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Acupuncture for Elevated Intraocular Pressure

This study has been terminated.
(lack of patients)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00307918
First received: March 27, 2006
Last updated: September 30, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Elevated Intraocular Pressure
Device: acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture Treatment for Elevated Intraocular Pressure: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Intraocular pressure curves.

Secondary Outcome Measures:
  • safety of acupuncture treatment

Estimated Enrollment: 10
Study Start Date: May 2006
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307918

Locations
Israel
Dept. of Ophthalmology, Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00307918     History of Changes
Other Study ID Numbers: ACP GL 01 06 CTIL
Study First Received: March 27, 2006
Last Updated: September 30, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
acupuncture, intraocular pressure, glaucoma

ClinicalTrials.gov processed this record on November 25, 2014