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NCT00639977 Clinical Trial

Effect of Acupuncture on Intraocular Pressure

Healthy Clinical Trial

Official title:
Effect of Acupuncture on Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00639977
Other study ID # CEP 1196/07
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 14, 2008
Last updated March 19, 2008
Start date September 2007
Est. completion date March 2008

Study information
Verified date March 2008
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in ResearchBrazil: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

- glaucoma

- past intraocular surgery

- corneal alterations

- medications that interferes with the intraocular pressure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Acupuncture
20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming
• Sham
20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians

Locations
Country Name City State
Brazil Departamento de Oftalmologia - UNIFESP São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary variation of the intraocular pressure 24 hours No
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