Trial document





This trial has been registered retrospectively.
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  DRKS00013955

Trial Description

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Title

Effect of acupuncture on retinal microcirculation and function

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Trial Acronym

RVA and acupuncture

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URL of the Trial

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Brief Summary in Lay Language

Some patients experience deterioration of visual fields and/or vision related quality of life despite best conventional medical treatment with drugs and surgical methods. Modern treatment usually controls well the intraocular pressure but no treatment method to normalize the regulation of blood flow to the eye is known as yet. Patients threatened with visual loss often turn to non-conventional methods. While these methods cannot be considered an alternative, they may well play a useful complementary role. This study measures any potential change in blood flow variability of the retina and other functional visual parameters before and after acupuncture treatment.

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Brief Summary in Scientific Language

Background to this open prospective, non-randomized trial is the investigation of microcirculation (Retinal Vessel Analyzer), objective retinal function (mf ERG and flash ERG), as well as standard tests of visual function (visual acuity, contrast sensitivity, visual fields), of intraocular pressure and of the psychoemotional state of the patients (questionnaires). These tests will be done before and after 10 sessions of acupuncture according to a standardised protocol. Only if the patient is considered for acupuncture and after throrough information about the treatment will they be informed and recruited about the study.

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Organizational Data

  •   DRKS00013955
  •   2018/03/22
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  •   yes
  •   Approved
  •   EK 011/17, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

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Health Condition or Problem studied

  •   H40-H42 -  Glaucoma
  •   CHRONIC DEGENERATIVE EYE DISEASE
  •   H35 -  Other retinal disorders
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Interventions/Observational Groups

  •   Background of the non-randomized prospective open study is the investigation of the microcirculation with the retinal vessel analyzer, fo objective retinal function with electrophysiological means, of standard clinical tests of visual function and of the psychoemotional situation before and after 10 sessions of acupuncture. These are applied during 5 days over two weeks following a standardized protocol. Local points around the orbits within the first and second branch of the trigeminal supply (BL2, YuYao, TaiYang, ST2, Yin Tang, Du 20 & auricular points); cervical segmental points at the hand (LI4, Dahlgren Punkt, Punkte nach Boel), Distal points (ST36-LR3. SP6-SP9 & GB37, BL60, BL67) verwendet. Two periorbital points on each side are stimulated at threshold, two distal points on each side suprathreshold with electroacupuncture. Parameter der EA: 2 Hz, 210 µs 3 s ↔ 100Hz, 120 µs, 3s über 30 min.
    THere are two sessions daily in the prone position with one hour's break in between.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Spontaneous retinal vascular pulsation, focal structural dynamic changes of the retinal vessels and of vessel stiffness before and after intervention is determined statistically through the reactivity of the vessels. The end point is the variation in vessel diameter in response to flicker stimulation in the video recording expressed in "units of measurement".

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Secondary Outcome

Visual acuity (in percentage) reading a Snellen's chart, visual field (mean deviation) Humphriss perimeter and Frequency doubling technique, contrast sensitivity (percentage per frequency) reading the CSV-1000 chart, Intraocular pressure (mmHg) with Goldmann tonometer, central retinal potentials (amplitude in mV) with the multifocal pattern electroretinogramme, photopic negative response (quotient) with the flash electroretinogramme, questionnaires regarding psychoemtional state, quality of life (scaled questionnaires). All of those before and after treatment.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/05/06
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with glaucoma and other degenerative retinal or optic nerve disease if acupuncture is being considered.

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Exclusion Criteria

Patients who for mental, health or legal reasons are unable to understand the course of the study or unable to consent
Patients who are unable to focus on the monitor for mfERG or the leading light of the RVA
Patients who show eye pathology that would prevent a valid testing with mfERG or RVA
Patients who would need to drive the same day (mydriasis)
Patients who are pregnant, breastfeeding or cannot exclude a potential pregnancy

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Addresses

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    • Augenzentrum am Annapark
    • Ms.  Dr med  E  Rom 
    • Steigerweg 3
    • Alsdorf  52477
    • Germany
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    • Augenzentrum am Annapark
    • Ms.  Dr.med  E  Rom 
    • Steigerweg 3
    • 52477  Alsdorf
    • Germany
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    • Augenzentrum am Annapark
    • Ms.  Dr med  Edith  Rom 
    • Steigerweg 3
    • 52477  Alsdorf
    • Germany
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Sources of Monetary or Material Support

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    • Augenzentrum am Annapark
    • Steigerweg 3
    • 52077  Alsdorf
    • Germany
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    • Augenklinik Universitätsklinikum Aachen
    • Mr.  Prof.Dr.med.  N  Plange 
    • Pauwelsstr.30
    • 52057  Aachen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.