Foot Reflexology in Ocular Hypertensive and Glaucoma Patients

Not Applicable

Completed

• Conditions: Ocular Hypertension; Glaucoma

• Registration Number: NCT04695314
• Lead Sponsor: Temple University

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.

Study Timeline

• Study Start: 2017-11-07
• Primary Completion: 2020-11-18
• Study Completion: 2020-11-18
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure Changes in Glaucoma Patients	Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours	Glaucoma Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients	Baseline and after sham foot insert intervention, over an average of 8 hours	Ocular Hypertensive Patients

Trial Locations

Locations (1)

Temple University Hospital Ophthalmology Clinic; 🇺🇸 Philadelphia, Pennsylvania, United States