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Completed

NCT Number: NCT02993445

Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alternate Nostril Breathing

Other

Foot Reflexology

Device

Primary outcomes

  1. Change From Baseline in Intraocular Pressure (mmHg)

    Time frame: 2 hours

    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. Change From Baseline in Intraocular Pressure (mmHg)

    Time frame: 2 hours

    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

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

A Pilot Study on the Effect of Alternate Nostril Breathing and Foot Reflexology on Intraocular Pressure in Ocular Hypertension

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 15, 2016
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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