Elevated Intraocular PressurePhase 3NCT00307918
Acupuncture for Elevated Intraocular Pressure
A Phase 3 study testing acupuncture in people with Elevated Intraocular Pressure, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Elevated Intraocular Pressure
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dept. of Ophthalmology, Shaare Zedek Medical Center
Jerusalem, 91031
About this study
Official title: Acupuncture Treatment for Elevated Intraocular Pressure: A Pilot Study
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
- Being tested
- acupuncture
- Keywords
- acupuncture, intraocular pressure, glaucoma
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure curves.
Secondary outcomes (1)
safety of acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startMay 2006
Why it stopped: lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Menachem Oberbaum, M.D., Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307918
- Sponsor's protocol ID
- ACP GL 01 06 CTIL
- Status last verified
- Sep 2007
- First submitted
- 27 Mar 2006
- Last updated
- 2 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment for Elevated Intraocular Pressure: A Pilot Study
- ClinicalTrials.gov ID
- NCT00307918
- Acronym / sponsor ID
- ACP GL 01 06 CTIL
- Conditions
- Elevated Intraocular Pressure
- Keywords
- acupuncture, intraocular pressure, glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patients
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- May 2006
- First posted
- 28 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture | Device | – |
Primary outcome
Intraocular pressure curves.
1 secondary outcome
safety of acupuncture treatment
Results and safety
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Oberbaum, M.D. principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acupuncture in people with Elevated Intraocular Pressure, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure curves.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2007.