Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
To determine the effect of foot reflexology in primary open angle glaucoma (POAG) patients and the effect of a shoe insert to perform continuous foot reflexology in ocular hypertensive (OHTN) patients.

Detailed Description
-----------------
This is a prospective pilot study in glaucoma patients and a prospective therapeutic trial in ocular hypertensive patients. Patients were recruited from the Temple Ophthalmology outpatient clinic. Primary open-angle glaucoma patients were recruited from those about to have SLT for additional intraocular pressure (IOP) lowering. OHTN patients were recruited from the clinic. The glaucoma patients performed a 5-minute foot massage on a foot massage board and the IOP was checked pre-massage, post-massage and 30, 60, 90 and 120 min post massage. OHTN patients underwent a one-month drop washout and then performed a 5-minute massage using a 3D-printed shoe insert with the identical pressure checks. They then were randomly assigned to wear the shoe insert or a sham insert for one day. IOP was checked before inserting the insert and at the end of the day. The number of steps was recorded each day.

Official Title
-----------------
Effect of Foot Reflexology on Intraocular Pressure in Ocular Hypertensive and Glaucoma Patients

Conditions
-----------------
Ocular Hypertension, Glaucoma

Intervention / Treatment
-----------------
* Device: Massage
* Procedure: Experimental insert
* Procedure: Sham insert


Participation Criteria
=================
Eligibility Criteria
-----------------
The inclusion criteria for this study in each study group are as follows. Patients with ocular hypertension (age 30-90) who may or may not have been included in the original pilot study. Patients with POAG (age 30-90) who are being asked to increase therapy to further lower their IOP. The exclusion criteria for BOTH study groups will be: Current participation in FR or other complementary and alternative medicine techniques who will not participate in a washout period. Ocular hypotensive drop treatments for ocular-hypertension who will not participate in a washout period. Previous eye surgery or laser treatment. Physical inability to perform the tasks. Additional exclusion criteria for the Foot Insert ONLY will be: Diabetes Parkinson's Disease Neuropathy Gait Abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glaucoma Group<br>Patients with glaucoma come in and get an intraocular pressure check at baseline. They get a 5 minute foot massage and then have their intraocular pressure checked every 30 minutes over 2 hour span. | Device: Massage<br>* Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes<br>* Other names: JAPAN TSUBO HH-700;|
| Experimental: Ocular Hypertension Group A<br>Patients with OHTN come in and get an IOP check at baseline. They get a 5 minute foot massage and then have their IOP checked every 30 minutes over 2 hour span. 2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received raised experimental shoe insert. Patients come back in the afternoon to have their IOP checked again. 2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received sham flat shoe insert. Patients come back in the afternoon to have their IOP checked again. | Procedure: Experimental insert<br>* Raised shoe insert, insert used for massage<br>Procedure: Sham insert<br>* Flat shoe insert, insert used for massage<br>|
| Active Comparator: Ocular Hypertension Group B<br>Patients with OHTN come in and get an IOP check at baseline. They get a 5 minute foot massage and then have their IOP checked every 30 minutes over 2 hour span. 2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received sham flat shoe insert. Patients come back in the afternoon to have their IOP checked again. 2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received raised experimental shoe insert. Patients come back in the afternoon to have their IOP checked again. | Procedure: Experimental insert<br>* Raised shoe insert, insert used for massage<br>Procedure: Sham insert<br>* Flat shoe insert, insert used for massage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure Changes in Glaucoma Patients | Glaucoma Patients | Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours | 
| Intraocular Pressure Changes in Ocular Hypertensive Patients | Ocular Hypertensive Patients | Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours | 
| Intraocular Pressure Changes in Ocular Hypertensive Patients | Ocular Hypertensive Patients | Baseline and after experimental foot insert intervention, over an average of 8 hours | 
| Intraocular Pressure Changes in Ocular Hypertensive Patients | Ocular Hypertensive Patients | Baseline and after sham foot insert intervention, over an average of 8 hours |