Effect of Acupuncture on Intraocular Pressure - Full Text View

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00639977

Purpose

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.

Condition	Intervention	Phase
Healthy	Other: Acupuncture Other: Sham	Phase I Phase II

MedlinePlus related topics: Acupuncture

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Acupuncture on Intraocular Pressure

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

variation of the intraocular pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	September 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Sham Comparator 20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians	Other: 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
1: Active Comparator 20-minute session of acupuncture with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming)	Other: Acupuncture 20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming
3: No Intervention

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

glaucoma
past intraocular surgery
corneal alterations
medications that interferes with the intraocular pressure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639977

Locations

Brazil, SP
Departamento de Oftalmologia - UNIFESP
São Paulo, SP, Brazil

Sponsors and Collaborators

Federal University of São Paulo

Investigators

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

More Information

Responsible Party:	Universidade Federal de São Paulo ( Daniel Meira Freitas )
Study ID Numbers:	CEP 1196/07
Study First Received:	March 14, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00639977
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health

Keywords provided by Federal University of São Paulo:

Intraocular Pressure
Acupuncture
Healthy Volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009