Lamina Cribrosa Depth Change With Change in Eye Pressure

NCT03267849 | Completed

• 1 other identifier: IRB00133667
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma, Open-Angle

Keywords

biomarker

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 2 months

Study Arms (1)

persons drinking water

EXPERIMENTAL

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

Other: wearing swimming goggles or having laser suturelysis

Interventions

wearing swimming goggles or having laser suturelysis OTHER

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

persons drinking water

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persons who consent to drink water and be imaged

You may not qualify if:

• non-consenting persons
• those who cannot be imaged

Sponsors & Collaborators

• Johns Hopkins University: lead
• Topcon Corporation: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• Czerpak CA, Kashaf MS, Zimmerman BK, Mirville R, Gasquet NC, Quigley HA, Nguyen TD. The Strain Response to Intraocular Pressure Increase in the Lamina Cribrosa of Control Subjects and Glaucoma Patients. Transl Vis Sci Technol. 2024 Dec 2;13(12):7. doi: 10.1167/tvst.13.12.7.

  PMID: 39630437 DERIVED

• Czerpak CA, Quigley HA, Nguyen TD. Long-term Remodeling Response in the Lamina Cribrosa Years after Intraocular Pressure Lowering by Suturelysis after Trabeculectomy. Ophthalmol Glaucoma. 2024 May-Jun;7(3):298-307. doi: 10.1016/j.ogla.2024.01.003. Epub 2024 Jan 24.

  PMID: 38272391 DERIVED

• Hannay V, Czerpak CA, Quigley HA, Nguyen TD. A noninvasive clinical method to measure in vivo mechanical strains of the lamina cribrosa by optical coherence tomography. medRxiv [Preprint]. 2023 Aug 16:2023.08.14.23294082. doi: 10.1101/2023.08.14.23294082.

  PMID: 37645852 DERIVED

• 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.

  PMID: 35863747 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Harry A Quigley, MD

  Professor

  PRINCIPAL INVESTIGATOR

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: August 29, 2017
• First Posted: August 30, 2017
• Study Start: July 1, 2017
• Primary Completion: October 1, 2024
• Study Completion: October 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: after initial publication, indefinitely
• Access Criteria: no restrictions

Locations

US (1)