Clinical trial NCT04695314: Foot Reflexology in Ocular Hypertensive and Glaucoma Patients
Official title: Effect of Foot Reflexology on Intraocular Pressure in Ocular Hypertensive and Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Hypertension
Glaucoma
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 27
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Intraocular Pressure Changes in Glaucoma Patients
timeFrame: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours
measure: Intraocular Pressure Changes in Ocular Hypertensive Patients
timeFrame: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours
measure: Intraocular Pressure Changes in Ocular Hypertensive Patients
timeFrame: Baseline and after experimental foot insert intervention, over an average of 8 hours
measure: Intraocular Pressure Changes in Ocular Hypertensive Patients
timeFrame: Baseline and after sham foot insert intervention, over an average of 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital Ophthalmology Clinic
state: Pennsylvania
Study officials:
References: