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Effect of Acupuncture on Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00639977
First received: March 14, 2008
Last updated: March 19, 2008
Last verified: March 2008
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture on Intraocular Pressure

Resource links provided by NLM:

U.S. FDA Resources

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
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

  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
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

No publications provided by Federal University of São Paulo

Additional 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
Study First Received: March 14, 2008
Last Updated: March 19, 2008
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

ClinicalTrials.gov processed this record on May 16, 2013