Ocular Hypertension And Yoga Study (OHAYS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01446588
Recruitment Status : Withdrawn (No Funding was acquired.)
First Posted : October 5, 2011
Last Update Posted : May 26, 2014
Information provided by (Responsible Party):
Pamela Jeter, Johns Hopkins University

Brief Summary:
The investigators aim to pilot test the efficacy of a yoga intervention designed specifically for individuals with ocular hypertension. The investigators would like to find out if a combination of breathing, postures and meditation may help to reduce intraocular pressure in the short term after each yoga session, and also long-term across an 8-week program. Subjects will participate in the yoga intervention sessions led by Dr. Pamela Jeter once a week at the investigators center, and will be asked to practice at home at least twice a week using a audio CD.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Sleep Disturbance Stress Anxiety Depression Behavioral: Yoga Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ocular Hypertension And Yoga Study
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Yoga
Yoga group
Behavioral: Yoga Intervention
Three yoga classes per week for 8 weeks.
Other Name: Yoga, Ashtanga

Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: Change in IOP from mean baseline at 8-weeks (end of yoga intervention period) ]
    Baseline IOP measures will be obtained at two visits prior to the intervention. At each weekly visit, we will obtain two series of IOP measures about one hour apart, similar to the sequence that will be used during the weekly yoga intervention, to estimate trends over an 8-week intervention period. Post-intervention IOP will be measured at a single session one week after the yoga intervention has ended, and at a follow-up visit one month after the yoga intervention. Subjects will be masked to the IOP results until they have completed the study.

Secondary Outcome Measures :
  1. Body Mass Index (BMI) (i.e. weight and height) [ Time Frame: Week 0 and week 8 ]
    Weight and height will be taken at baseline and Post-intervention.

  2. Blood pressure [ Time Frame: once a week for a total period of 11 weeks; then one additional measure 1 month later ]
    Systemic blood pressure (using a digital monitor with an automated cuff) and pulse rate will be measured at baseline, at the beginning and end of each yoga class, and the two post-intervention visits.

  3. Respiratory Rate (RR) [ Time Frame: Week 0 and Week 8 ]
    Respiratory rate will be measured twice for each participant to reduce within-session variability. It will be determined by counting the number of inhalations with a stethoscope for 30 seconds at rest and multiplying by two at baseline and post-intervention.

  4. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 0 and Week 8 ]
    The 19-item PSQI questionnaire will be used to gauge sleep quality over the past month. It includes both qualitative and quantitative aspects of sleep, and evaluates seven subscale dimensions of sleep quality. Measured at baseline (week 0) and immediately after the 8-week intervention.

  5. Perceived Stress Scale (PSS) [ Time Frame: Week 0 and Week 8 ]
    In order to subjectively assess the degree to which respondents have appraised situations in their life to be stressful on a given day, we will administer the 14 item PSS.

  6. Beck Anxiety Index (BAI) [ Time Frame: Week 0 and Week 8 ]
    The 21 item BAI will be used to measure the severity of an individual's anxiety over the past month.

  7. Beck Depression Index (BDI) [ Time Frame: Week 0 and Week 8 ]
    We will use the BDI to provide a measure of severity and type of depression.

  8. Positive and Negative Affect Schedule (PANAS) [ Time Frame: Week 0 and Week 8 ]
    The PANAS questionnaire consists of 10 positive affect items, which reflect one's level of pleasurable engagement with the environment, and 10 negative affect items, which are a general factor of subjective distress.

  9. Vision Test/Ocular Disease Catastrophizing Scale [ Time Frame: Week 0 and Week 8 ]
    The Catastrophizing Scale includes 20 questions that measure the individual's state and/or trait immediately after vision tests are performed.

  10. Philadelphia Mindfulness Scale (PHLMS) [ Time Frame: Week 0, Week 4 and Week 8 ]
    This 20-item scale assesses two components of mindfulness, acceptance and awareness. Total scores on both subscales range from 20 to 100, higher scores reflect greater mindfulness. The PHLMS will be collected at baseline, during week 4 and post- intervention.

