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Regulation of Intraocular Pressure in Glaucoma Patients by Acupressure

Primary Purpose

Primary Open Angle Glaucoma, Acupressure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupressure
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary Open Angle Glaucoma, High intraocular pressure, Acupressure, Bladder Meridian, Triple Burner Meridian

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Normal (Visual Field Defects: >-2.00 dB)

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

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

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

    Profound (Visual Field Defects: <-20 dB)

    Arm Description

    Do the formal acupressure

    Do the formal acupressure

    Do the formal acupressure

    Do the formal acupressure

    Do the formal acupressure

    Outcomes

    Primary Outcome Measures

    Intraocular pressure changes
    Tracking the intraocular pressure changes in patients with different stages of glaucoma after undergoing acupoint massage

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    June 2, 2023
    Last Updated
    June 9, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05898997
    Brief Title
    Regulation of Intraocular Pressure in Glaucoma Patients by Acupressure
    Official Title
    Regulation of Intraocular Pressure in Glaucoma Patients by Acupressure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    June 15, 2024 (Anticipated)
    Study Completion Date
    June 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Open Angle Glaucoma, Acupressure
    Keywords
    Primary Open Angle Glaucoma, High intraocular pressure, Acupressure, Bladder Meridian, Triple Burner Meridian

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Masking Description
    Open label
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal (Visual Field Defects: >-2.00 dB)
    Arm Type
    Experimental
    Arm Description
    Do the formal acupressure
    Arm Title
    Mild (Visual Field Defects: -2.00~-6.00 dB)
    Arm Type
    Experimental
    Arm Description
    Do the formal acupressure
    Arm Title
    Moderate (Visual Field Defects: -6.01~-12.00 dB)
    Arm Type
    Experimental
    Arm Description
    Do the formal acupressure
    Arm Title
    Severe (Visual Field Defects: -12.01~-20.00dB)
    Arm Type
    Experimental
    Arm Description
    Do the formal acupressure
    Arm Title
    Profound (Visual Field Defects: <-20 dB)
    Arm Type
    Experimental
    Arm Description
    Do the formal acupressure
    Intervention Type
    Behavioral
    Intervention Name(s)
    Acupressure
    Other Intervention Name(s)
    Acupuncture point massage
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Intraocular pressure changes
    Description
    Tracking the intraocular pressure changes in patients with different stages of glaucoma after undergoing acupoint massage
    Time Frame
    Monitored regularly at 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months.
    Secondary Outcome Measure Information:
    Title
    Visual field testing by optical coherence tomography (OCT)
    Description
    Tracking the changes of visual field testing by optical coherence tomography (OCT) in patients with different stages of glaucoma after undergoing acupoint massage
    Time Frame
    Monitored at 6 months and 12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ko Mei Lan, doctor
    Phone
    0972654211
    Email
    G51011@hch.gov.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Undecided

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    Regulation of Intraocular Pressure in Glaucoma Patients by Acupressure

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