Ocular HypertensionNCT04695314
Foot Reflexology in Ocular Hypertensive and Glaucoma Patients
A study testing Massage and Experimental insert in people with Ocular Hypertension and Glaucoma, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Hypertension, Glaucoma
- What is being tested?
- Massage and Experimental insert
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 18 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital Ophthalmology Clinic
Philadelphia, Pennsylvania, 19140
About this study
Official title: Effect of Foot Reflexology on Intraocular Pressure in Ocular Hypertensive and Glaucoma Patients
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.
Read the 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.
- Conditions
- Ocular Hypertension, Glaucoma
- Being tested
- Massage, Experimental insert, Sham insert
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageDevice
Also called JAPAN TSUBO HH-700
Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes
Experimental insertProcedure or surgery
Raised shoe insert, insert used for massage
Sham insertProcedure or surgery
Flat shoe insert, insert used for massage
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Group | Experimental | 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. Receives: Device: Massage |
| Ocular Hypertension Group A | Experimental | 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. Receives: Procedure: Experimental insert; Procedure: Sham insert |
| Ocular Hypertension Group B | Active comparator | 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. Receives: Procedure: Experimental insert; Procedure: Sham insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure Changes in Glaucoma Patients
Glaucoma Patients
Measured: 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
Measured: 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
Measured: Baseline and after experimental foot insert intervention, over an average of 8 hours
Intraocular Pressure Changes in Ocular Hypertensive Patients
Ocular Hypertensive Patients
Measured: Baseline and after sham foot insert intervention, over an average of 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start7 Nov 2017
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695314
- Sponsor's protocol ID
- 24685
- Status last verified
- Feb 2021
- First submitted
- 23 Dec 2020
- Last updated
- 5 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Reflexology on Intraocular Pressure in Ocular Hypertensive and Glaucoma Patients
- ClinicalTrials.gov ID
- NCT04695314
- Acronym / sponsor ID
- 24685
- Conditions
- Ocular Hypertension, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Group | Experimental | Device: MassagePatients 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. |
| Ocular Hypertension Group A | Experimental | Procedure: Experimental insert, Procedure: Sham insertPatients 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. |
| Ocular Hypertension Group B | Active comparator | Procedure: Experimental insert, Procedure: Sham insertPatients 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageAlso: JAPAN TSUBO HH-700Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes | Device | Glaucoma Group |
| Experimental insertRaised shoe insert, insert used for massage | Procedure or surgery | Ocular Hypertension Group A, Ocular Hypertension Group B |
| Sham insertFlat shoe insert, insert used for massage | Procedure or surgery | Ocular Hypertension Group A, Ocular Hypertension Group B |
Primary outcome
Intraocular Pressure Changes in Glaucoma Patients
Time frame: 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
Time frame: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours
Ocular Hypertensive Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients
Time frame: Baseline and after experimental foot insert intervention, over an average of 8 hours
Ocular Hypertensive Patients
Intraocular Pressure Changes in Ocular Hypertensive Patients
Time frame: Baseline and after sham foot insert intervention, over an average of 8 hours
Ocular Hypertensive Patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Ocular Hypertension
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and Experimental insert in people with Ocular Hypertension and Glaucoma, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure Changes in Glaucoma Patients (time frame: Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.