Trial Outcomes & Findings for Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension (NCT NCT02993445)
NCT ID: NCT02993445
Last Updated: 2020-11-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
2 hours
Results posted on
2020-11-27
Participant Flow
After a 30-day drug washout, patients were randomly assigned to complete either ANB or FR for 5 min. After instruction, patients completed either ANB or FR, and completed the alternate task 2 weeks later.
Unit of analysis: eyes
Participant milestones
| Measure |
Alternate Nostril Breathing First, Then Foot Reflexology
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.
Patients will complete 2 week wash out and then return for 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. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
|
Foot Reflexology First, Then Alternate Nostril Breathing
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. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
Patients will complete 2 week wash out and then return for 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.
|
|---|---|---|
|
First Intervention (5 Minutes)
STARTED
|
6 12
|
5 10
|
|
First Intervention (5 Minutes)
COMPLETED
|
6 12
|
5 10
|
|
First Intervention (5 Minutes)
NOT COMPLETED
|
0 0
|
0 0
|
|
Washout (2 Weeks)
STARTED
|
6 12
|
5 10
|
|
Washout (2 Weeks)
COMPLETED
|
6 12
|
5 10
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0 0
|
0 0
|
|
Second Intervention (5 Mins)
STARTED
|
6 12
|
5 10
|
|
Second Intervention (5 Mins)
COMPLETED
|
6 12
|
5 10
|
|
Second Intervention (5 Mins)
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Alternate Nostril Breathing First, Then Foot Reflexology
n=6 Participants
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.
Patients will complete 2 week wash out and then return for 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. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
|
Foot Reflexology First, Then Alternate Nostril Breathing
n=5 Participants
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. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
Patients will complete 2 week wash out and then return for 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.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 9.69 • n=99 Participants
|
65.4 years
STANDARD_DEVIATION 7.44 • n=107 Participants
|
62.64 years
STANDARD_DEVIATION 8.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Corneal Thickness
Right Eye
|
567.8 mm
STANDARD_DEVIATION 36.78 • n=99 Participants
|
572.7 mm
STANDARD_DEVIATION 37.0 • n=107 Participants
|
569.6 mm
STANDARD_DEVIATION 34.21 • n=206 Participants
|
|
Corneal Thickness
Left Eye
|
568.2 mm
STANDARD_DEVIATION 39.7 • n=99 Participants
|
575.3 mm
STANDARD_DEVIATION 53.1 • n=107 Participants
|
570.88 mm
STANDARD_DEVIATION 41.49 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 hoursMeasurement 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.
Outcome measures
| Measure |
Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology
n=6 Participants
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.
Patients will complete 2 week wash out and then return for 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. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
|
Foot Reflexology First, Then Alternate Nostril Breathing
n=10 eyes
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. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
Patients will complete 2 week wash out and then return for 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.
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure (mmHg)
Baseline
|
25.3 mm Hg
Standard Deviation 1.61
|
26.8 mm Hg
Standard Deviation 4.39
|
|
Change From Baseline in Intraocular Pressure (mmHg)
30 minutes IOP
|
23.9 mm Hg
Standard Deviation 2.19
|
22.5 mm Hg
Standard Deviation 4.12
|
|
Change From Baseline in Intraocular Pressure (mmHg)
60 minutes IOP
|
23.5 mm Hg
Standard Deviation 2.35
|
22.7 mm Hg
Standard Deviation 4.03
|
|
Change From Baseline in Intraocular Pressure (mmHg)
90 minutes IOP
|
21 mm Hg
Standard Deviation 2.66
|
22.5 mm Hg
Standard Deviation 3.64
|
|
Change From Baseline in Intraocular Pressure (mmHg)
120 minutes IOP
|
22.6 mm Hg
Standard Deviation 2.9
|
25.3 mm Hg
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: 2 hoursMeasurement 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
Outcome measures
| Measure |
Alternate Nostril Breathing Alternate Nostril Breathing First, Then Foot Reflexology
n=12 eyes
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.
Patients will complete 2 week wash out and then return for 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. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
|
Foot Reflexology First, Then Alternate Nostril Breathing
n=10 eyes
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. The patient will be instructed to rest their feet on these boards with a comfortable pressure for a period of 5 minutes.
Patients will complete 2 week wash out and then return for 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.
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure (mmHg)
Baseline
|
24.3 mm Hg
Standard Deviation 2.22
|
26.5 mm Hg
Standard Deviation 4.43
|
|
Change From Baseline in Intraocular Pressure (mmHg)
30 minutes IOP
|
21.3 mm Hg
Standard Deviation 2.00
|
23.9 mm Hg
Standard Deviation 3.99
|
|
Change From Baseline in Intraocular Pressure (mmHg)
60 minutes IOP
|
20.6 mm Hg
Standard Deviation 2.00
|
23.45 mm Hg
Standard Deviation 4.02
|
|
Change From Baseline in Intraocular Pressure (mmHg)
90 minutes IOP
|
20.4 mm Hg
Standard Deviation 2.08
|
22.7 mm Hg
Standard Deviation 4.33
|
|
Change From Baseline in Intraocular Pressure (mmHg)
120 minutes IOP
|
20.6 mm Hg
Standard Deviation 2.23
|
22.7 mm Hg
Standard Deviation 3.65
|
Adverse Events
Alternate Nostril Breathing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Foot Reflexology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place