Acupuncture for Elevated Intraocular Pressure

NCT00307918 | Terminated Phase 3

• 1 other identifier: ACP GL 01 06 CTIL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Intraocular Pressure

Keywords

acupuncture, intraocular pressure, glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure curves.

Secondary Outcomes (1)

• safety of acupuncture treatment

Interventions

acupuncture DEVICE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Dept. of Ophthalmology, Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Menachem Oberbaum, M.D.

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 28, 2006
• Study Start: May 1, 2006
• Last Updated: October 2, 2007

Record last verified: 2007-09

Locations

IL (1)