Clinical trial NCT01446588: Ocular Hypertension And Yoga Study
Official title: Ocular Hypertension And Yoga Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ocular Hypertension
Sleep Disturbance
Stress
Anxiety
Depression
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

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
* 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

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: Change in IOP from mean baseline at 8-weeks (end of yoga intervention period)
Secondary outcomes:
measure: Body Mass Index (BMI) (i.e. weight and height)
timeFrame: Week 0 and week 8
measure: Blood pressure
timeFrame: once a week for a total period of 11 weeks; then one additional measure 1 month later
measure: Respiratory Rate (RR)
timeFrame: Week 0 and Week 8
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 0 and Week 8
measure: Perceived Stress Scale (PSS)
timeFrame: Week 0 and Week 8
measure: Beck Anxiety Index (BAI)
timeFrame: Week 0 and Week 8
measure: Beck Depression Index (BDI)
timeFrame: Week 0 and Week 8
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Week 0 and Week 8
measure: Vision Test/Ocular Disease Catastrophizing Scale
timeFrame: Week 0 and Week 8
measure: Philadelphia Mindfulness Scale (PHLMS)
timeFrame: Week 0, Week 4 and Week 8
measure: Exit Survey
timeFrame: Week 8
measure: Practice Log
timeFrame: once a week for a total period of 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Lions Vision and Research Rehabilitation
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ava Bittner, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: