Ocular HypertensionOMT4OHTNCT01864642
Effects of a Single OMT on Intraocular Pressure (IOP) in Ocular Hypertenive or Glaucoma Suspect Subjects
A study testing osteopathic manipulative treatment (OMT) in people with Ocular Hypertension and Glaucoma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The hypothesis is that osteopathic manipulative treatment (OMT)will significantly reduce intraocular pressure (IOP) in individuals with ocular hypertension (OHT) and glaucoma suspect patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ocular Hypertension, Glaucoma
- What is being tested?
- osteopathic manipulative treatment (OMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2014
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject inclusion criteria.
- Subjects will be of either sex, age 18 years or older, and of any race or eye color.
- Subjects with confirmed ocular hypertension (OHT) or glaucoma suspects whose IOP was ≥ 20 mmHg at two measurements separated by at least 3 months.
- Subjects who do not have visual field defect(s), as determined by Visual Field Analysis within the last year.
- Subjects who do not have abnormal cupping of the optic nerve head.
- Subjects who do not have narrow angles as determined by gonioscopy (must be at least angle grade 2 to 3; Shaffer Classification Scale) recorded in the subject's patient record or as determined by biomicroscopy.
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- Subjects who have not been treated with ocular hypotensive agents (or, if they have been treated, not for at least the preceding 3 months). In essence, the subjects will have been and be undergoing "watchful waiting" by their eye care practitioner(s) because no definitive diagnosis of glaucoma requiring treatment has been made.
- Subjects must satisfy all informed consent requirements. 8 Subjects whose mean IOP measurements in at least one (1) eye, the same eye(s), must be:
- 9. Greater than or equal to 20 mmHg at the 8 AM time-point on the Screening and Enrollment Visits (1 and 2) and 10. Greater than or equal to 19 mmHg at the 10 AM, 12 Noon, and 4 PM time-points on the Screening and Enrollment Visits (1 and 2).
- -
Who cannot join
- Subjects who have had any traumatic brain injury or head trauma, which resulted in upper-spinal fusion and/or cranial bone surgery, which implanted a metal plate.
- Subjects who have a concurrent diagnosis of cancer or metastatic disease affecting the head and neck.
- Subjects who have been diagnosed with glaucoma or ocular hypertension and whose condition requires medical treatment other than "watchful waiting."
- Subjects who are less than 18 years old.
- Subjects who are lactating, pregnant, or plan to become pregnant in the time planned for the study.
- Subjects who have a history of chronic or recurrent severe inflammatory eye disease (e.g., scleritis, uveitis) in either eye as determined by patient history and/or examination.
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- Subjects who have a history of clinically significant or progressive retinal disease in either eye such as retinal degeneration, diabetic retinopathy, or retinal detachment with permanent field loss as determined by patient history and/or examination.
- Subjects who have a history of serious ocular trauma in either eye within the past six (6) months as determined by patient history and/or examination.
- Subjects who have had intraocular surgery in either eye within the past six (6) months as determined by patient history and/or examination.
- Subjects who have had ocular laser surgery in either eye within the past three (3) months as determined by patient history and/or examination.
- Subjects who have a history of ocular infection or ocular inflammation in either eye within the past three (3) months as determined by patient history and/or examination.
- Subjects who have any abnormality preventing reliable applanation tonometry of either eye (e.g., keratoconus, corneal or conjunctival scarring).
- Subjects who have any abnormality preventing reliable assessment of pupil diameter in either eye (e.g., congenital pupil anomaly, posterior synechiae, anterior cleavage syndrome, afferent defects, prior surgery, etc.).
- Subjects who have less than a thirty (30) days stable dosing regimen before the Screening and Enrollment Visits (Visits 1 and 2) of any non-ocular medications that may affect IOP, administered by any route and used on a chronic basis. These may include, but are not limited to, alpha agonists, beta-blockers, calcium channel blockers, antimuscarinic agents, and phenothiazines.
- Subjects who have other treatments and/or surgeries unrelated to the eye condition scheduled in the time planned for the study.
- Subjects who are allergic to Latex, PABA, Proparacaine, or Fluorescein.
- Subjects who have had prior surgical or laser treatment for the purpose of lowering their IOP.
- Subjects who currently have systemic infections resulting in fever or immunosuppression.
- Subjects who have had previous OMT, chiropractic manipulation, massage, or other forms of manual therapy within the last 2 months.
- Subjects who are unable to give appropriate informed consent due to mental or other limitations.
- Additionally, the Principal Investigator may declare any subject ineligible for a valid medical reason.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Dept of Ophthalmology Clinic
Madison, Wisconsin, 53715
About this study
Official title: A Study of the Effects of a Single Osteopathic Manipulative Treatment (OMT) on Intraocular Pressure (IOP)in Un-medicated Confirmed Ocular Hypertensive (OHT) or Glaucoma Suspect Subjects
The hypothesis is that osteopathic manipulative treatment (OMT)will significantly reduce intraocular pressure (IOP) in individuals with ocular hypertension (OHT) and glaucoma suspect patients.
Read the detailed description
Glaucoma is a leading cause of irreversible blindness in the United States and the world. Approximately 2.8 million Americans have been diagnosed with glaucoma. Based on pilot studies and the clinical experience of the PI, a power analysis indicated that in order to lower IOP by 4 mm Hg 28 subjects would be needed, 14 in the experimental group and 14 in the control/comparator group.
The intervention is OMT. Based on the anatomy of the eye and the dysfunctions underlying primary open angle glaucoma (POAG), the presumed mechanisms are one or the other or a combination of the following. 1) Anatomic: the OMT benefit may occur by the biomechanical restoration of drainage through the trabecular meshwork and Schlemm's canal. 2) Neurologic: the OMT may affect the parasympathetic innervations from the Edinger-Westphal fibers via the cranial nerve III as well as the sympathetic innervations arising in the T1 to T3 levels then via the superior cervical ganglion which then course to the eye.
