Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial

Last updated: June 30, 2024
Sponsor: China Medical University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Acupuncture

Acupuncture placebo

Clinical Study ID

NCT05753137
CMUH111-REC3-210
  • Ages > 20
  • All Genders

Study Summary

This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. A randomized, controlled trial involving 50 subjects will be conducted and observed for 12 weeks to evaluate the clinical efficacy of acupuncture. This study aims to provide a reference for future clinical treatment guidelines.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Primary open angle glaucoma diagnosed at least 3 months ago.

  2. Diagnosed with mild or moderate open angel glaucoma.

  3. Use 1 or 2 kinds of glaucoma drugs.

  4. Age ≥ 20 years old.

  5. Participants sign the informed consent and cooperate with the experimentalprocedures.

Exclusion

Exclusion Criteria:

  1. Accept any ophthalmic laser or surgery within one year.

  2. High myopia.

  3. Use of any drugs that affect intraocular pressure.

  4. Visual acuity with correction lower than 0.2.

  5. Previous or existing uveitis or retinopathy.

  6. Unable to receive acupuncture treatment continuously or allergic to acupunctureneedles.

  7. Pregnancy or breastfeeding.

  8. Refusal to sign the informed consent form.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Acupuncture
Phase:
Study Start date:
June 28, 2023
Estimated Completion Date:
June 27, 2025

Study Description

This clinical trial utilized acupuncture as an adjunctive treatment for glaucoma patients. It is estimated a randomized clinical trial that 50 subjects will be enrolled and observed for 12 weeks to evaluate the clinical efficacy of acupuncture, providing a reference for future clinical treatment guidelines. Participants will be randomly divided into two groups: Ophthalmic Acupoint Treatment Group and Non-ophthalmological Acupoint Control Group. Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation. Conversely, the control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation. Both groups will undergo acupuncture therapy once a week for a total of six sessions and will be observed for twelve weeks. On each visit, intraocular pressure, blood pressure, and heart rate will be assessed. Questionnaires of Glaucoma Symptom Scale (GSS) and The Glaucoma Quality of Life-15 (GQL-15) will be performed. The data of central corneal thickness, optical coherence tomography angiography, optical coherence tomography, visual field, and best-corrected visual acuity will be collected and analyzed before acupuncture and in the 12th week.

Connect with a study center

  • China Medical University Hospital

    Taichung,
    Taiwan

    Active - Recruiting

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