Effect of Acupuncture on Intraocular Pressure

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00639977
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 3
• Duration (Months): 6
• Patients Per Site Per Month: 8.4

Study Details

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
• 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: Sep 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

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 [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• glaucoma

• past intraocular surgery

• corneal alterations

• medications that interferes with the intraocular pressure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00639977
• Other Study ID Numbers: CEP 1196/07
• First Posted: Mar 20, 2008
• Last Update Posted: Mar 20, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: Intraocular Pressure; Acupuncture; Healthy Volunteers

Study Results

No Results Posted as of Mar 20, 2008