Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine the influence of specific eye acupuncture to the ocular microcirculation in diabetic and healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Oct 2009
Longer than P75 for phase_2 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 26, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedDecember 2, 2011
December 1, 2011
1 year
November 26, 2009
December 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
retinal perfusion by HRF/OBF/RVA
post acupuncture (one day measurement)
Study Arms (2)
diabetics
ACTIVE COMPARATORsubjects with HbA1c \>7,0 and pathological glucose tolerance testing
healthy
ACTIVE COMPARATORhealthy subjects with HbA1c \<7,0 and negative glucose tolerance testing
Interventions
acupuncture of the eye in traditional chinese schematics
Eligibility Criteria
You may qualify if:
- persons over 18 years, men or women, diabetic diagnostics within the last year
You may not qualify if:
- medical use of anticoagulative substances, use of dorzolamide, use of immunosuppressive medication
- psychiatrics, epileptics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Carl Gustav Carus
Dresden, Saxony, 01307, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janek - Haentzschel, Dr.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 26, 2009
First Posted
December 1, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
May 1, 2012
Last Updated
December 2, 2011
Record last verified: 2011-12