Ocular HypertensionOHAYSNCT01446588
Ocular Hypertension And Yoga Study
A study testing Yoga Intervention in people with Ocular Hypertension and Sleep Disturbance, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Hypertension, Sleep Disturbance, Stress
- What is being tested?
- Yoga Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2012
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- VISUAL HISTORY
- 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
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- 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
- SPECIFIC SYSTEMIC DISEASES/CONDITIONS
- 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
- BACK PROBLEM OF COMPLICATED NATURE, INCLUDING MEDICO-LEGAL ISSUES
- 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
- CONDITIONS THAT MIGHT MAKE IT DIFFICULT TO ATTEND THE CLASSES OR PRACTICE AT HOME.
- 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
- CONDITIONS/CIRCUMSTANCES THAT MIGHT CONFOUND TREATMENT EFFECTS OR INTERPRETATION OF DATA
- 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
- CONDITION WOULD MAKE IT DIFFICULT TO PROVIDE FULLY INFORMED CONSENT
- Dementia
- Long or short-term memory loss
- Unable to read or speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Lions Vision and Research Rehabilitation
Baltimore, Maryland, 21205
About this study
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.
- Conditions
- Ocular Hypertension, Sleep Disturbance, Stress, Anxiety, Depression
- Being tested
- Yoga Intervention
- Medical subject headings
- Ocular Hypertension, Parasomnias, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionBehavioural
Also called Yoga, Ashtanga
Three yoga classes per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Yoga group Receives: Behavioral: Yoga Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
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.
Measured: Change in IOP from mean baseline at 8-weeks (end of yoga intervention period)
Secondary outcomes (12)
Body Mass Index (BMI) (i.e. weight and height)
Weight and height will be taken at baseline and Post-intervention.
Measured: Week 0 and week 8
Blood pressure
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.
Measured: once a week for a total period of 11 weeks; then one additional measure 1 month later
Respiratory Rate (RR)
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.
Measured: Week 0 and Week 8
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Week 0 and Week 8
Perceived Stress Scale (PSS)
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.
Measured: Week 0 and Week 8
Beck Anxiety Index (BAI)
The 21 item BAI will be used to measure the severity of an individual's anxiety over the past month.
Measured: Week 0 and Week 8
Beck Depression Index (BDI)
We will use the BDI to provide a measure of severity and type of depression.
Measured: Week 0 and Week 8
Positive and Negative Affect Schedule (PANAS)
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.
Measured: Week 0 and Week 8
Vision Test/Ocular Disease Catastrophizing Scale
The Catastrophizing Scale includes 20 questions that measure the individual's state and/or trait immediately after vision tests are performed.
Measured: Week 0 and Week 8
Philadelphia Mindfulness Scale (PHLMS)
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.
Measured: Week 0, Week 4 and Week 8
Exit Survey
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).
Measured: Week 8
Practice Log
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.
Measured: once a week for a total period of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: No Funding was acquired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Jeter, Johns Hopkins University
- Investigators
- Ava Bittner, OD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446588
- Sponsor's protocol ID
- NA_00041019
- Acronym
- OHAYS
- Status last verified
- May 2014
- First submitted
- 20 Sep 2011
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Hypertension And Yoga Study
- ClinicalTrials.gov ID
- NCT01446588
- Acronym / sponsor ID
- OHAYS / NA_00041019
- Conditions
- Ocular Hypertension, Sleep Disturbance, Stress, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Funding was acquired.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Oct 2011 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga InterventionYoga group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (50 listed)
- VISUAL HISTORY
- 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
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 |
|---|---|---|
| Yoga InterventionAlso: Yoga, AshtangaThree yoga classes per week for 8 weeks. | Behavioural | Yoga |
Primary outcome
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.
12 secondary outcomes
Body Mass Index (BMI) (i.e. weight and height)
Time frame: Week 0 and week 8
Blood pressure
Time frame: once a week for a total period of 11 weeks; then one additional measure 1 month later
Respiratory Rate (RR)
Time frame: Week 0 and Week 8
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 0 and Week 8
Perceived Stress Scale (PSS)
Time frame: Week 0 and Week 8
Beck Anxiety Index (BAI)
Time frame: Week 0 and Week 8
Beck Depression Index (BDI)
Time frame: Week 0 and Week 8
Positive and Negative Affect Schedule (PANAS)
Time frame: Week 0 and Week 8
Vision Test/Ocular Disease Catastrophizing Scale
Time frame: Week 0 and Week 8
Philadelphia Mindfulness Scale (PHLMS)
Time frame: Week 0, Week 4 and Week 8
Exit Survey
Time frame: Week 8
Practice Log
Time frame: once a week for a total period of 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
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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.
Ava Bittner, OD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Intervention in people with Ocular Hypertension and Sleep Disturbance, 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 9 inclusion and 50 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: withdrawn, as of the sponsor's last update on 26 May 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Intraocular Pressure (IOP) (time frame: Change in IOP from mean baseline at 8-weeks (end of yoga intervention period)). 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 26 May 2014; AzTrials last refreshed its copy on 26 Oct 2026.