Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorChina Medical University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Primary open angle glaucoma diagnosed at least 3 months ago.
Diagnosed with mild or moderate open angel glaucoma.
Use 1 or 2 kinds of glaucoma drugs.
Age ≥ 20 years old.
Disqualifiers
Accept any ophthalmic laser or surgery within one year.
High myopia.
Use of any drugs that affect intraocular pressure.
Visual acuity with correction lower than 0.2.
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Other interventionThe treatment will take place once a week, over six weeks. The needles will placed in the body for 20 minutes. A total of 12 Needles(6 acupoints, bilaterally) will be used in each session.Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation.
Acupuncture placebo
Other interventionA total of 12 Needles(6 acupoints, bilaterally) will be used in each session. Acupuncture points are different from the experimental group.The control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Ophthalmic Acupoint Treatment GroupExperimental treatment 1 intervention
Group B: Non-ophthalmological Acupoint Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intraocular pressure-pre-treatment
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Time frame
Every weeks pre-acupuncture treatment up to six weeks.2
Intraocular pressure-after-treatment
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Time frame
Every weeks 15 minutes after acupuncture treatment up to six weeks.3
Intraocular pressure-Change
Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg.
Time frame
Change from baseline intraocular pressure at 12 weeks.Secondary outcomes
1
Optical coherence tomography-RNFL symmety
The optic disk and the RNFL are the principal sites of apparent glaucomatous damage which precedes glaucomatous visual field alterations. RNFL symmety and Retinal nerve fiber layer (RNFL) thickness measurements obtained with Optical coherence tomography employs low-coherence interferometry.The unit of value is %.
Time frame
Change from baseline RNFL symmety at 12 weeks.2
Optical coherence tomography-C/D ratio
The optic disk and the RNFL are the principal sites of apparent glaucomatous damage which precedes glaucomatous visual field alterations. The cup/disc (C/D) ratio as a standardised method to evaluate the optic nerve obtained with Optical coherence tomography employs low-coherence interferometry.
Time frame
Change from baseline C/D ratio at 12 weeks.3
Optical coherence tomography angiography-RPC density
Optical coherence tomography angiography is a relatively new, non-invasive, dye-free imaging modality that provides a qualitative and quantitative assessment of the vasculature in the retina and optic nerve head. We use OCTA to complement visual field and OCT examinations to diagnose glaucoma, detect progression and evaluate the treatment of acupuncture. Using OCT angiograms, the RPC density was evaluated quantitatively. The unit of value is %.
Time frame
Change from baseline RPC density at 6 weeks.4
Central corneal thickness
To measure mean values of central corneal thickness (CCT) obtained by specular microscopy.
Time frame
On the first and 12th week for baseline and follow up tracing.Sponsors and contacts
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Source ClinicalTrials.gov