Regulation of Intraocular Pressure in Glaucoma Patients by Acupressure

NCT05898997 | Completed

• 1 other identifier: 202303119RINA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Primary Open Angle Glaucoma; Acupressure

Keywords

Primary Open Angle Glaucoma; High intraocular pressure; Acupressure; Bladder Meridian; Triple Burner Meridian

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual field testing by optical coherence tomography (OCT)

  Monitored at 6 months and 12 months.

Study Arms (5)

Normal (Visual Field Defects: >-2.00 dB)

EXPERIMENTAL

Do the formal acupressure

Behavioral: Acupressure

Mild (Visual Field Defects: -2.00~-6.00 dB)

EXPERIMENTAL

Do the formal acupressure

Behavioral: Acupressure

Moderate (Visual Field Defects: -6.01~-12.00 dB)

EXPERIMENTAL

Do the formal acupressure

Behavioral: Acupressure

Severe (Visual Field Defects: -12.01~-20.00dB)

EXPERIMENTAL

Do the formal acupressure

Behavioral: Acupressure

Profound (Visual Field Defects: <-20 dB)

EXPERIMENTAL

Do the formal acupressure

Behavioral: Acupressure

Interventions

Acupressure BEHAVIORAL

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.

Also known as: Acupuncture point massage

Mild (Visual Field Defects: -2.00~-6.00 dB); Moderate (Visual Field Defects: -6.01~-12.00 dB); Normal (Visual Field Defects: >-2.00 dB); Profound (Visual Field Defects: <-20 dB); Severe (Visual Field Defects: -12.01~-20.00dB)

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, Taiwan

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients included in the study were between the ages of 15 and 80 and were classified into 5 groups based on their visual field defect levels.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: June 15, 2023
• Primary Completion: April 16, 2024
• Study Completion: April 25, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)