Status:
WITHDRAWN
Ocular Hypertension And Yoga Study
Lead Sponsor:
Johns Hopkins University
Conditions:
Ocular Hypertension
Sleep Disturbance
Eligibility:
All Genders
18-90 years
Phase:
NA
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 bre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01446588
Start Date
June 1 2012
End Date
December 1 2012
Last Update
May 26 2014
Active Locations (1)
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1
Lions Vision and Research Rehabilitation
Baltimore, Maryland, United States, 21205