  11. Exit Survey [ Time Frame: Week 8 ]
    Participants will complete a brief survey regarding their experience with the yoga class. The survey is comprised of open-ended and multiple-choice response items (e.g. treatment expectations).

  12. Practice Log [ Time Frame: once a week for a total period of 8 weeks ]
    Participants will be asked to complete a weekly log online to report the activity performed, time allotted to the practice and will be used to evaluate compliance.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18+
  • Diagnosis of ocular hypertension not requiring treatment of IOP
  • IOP in at least one eye ≥ 21 mm Hg
  • Normal Humphrey 24-2 or 30-2 visual fields for both eyes as determined by the patient's glaucoma specialist
  • Best-corrected visual acuity better than 20/40 in both eyes
  • Being healthy to the extent that participation in yoga therapy would not exacerbate any existing disease conditions;
  • Participants do not engage in athletic activity on a regular basis (i.e. are sedentary)
  • Able and willing to participate on a weekly basis for the 11-week intervention;
  • Informed consent

Exclusion Criteria:


  • Any visual field loss in either eye consistently detected with Humphrey Visual Field 30-2 or 24-2
  • Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment)
  • Previous intraocular surgery, except for uncomplicated extracapsular cataract extraction with posterior chamber-intraocular lens implant and no escape of vitreous to the anterior chamber, strabismus, cosmetic eyelid surgery, and radial keratotomy
  • Secondary causes of elevated IOP, including ocular and systemic corticosteroid use
  • Angle closure glaucoma or anatomically narrow angles—75% of the circumference of the angle must be grade 2 or more by Shaffer criteria
  • Pigmentary glaucoma
  • Congenital glaucoma
  • Other diseases that cause visual field loss or optic disc abnormalities
  • Difference in cup-disc ratios (horizontal by contour) between the two eyes of >0.2
  • Background diabetic retinopathy, defined as at least 1 microaneurysm seen on ophthalmoscopy with dilated pupil, or any retinal hemorrhage


  • Abdominal Aneurism
  • Cancer, metastatic
  • Fibromyalgia, severe
  • Inflammatory autoimmune diseases (e.g. Lupus, Rheumatoid arthritis, Scleroderma)
  • Other disabling chronic conditions (e.g., disabling heart or lung disease, diabetic neuropathy, receiving treatment for hepatitis)
  • A life-threatening or debilitating disease


  • Seeking/receiving compensation/litigation for back pain
  • Previous back surgery, ever
  • Low back pain that has lasted > 1 month
  • Severe pain when bending or twisting spine
  • Sciatica
  • Discitis or Disk disease
  • Fracture of vertebra
  • Infectious cause of back pain
  • Scoliosis, severe or progressive
  • Spinal stenosis
  • Spondylolisthesis
  • Anklyosing spondylitis


  • Deafness or severe hearing problems
  • Psychoses, major
  • Schedules do not permit participation in classes or home practice (including planning to move out of town)
  • Paralysis
  • Unable to walk two city blocks
  • Unable to get up and down from floor
  • Lack of transportation
  • Any planned surgery during the upcoming study period


  • Pregnant or nursing women as determined by patient self-report
  • Use of psychotropic medication
  • Consumption of more than three alcoholic beverages per day
  • Smoking more than 10 cigarettes per day
  • Recent substance abuse


  • Dementia
  • Long or short-term memory loss
  • Unable to read or speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01446588

United States, Maryland
Lions Vision and Research Rehabilitation
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Ava Bittner, OD, PhD Johns Hopkins University

Responsible Party: Pamela Jeter, Postdoctoral Research Fellow, Johns Hopkins University Identifier: NCT01446588     History of Changes
Other Study ID Numbers: NA_00041019
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Ocular Hypertension
Sleep Wake Disorders
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms