

August 29, 2017

Last Updated

July 3, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT03267849

Brief Title

Lamina Cribrosa Depth Change With Change in Eye Pressure

Official Title

Lamina Cribrosa Depth Change With Change in Eye Pressure

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

July 1, 2025 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a study of the compliance of the lamina cribrosa with change in eye pressure.

Detailed Description

Glaucoma patients and control subjects will have their internal eye structure (lamina cribrosa) imaged by optical coherence tomography (OCT) standard images at two different eye pressures. In some participants, the eye pressure will be changed by one of two interventions, wearing goggles or having laser suturelysis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle

Keywords

biomarker

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

persons drinking water

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

wearing swimming goggles or having laser suturelysis

Intervention Description

Two images will be compared in each subject at two different eye pressures with the higher pressure having been produced by the interventions

Primary Outcome Measure Information:

Title

Change in anterior lamina cribrosa depth

Description

OCT position of lamina measured at 2 eye pressures. Data will be calculated as change in parameters of interest per mm Hg change in eye pressure

Time Frame

Up to 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: persons who consent to drink water and be imaged Exclusion Criteria: non-consenting persons those who cannot be imaged

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Harry A Quigley, MD

Phone

4109552777

hquigley@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harry A Quigley, MD

Organizational Affiliation

Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harry A Quigley, MD

Phone

410-955-2777

hquigley@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Pat Tracey, AB

Phone

4109552769

ptracey@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

deidentified information (imaging data) will be shared after initial publication

IPD Sharing Time Frame

after initial publication, indefinitely

IPD Sharing Access Criteria

no restrictions

Citations:

PubMed Identifier

35863747

Citation

Czerpak CA, Kashaf MS, Zimmerman BK, Quigley HA, Nguyen TD. The Strain Response to Intraocular Pressure Decrease in the Lamina Cribrosa of Patients with Glaucoma. Ophthalmol Glaucoma. 2023 Jan-Feb;6(1):11-22. doi: 10.1016/j.ogla.2022.07.005. Epub 2022 Jul 19.

Results Reference

derived

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Lamina Cribrosa Depth Change With Change in Eye Pressure

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