Ocular Hypertension And Yoga Study

NCT01446588 | Withdrawn

• 1 other identifier: NA_00041019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Hypertension; Sleep Disturbance; Stress; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Week 0 and week 8

• Blood pressure

  once a week for a total period of 11 weeks; then one additional measure 1 month later

• Respiratory Rate (RR)

  Week 0 and Week 8

• Pittsburgh Sleep Quality Index (PSQI)

  Week 0 and Week 8

• Perceived Stress Scale (PSS)

  Week 0 and Week 8

Study Arms (1)

Yoga

EXPERIMENTAL

Yoga group

Behavioral: Yoga Intervention

Interventions

Yoga Intervention BEHAVIORAL

Three yoga classes per week for 8 weeks.

Also known as: Yoga, Ashtanga

Yoga

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Lions Vision and Research Rehabilitation

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Parasomnias; Anxiety Disorders; Depression

Interventions

Yoga

Condition Hierarchy (Ancestors)

Eye Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ava Bittner, OD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: October 5, 2011
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

US (1)