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Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension

NCT ID: NCT02993445

Last Updated: 2020-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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11 patients were recruited from Temple Ophthalmology between 2014 and 2016. Patients had ocular hypertension and were between the ages of 48-74. Patients were excluded if they currently performed ANB or FR, were unable to perform the task, had previous eye surgery or laser, were receiving other CAM for ocular hypertension, or were unable to complete a washout period. After a 30-day drug washout, patients completed either ANB or FR. After instruction, the assigned task was performed for 5 minutes. FR was done on a commercially available foot reflexology board (JAPAN TSUBO HH-700) focused at the base of the second and third toes of both feet. Two weeks later, patients completed the alternate task. IOP was measured before the task, immediately after the task and then every 30 minutes for two hours. Sign rank tests were used to evaluate IOP changes within and between each group.

Conditions

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Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alternate Nostril Breathing

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.

Group Type EXPERIMENTAL

Alternate Nostril Breathing

Intervention Type OTHER

Foot Reflexology

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.

Group Type EXPERIMENTAL

Foot Reflexology

Intervention Type DEVICE

Interventions

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Alternate Nostril Breathing

Intervention Type OTHER

Foot Reflexology

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with ocular hypertension

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Henderer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Temple University

Other Identifiers

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22105

Identifier Type: -

Identifier Source: org_study_id