Glaucoma, Open-AngleNCT03267862
Scleral Response to Intraocular Pressure (IOP)
An observational study of Glaucoma, Open-Angle, run by Johns Hopkins University.
Trial summary
The study evaluated changes in the depth of the lamina cribrosa at different eye pressures. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Glaucoma, Open-Angle
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2014to 29 Aug 2017
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: glaucoma patients presenting for routine care
Who may be able to join
- glaucoma patients
Who cannot join
- non-glaucoma patients
About this study
The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.
Read the detailed description
Participants were glaucoma patients who during routine care were observed at different eye pressures. Images taken with an optical device that is routinely used in such patients were analysed.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- there was no intervention
- 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.
there was no interventionOther
patients were observed during routine care on separate times when their eye pressure was different on one day from another.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior lamina cribrosa depth change
Position of anterior lamina observed by optical coherence tomography (OCT) imaging. Measured in micrometers (um).
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 start17 Sep 2014
- Primary completion29 Aug 2017
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267862
- Sponsor's protocol ID
- NA_00090957
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: deidentified study data could be shared at this time
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleral Response to Intraocular Pressure (IOP)
- ClinicalTrials.gov ID
- NCT03267862
- Acronym / sponsor ID
- NA_00090957
- Conditions
- Glaucoma, Open-Angle
- Keywords
- biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 17 Sep 2014 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 29 Aug 2017 (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.
The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.
Detailed description
Participants were glaucoma patients who during routine care were observed at different eye pressures. Images taken with an optical device that is routinely used in such patients were analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma patients presenting for routine care
Key inclusion criteria (1 listed)
- glaucoma patients
Key exclusion criteria (1 listed)
- non-glaucoma patients
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 |
|---|---|---|
| there was no interventionpatients were observed during routine care on separate times when their eye pressure was different on one day from another. | Other | – |
Primary outcome
Anterior lamina cribrosa depth change
Time frame: Up to 2 months
Position of anterior lamina observed by optical coherence tomography (OCT) imaging. Measured in micrometers (um).
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 30 Aug 2017.
- Individual participant dataSharing planned: Undecided. deidentified study data could be shared at this time
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle, run by Johns Hopkins University.
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 1 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Anterior lamina cribrosa depth change (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?
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 30 Aug 2017.