Intraocular Pressure Fluctuation in Patients With Glaucom... | NCT01915680

Studies
Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions

NCT01915680

Sponsor

Robert Ritch, MD, LLC.

Status

Completed

Last Update Posted

Oct 19, 2018Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Glaucoma
Intraocular Pressure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jul 12, 2013

First Submission Date that Met QC Criteria

Aug 2, 2013

First Posted Date

Aug 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2018

Last Update Posted Date

Oct 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Ritch, MD, Associate Professor of Ophtalmology, Robert Ritch, MD, LLC.Principal Investigator

Lead Sponsor

Robert Ritch, MD, LLC.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Intraocular Pressure		Change from Baseline, Immediate, 2 Minutes, Post, 10 min Post

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Glaucoma or healthy control
Practice yoga
18-80 years old
Practice Yoga for a minimum of 12 months

Exclusion Criteria:

Healthy subjects do not have normal ophthalmic exam
Cannot maintain yoga positions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Glaucoma Practice and Yoga Studios

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaucoma Associates of New York		New York	New York	10003	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26698309	Derived	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.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases