Effect of Acupuncture on Intraocular Pressure
1 other identifier
interventional
50
1 country
1
Brief Summary
To evaluate the short-term effect of acupuncture on the intraocular pressure (IOP). Methods: A randomized controlled trial. Healthy volunteers will be randomly allocated to three groups: Acupuncture group - will be submitted to a 20-minute session of acupuncture with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming); Sham group - will be submitted to a 20- minute session of acupuncture with needles inserted in false points located 1 cm from true points in areas without acupuncture's meridians; and Control group - no intervention. IOP measurement by a masked investigator using Goldmann applanation tonometry immediately before the intervention, as well as 30 minutes and 24 hours after the acupuncture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Sep 2007
Typical duration for phase_1 healthy
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
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 14, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedMarch 20, 2008
March 1, 2008
6 months
March 14, 2008
March 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
variation of the intraocular pressure
24 hours
Study Arms (3)
2
SHAM COMPARATOR20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians
1
ACTIVE COMPARATOR20-minute session of acupuncture with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming)
3
NO INTERVENTIONInterventions
20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming
20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians
Eligibility Criteria
You may qualify if:
- healthy volunteers
You may not qualify if:
- glaucoma
- past intraocular surgery
- corneal alterations
- medications that interferes with the intraocular pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departamento de Oftalmologia - UNIFESP
São Paulo, São Paulo, Brazil
Related Publications (1)
Meira-Freitas D, Cariello AJ, Vita RC, Tabosa A, Melo LA Jr. Short-term effect of acupuncture on intraocular pressure in healthy subjects. Acupunct Med. 2010 Mar;28(1):25-7. doi: 10.1136/aim.2009.001081.
PMID: 20351373DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Meira-Freitas, MD
Universidade Federal de São Paulo
- STUDY CHAIR
Angelino J Cariello, MD
Universidade Federal de São Paulo
- STUDY DIRECTOR
Luiz Alberto S Melo Jr., MD
Universidade Federal de São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 14, 2008
First Posted
March 20, 2008
Study Start
September 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
March 20, 2008
Record last verified: 2008-03