Regulation of Intraocular Pressure in Glaucoma Patients by Acupressure

The purpose of this clinical trial is to implement acupressure twice daily and monitor the changes in intraocular pressure (IOP) in patients with different levels of glaucoma. The study aims to investigate the effects of this method on IOP, visual field, retinal nerve fiber layer thickness measured by optical coherence tomography, blood vessel density, and macular ganglion cell layer thickness and density in patients with primary open-angle glaucoma (POAG).

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Acupressure
• Intervention / Treatment: Behavioral: Acupressure

Detailed Description

[Background] With the advancement of medical technology, many diseases can be controlled through Western medicine. However, there are still some diseases that cannot be effectively treated with Western medicine alone. Therefore, this article approaches the treatment of glaucoma from the perspective of traditional Chinese medicine meridians, by using acupressure to verify its effectiveness in reducing intraocular pressure in glaucoma patients.

[Participants] Between May 2023 and February 2024, a total of 80 patients were randomly selected from the ophthalmology outpatient clinic of National Taiwan University Hospital Hsinchu Branch. The patients included in the study were between the ages of 15 and 80 and were classified into 5 groups based on their intraocular pressure (IOP) levels.

The inclusion criteria were primary open-angle glaucoma and high IOP. Patients with angle-closure glaucoma, and those who had previously undergone eye surgery were excluded from the study.

[Materials and Methods] Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.

[Postoperative follow-up and evaluation] After one week, the best corrected visual acuity and changes in intraocular pressure will be followed up, and changes in intraocular pressure will be monitored regularly at 1 month, 3 months, 6 months, 9 months, and 12 months. Visual field testing and optical coherence tomography (OCT) will be monitored regularly at 6 months and 12 months.

[Data Statistics and Analysis] Record the subjects' intraocular pressure and visual acuity for statistical analysis. IBM SPSS v21.0 statistical software (IBM Corporation, New York, USA) will be used to calculate descriptive statistics, including mean ± standard deviation (±SD), median, range, and frequency and percentage as appropriate.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan
    • National Taiwan University Hospital, Hsin-Chu Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with primary open-angle glaucoma, normal-tension glaucoma, and high intraocular pressure.

Exclusion Criteria:

• Patients with narrow-angle glaucoma, patients who have undergone eye surgery during the study period, patients who are unable to learn the acupoint massage procedure or unable to perform it regularly.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal (Visual Field Defects: >-2.00 dB); Do the formal acupressure	Behavioral: Acupressure; Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.; Other Names: Acupuncture point massage
Experimental: Mild (Visual Field Defects: -2.00~-6.00 dB); Do the formal acupressure	Behavioral: Acupressure; Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.; Other Names: Acupuncture point massage
Experimental: Moderate (Visual Field Defects: -6.01~-12.00 dB); Do the formal acupressure	Behavioral: Acupressure; Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.; Other Names: Acupuncture point massage
Experimental: Severe (Visual Field Defects: -12.01~-20.00dB); Do the formal acupressure	Behavioral: Acupressure; Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.; Other Names: Acupuncture point massage
Experimental: Profound (Visual Field Defects: <-20 dB); Do the formal acupressure	Behavioral: Acupressure; Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.; Other Names: Acupuncture point massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure changes	Tracking the intraocular pressure changes in patients with different stages of glaucoma after undergoing acupoint massage	Monitored regularly at 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual field testing by optical coherence tomography (OCT)	Tracking the changes of visual field testing by optical coherence tomography (OCT) in patients with different stages of glaucoma after undergoing acupoint massage	Monitored at 6 months and 12 months.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): April 16, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Acupressure; Primary Open Angle Glaucoma; High intraocular pressure; Bladder Meridian; Triple Burner Meridian
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 202303119RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No