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Effect of Acupuncture on Intraocular Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00639977
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 20, 2008
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Healthy Other: Acupuncture Other: Sham Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture on Intraocular Pressure
Study Start Date : September 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Sham Comparator: 2
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
Active Comparator: 1
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
No Intervention: 3


Outcome Measures

Primary Outcome Measures :
  1. variation of the intraocular pressure [ Time Frame: 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639977


Locations
Brazil
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Meira Freitas, Universidade Federal de São Paulo
ClinicalTrials.gov Identifier: NCT00639977     History of Changes
Other Study ID Numbers: CEP 1196/07
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: March 20, 2008
Last Verified: March 2008

Keywords provided by Federal University of São Paulo:
Intraocular Pressure
Acupuncture
Healthy Volunteers