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Ocular Hypertension And Yoga Study (OHAYS)

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Johns Hopkins University

Status

Withdrawn

Conditions

Ocular Hypertension
Depression
Sleep Disturbance
Anxiety
Stress

Treatments

Behavioral: Yoga Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01446588
NA_00041019

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Yoga
Experimental group
Description:
Yoga group
Treatment:
Behavioral: Yoga Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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