GlaucomaNCT01915680
Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions
An observational study of Glaucoma and Intraocular Pressure, run by Robert Ritch, MD, LLC. at 1 site in United States.
Trial summary
The purpose of the study is to investigate the IOP difference between normal and glaucomatous eyes using standard ophthalmic tonometry devices while subjects are performing different standard yoga asanas. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Intraocular Pressure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2013
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Glaucoma Practice and Yoga Studios
Who may be able to join
- Glaucoma or healthy control
- Practice yoga
- 18-80 years old
- Practice Yoga for a minimum of 12 months
Who cannot join
- Healthy subjects do not have normal ophthalmic exam
- Cannot maintain yoga positions
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaucoma Associates of New York
New York, New York, 10003
About this study
The purpose of the study is to investigate the IOP difference between normal and glaucomatous eyes using standard ophthalmic tonometry devices while subjects are performing different standard yoga asanas. The IOP of participants will be measured prior, immediately at start of the asana, 2 minutes into the asana, and immediately after assuming a sitting position. The patient will wait 10 minutes and a final IOP will be taken. Four standard yoga asanas will be tested.
- Conditions
- Glaucoma, Intraocular Pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure
Measured: Change from Baseline, Immediate, 2 Minutes, Post, 10 min Post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Ritch, MD, LLC.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Ritch, MD, Robert Ritch, MD, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915680
- Sponsor's protocol ID
- NYGRI Yoga Study 13.04
- Status last verified
- Dec 2013
- First submitted
- 12 Jul 2013
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jasien JV, Jonas JB, de Moraes CG, Ritch R. Intraocular Pressure Rise in Subjects with and without Glaucoma during Four Common Yoga Positions. PLoS One. 2015 Dec 23;10(12):e0144505. doi: 10.1371/journal.pone.0144505. eCollection 2015.
PubMed 26698309
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions
- ClinicalTrials.gov ID
- NCT01915680
- Acronym / sponsor ID
- NYGRI Yoga Study 13.04
- Conditions
- Glaucoma, Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Robert Ritch, MD, LLC.University, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Aug 2013 (estimated)
- 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 purpose of the study is to investigate the IOP difference between normal and glaucomatous eyes using standard ophthalmic tonometry devices while subjects are performing different standard yoga asanas. The IOP of participants will be measured prior, immediately at start of the asana, 2 minutes into the asana, and immediately after assuming a sitting position. The patient will wait 10 minutes and a final IOP will be taken. Four standard yoga asanas will be tested.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma Practice and Yoga Studios
Key inclusion criteria (4 listed)
- Glaucoma or healthy control
- Practice yoga
- 18-80 years old
- Practice Yoga for a minimum of 12 months
Key exclusion criteria (2 listed)
- Healthy subjects do not have normal ophthalmic exam
- Cannot maintain yoga positions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Intraocular Pressure
Time frame: Change from Baseline, Immediate, 2 Minutes, Post, 10 min Post
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 19 Oct 2018.
- Derived from this study: PubMed 26698309Jasien JV, Jonas JB, de Moraes CG, Ritch R. Intraocular Pressure Rise in Subjects with and without Glaucoma during Four Common Yoga Positions. PLoS One. 2015 Dec 23;10(12):e0144505. doi: 10.1371/journal.pone.0144505. eCollection 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Intraocular Pressure, run by Robert Ritch, MD, LLC. 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 4 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 19 Oct 2018. 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 Intraocular Pressure (time frame: Change from Baseline, Immediate, 2 Minutes, Post, 10 min Post). 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 NCT01915680, which also lists 1 linked publication.
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 19 Oct 2018.