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Die klinische Studie NCT05753137 für Glaukom, Akupunktur, Intraokulardruck ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial 50 Randomisiert
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Die klinische Studie NCT05753137 ist eine interventionsstudie zur Untersuchung von Glaukom, Akupunktur, Intraokulardruck und hat den Status offene rekrutierung. Die Studie startete am 28. Juni 2023 und soll 50 Teilnehmer aufnehmen. Durchgeführt von Medizinische Universität China, Taiwan ist der Abschluss für 27. Juni 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 3. Juli 2024 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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-ophthalmolog...Mehr anzeigen
Offizieller Titel
Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial
Erkrankungen
GlaukomAkupunkturIntraokulardruckPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- CMUH111-REC3-210
NCT-Nummer
Studienbeginn (tatsächlich)
2023-06-28
Zuletzt aktualisiert
2024-07-03
Studienende (vorauss.)
2025-06-27
Geplante Rekrutierung
50
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
Glaucoma
Acupuncture
Acupuncture
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellOphthalmic Acupoint Treatment Group Ophthalmic acupoint treatment group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time.
Acupuncture points: Fengchi(GB20), Cuanzhu(BL2), Sibai(ST2), Taiyang(EX-HN5), Hegu(LI4), Taichong(LR3), a total of six acupoints. | Akupunktur The 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. |
Placebo-VergleichspräparatNon-ophthalmological Acupoint Control Group Non-ophthalmological acupoint control group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time.
Acupuncture points: Yinlingquan(SP9), Liangqiu (ST34),Xiajuxu(ST39), Yanglingquan (GB34), Shousanli(LI10), Sanyangluo(TE8), a total of six acupoints. The Non-ophthalmological acupoint control group points are not indicated for the treatment of ophthalmological related p...Mehr anzeigen | Acupuncture placebo A 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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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. | Every weeks pre-acupuncture treatment up to six weeks. |
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. | Every weeks 15 minutes after acupuncture treatment up to six weeks. |
Intraocular pressure-Change | Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg. | Change from baseline intraocular pressure at 12 weeks. |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 %. | Change from baseline RNFL symmety at 12 weeks. |
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. | Change from baseline C/D ratio at 12 weeks. |
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 %. | Change from baseline RPC density at 6 weeks. |
Central corneal thickness | To measure mean values of central corneal thickness (CCT) obtained by specular microscopy. | On the first and 12th week for baseline and follow up tracing. |
Glaucoma Symptom Scale | The Glaucoma Symptom Scale (GSS) is a simple and brief glaucoma-specific questionnaire aimed at quantifying complaints and functional impairment in patients with glaucoma. We used 1998 version of the Glaucoma Symptom Scale (GSS; Lee et al., 1998) Questionnaire.The items include 10 ocular complaints, for each eye, a 5-level score is generated, ranging from 0 (complaint present and very bothersome) to 4 (complaint absent). This score is then transformed to a 0 to 100 scale, with 0 representing presence of a very bothersome problem and 100 representing absence of a problem. | On the first and 12th week for baseline and follow up tracing. |
Glaucoma Quality of Life - 15 | The GQL-15 questionnaire is composed of 15 items. A 5-point rating scale for the level of difficulty of each task totals a score from 0 to 75. A higher score signifies a poorer . | On the first and 12th week for baseline and follow up tracing. |
Blood pressure | We measure the blood pressure of patient before and after acupuncture treatment .Both systolic and diastolic blood pressure will be measured. | we measure blood pressure every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing. |
Heart rate | We measure the heart rate of patient before and after acupuncture treatment . | we measure heart rate every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing. |
Best corrected visual acuity | Best possible vision a an eye can see with corrective lenses, measured in terms of Snellen lines. | Change from baseline best corrected visual acuity at 12 weeks. |
Visual field- mean deviation | The visual field refers to the total area in which objects can be seen in the side (peripheral) vision as you focus your eyes on a central point. Visual field will measured with automated perimetry.The unit of value is dB. | Change from baseline visual field at 12 weeks. |
Visual field- visual field index | The visual field refers to the total area in which objects can be seen in the side (peripheral) vision as you focus your eyes on a central point. Visual field will measured with automated perimetry. Visual field index intuitive presentation may underestimate the visual loss. | Change from baseline visual field at 12 weeks. |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
20 Years
Zugelassene Geschlechter
Alle
- 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.
- Participants sign the informed consent and cooperate with the experimental procedures.
- 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.
- Previous or existing uveitis or retinopathy.
- Unable to receive acupuncture treatment continuously or allergic to acupuncture needles.
- Pregnancy or breastfeeding.
- Refusal to sign the informed consent form.
Zentrale Studienkontakte
Kontakt: LEE YU-CHEN, Ph.D, 886-4-22052121, [email protected]
1 Studienstandorte in 1 Ländern
China Medical University Hospital, Taichung, Taiwan
Lee Yu-Chen, Ph.D, Kontakt, +886-975-682-023, [email protected]
Offene Rekrutierung