Glaucoma, Open-AngleNCT03267849
Lamina Cribrosa Depth Change With Change in Eye Pressure
A study testing wearing swimming goggles or having laser suturelysis in people with Glaucoma, Open-Angle, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a study of the compliance of the lamina cribrosa with change in eye pressure. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- wearing swimming goggles or having laser suturelysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- persons who consent to drink water and be imaged
Who cannot join
- non-consenting persons
- those who cannot be imaged
Trial locations and contacts
1 site in 1 country.
About this study
This is a study of the compliance of the lamina cribrosa with change in eye pressure.
Read the 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
- Conditions
- Glaucoma, Open-Angle
- Being tested
- wearing swimming goggles or having laser suturelysis
- Keywords
- biomarker
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearing swimming goggles or having laser suturelysisOther
Two images will be compared in each subject at two different eye pressures with the higher pressure having been produced by the interventions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: wearing swimming goggles or having laser suturelysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Jul 2017
- Primary completion1 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Topcon Corporation
- Responsible party
- Sponsor
- Investigators
- Harry A Quigley, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267849
- Sponsor's protocol ID
- IRB00133667
- Status last verified
- Oct 2024
- First submitted
- 29 Aug 2017
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified information (imaging data) will be shared after initial publication
Publications
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.
PubMed 39630437Czerpak 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.
PubMed 38272391Hannay 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.
PubMed 37645852Czerpak 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.
PubMed 35863747
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lamina Cribrosa Depth Change With Change in Eye Pressure
- ClinicalTrials.gov ID
- NCT03267849
- Acronym / sponsor ID
- IRB00133667
- Conditions
- Glaucoma, Open-Angle
- Keywords
- biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Topcon Corporation
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| persons drinking water | Experimental | Other: wearing swimming goggles or having laser suturelysisall 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 |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persons who consent to drink water and be imaged
Key exclusion criteria (2 listed)
- non-consenting persons
- those who cannot be imaged
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearing swimming goggles or having laser suturelysisTwo images will be compared in each subject at two different eye pressures with the higher pressure having been produced by the interventions | Other | persons drinking water |
Primary outcome
Change in anterior lamina cribrosa depth
Time frame: Up to 2 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39630437Czerpak 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.
- Derived from this study: PubMed 38272391Czerpak 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.
- Derived from this study: PubMed 37645852Hannay 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.
- Derived from this study: PubMed 35863747Czerpak 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.
- Individual participant dataSharing planned: Yes. deidentified information (imaging data) will be shared after initial publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry A Quigley, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearing swimming goggles or having laser suturelysis in people with Glaucoma, Open-Angle, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anterior lamina cribrosa depth (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267849, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.