Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension

NCT02993445 | Completed Results

• 1 other identifier: 22105
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effect of complementary and alternative therapies, specifically alternate nostril breathing and foot reflexology, on intraocular pressure in patients with ocular hypertension.

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Intraocular Pressure (mmHg)

  Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins.

  2 hours

• Change From Baseline in Intraocular Pressure (mmHg)

  Measurement of intraocular pressure after each treatment for 30min intervals for total of 2hours. Time points used in the calculation include baseline, 30 mins, 60 mins, 90 mins, and 120 mins. This is after the 2 week washout period. Participants have switched interventions

  2 hours

Study Arms (2)

Alternate Nostril Breathing

EXPERIMENTAL

The procedure for ANB begins by bringing the right hand up to the nose; with the ring finger over the left nostril and the thumb over the right nostril, so that the nostrils may be closed by the fingers. The first step in the cycle is to hold the right nostril closed with the thumb, and exhale completely through the left nostril in a slow and controlled fashion, free from exertion and jerkiness. At the end of the exhalation, the patient will inhale slowly and completely back through the left nostril. At this point the patient will close the left nostril with the ring finger, open the right nostril by releasing the thumb, and repeat the exhale-inhale process through the right nostril, completing one cycle. Then the patient will switch back to the left nostril and begin the cycle again. This cycle will be performed for one session lasting approximately 5 minutes.

Other: Alternate Nostril Breathing

Foot Reflexology

EXPERIMENTAL

The procedure for FR focuses on activating specific reflex areas on the foot linked with the eye and eye disease, via massage. Although in the interest of repeatable precision, we have decided to use a FR board (fig.1) to conduct the procedure. This board has two foot shaped pieces of wood mounted on a flat board with springs. On top of these wooden feet are small wooden nodes, which are organized at precise locations to activate the reflexology of the foot by stimulation certain pressure points. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.

Device: Foot Reflexology

Interventions

Alternate Nostril Breathing OTHER

Alternate Nostril Breathing

Foot Reflexology DEVICE

Foot Reflexology

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with ocular hypertension

You may not qualify if:

• currently performed alternate nostril breathing or foot reflexology
• were unable to perform the task
• had previous eye surgery or laser,
• were receiving other CAM for ocular hypertension
• were unable to complete a washout period if they using glaucoma eye drops

Sponsors & Collaborators

• Temple University: lead

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

Small sample size; No control group

Results Point of Contact

• Title: Dr. Jeffrey Henderer
• Organization: Temple University Hospital

Jeffrey.Henderer@tuhs.temple.edu

267-418-9126

Study Officials

• Jeffrey Henderer, M.D.

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 15, 2016
• Study Start: September 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 27, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share