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Acupuncture for Elevated Intraocular Pressure

Primary Purpose

Elevated Intraocular Pressure

Status
Terminated
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elevated Intraocular Pressure focused on measuring acupuncture, intraocular pressure, glaucoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients of either gender; age 21 years and older; intraocular pressure equal/greater than 20mmHg, equal/less than 30mmHg; ability to comply with study protocol Exclusion Criteria: patients with secondary or closed-angle glaucoma; patients with a history of laser or other surgical treatment of glaucoma; patients displaying symptoms of depression, anxiety or psychosis

Sites / Locations

  • Dept. of Ophthalmology, Shaare Zedek Medical Center

Outcomes

Primary Outcome Measures

Intraocular pressure curves.

Secondary Outcome Measures

safety of acupuncture treatment

Full Information

First Posted
March 27, 2006
Last Updated
September 30, 2007
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00307918
Brief Title
Acupuncture for Elevated Intraocular Pressure
Official Title
Acupuncture Treatment for Elevated Intraocular Pressure: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Why Stopped
lack of patients
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

5. Study Description

Brief Summary
Glaucoma is the leading cause of irreversible blindness in the world, resulting from progressive axonal destruction of the optic nerve. Primary open-angle glaucoma is the most common form, and it is usually painless with insidious onset. Conventional treatment is focused on lowering intraocular pressure (IOP), the one risk factor that can be modified, which has been demonstrated to protect against further damage to the optic-nerve head. Acupuncture is an ancient treatment which has been found to be beneficial for many ailments, and may reduce IOP. We propose a pilot study to evaluate whether acupuncture is an effective and safe modality for reducing elevated IOP in patients with open angle glaucoma and primary ocular hypertension. Patients with elevated IOP on tonometric measurement (20mmHg < IOP < 30mmHg) will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment. Treatment will last for four-weeks (for a total of 8 treatments), and patients will be evaluated for IOP diurnal curves at 2 weeks (4 treatment), 4 weeks (end of treatment ) and then 4 weeks following the last treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Intraocular Pressure
Keywords
acupuncture, intraocular pressure, glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
acupuncture
Primary Outcome Measure Information:
Title
Intraocular pressure curves.
Secondary Outcome Measure Information:
Title
safety of acupuncture treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients of either gender; age 21 years and older; intraocular pressure equal/greater than 20mmHg, equal/less than 30mmHg; ability to comply with study protocol Exclusion Criteria: patients with secondary or closed-angle glaucoma; patients with a history of laser or other surgical treatment of glaucoma; patients displaying symptoms of depression, anxiety or psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menachem Oberbaum, M.D.
Organizational Affiliation
Shaare Zedek Medical Center, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Ophthalmology, Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel

12. IPD Sharing Statement

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Acupuncture for Elevated Intraocular Pressure

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