Effect of Acupuncture on Intraocular Pressure

NCT ID: NCT00639977

Last Updated: 2008-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Intraocular Pressure Acupuncture Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

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

20-minute session of acupuncture with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming)

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming

3

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers

Exclusion Criteria

* glaucoma
* past intraocular surgery
* corneal alterations
* medications that interferes with the intraocular pressure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal de São Paulo

Principal Investigators

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Daniel Meira-Freitas, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo

Angelino J Cariello, MD

Role: STUDY_CHAIR

Universidade Federal de São Paulo

Luiz Alberto S Melo Jr., MD

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo

Locations

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Departamento de Oftalmologia - UNIFESP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 20351373 (View on PubMed)

Other Identifiers

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CEP 1196/07

Identifier Type: -

Identifier Source: org_study_id