The OMT protocol takes 25-27 minutes to administer and addresses cranial, cervical, upper body, spinal and sacral structures designed to affect the anatomic, physiologic processes (e.g. lymphatic drainage from the neck and face), neurologic structures (sympathic and parasympathetic) affecting visual processes. A very similar OMT protocol was used in a study on healthy elder and resulted in improved balance and equilibrium. In that study there were no adverse outcomes reported.
The control/comparator subjects will lay on the OMT table for the same 25-27 minutes in the same time periods in which experimental subjects were in the prone, lateral recumbent, and supine positions.
- Conditions
- Ocular Hypertension, Glaucoma
- Being tested
- osteopathic manipulative treatment (OMT)
- 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.
osteopathic manipulative treatment (OMT)Procedure or surgery
osteopathic manipulative treatment (OMT)Procedure or surgery
Also called OMT is a form of manual medicine
OMT is a form of manual medicine performed by osteopathic physicians
| Study group | Role | What they receive |
|---|---|---|
| osteopathic manipulative treatment | Experimental | osteopathic manipulative treatment (OMT) Receives: Procedure: osteopathic manipulative treatment (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Goldman Tonometry
Measured: up to 3 days
Secondary outcomes (1)
pupillometry
Pupillometry measures the pupil size and reactivity to light
Measured: measured on day one and two to assess eligibility, assess on day three at the time of the intervention, then on day 7 as last day of subject participation (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hollis H King, DO, PhD, Principal investigator, Univ Wisconsin Dept of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864642
- Sponsor's protocol ID
- UW IRB 2012-1102
- Acronym
- OMT4OHT
- Status last verified
- Aug 2014
- First submitted
- 20 May 2013
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of a Single Osteopathic Manipulative Treatment (OMT) on Intraocular Pressure (IOP)in Un-medicated Confirmed Ocular Hypertensive (OHT) or Glaucoma Suspect Subjects
- ClinicalTrials.gov ID
- NCT01864642
- Acronym / sponsor ID
- OMT4OHT / UW IRB 2012-1102
- Conditions
- Ocular Hypertension, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 May 2013 (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.
The hypothesis is that osteopathic manipulative treatment (OMT)will significantly reduce intraocular pressure (IOP) in individuals with ocular hypertension (OHT) and glaucoma suspect patients.
Detailed description
Glaucoma is a leading cause of irreversible blindness in the United States and the world. Approximately 2.8 million Americans have been diagnosed with glaucoma. Based on pilot studies and the clinical experience of the PI, a power analysis indicated that in order to lower IOP by 4 mm Hg 28 subjects would be needed, 14 in the experimental group and 14 in the control/comparator group.
The intervention is OMT. Based on the anatomy of the eye and the dysfunctions underlying primary open angle glaucoma (POAG), the presumed mechanisms are one or the other or a combination of the following. 1) Anatomic: the OMT benefit may occur by the biomechanical restoration of drainage through the trabecular meshwork and Schlemm's canal. 2) Neurologic: the OMT may affect the parasympathetic innervations from the Edinger-Westphal fibers via the cranial nerve III as well as the sympathetic innervations arising in the T1 to T3 levels then via the superior cervical ganglion which then course to the eye.
The OMT protocol takes 25-27 minutes to administer and addresses cranial, cervical, upper body, spinal and sacral structures designed to affect the anatomic, physiologic processes (e.g. lymphatic drainage from the neck and face), neurologic structures (sympathic and parasympathetic) affecting visual processes. A very similar OMT protocol was used in a study on healthy elder and resulted in improved balance and equilibrium. In that study there were no adverse outcomes reported.
The control/comparator subjects will lay on the OMT table for the same 25-27 minutes in the same time periods in which experimental subjects were in the prone, lateral recumbent, and supine positions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteopathic manipulative treatment | Experimental | Procedure: osteopathic manipulative treatment (OMT)osteopathic manipulative treatment (OMT) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject inclusion criteria.
- Subjects will be of either sex, age 18 years or older, and of any race or eye color.
- Subjects with confirmed ocular hypertension (OHT) or glaucoma suspects whose IOP was ≥ 20 mmHg at two measurements separated by at least 3 months.
- Subjects who do not have visual field defect(s), as determined by Visual Field Analysis within the last year.
- Subjects who do not have abnormal cupping of the optic nerve head.
Key exclusion criteria (22 listed)
- Subjects who have had any traumatic brain injury or head trauma, which resulted in upper-spinal fusion and/or cranial bone surgery, which implanted a metal plate.
- Subjects who have a concurrent diagnosis of cancer or metastatic disease affecting the head and neck.
- Subjects who have been diagnosed with glaucoma or ocular hypertension and whose condition requires medical treatment other than "watchful waiting."
- Subjects who are less than 18 years old.
- Subjects who are lactating, pregnant, or plan to become pregnant in the time planned for the study.
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 |
|---|---|---|
| osteopathic manipulative treatment (OMT) | Procedure or surgery | osteopathic manipulative treatment |
| osteopathic manipulative treatment (OMT)Also: OMT is a form of manual medicineOMT is a form of manual medicine performed by osteopathic physicians | Procedure or surgery | osteopathic manipulative treatment |
Primary outcome
Intraocular pressure (IOP)
Time frame: up to 3 days
Goldman Tonometry
1 secondary outcome
pupillometry
Time frame: measured on day one and two to assess eligibility, assess on day three at the time of the intervention, then on day 7 as last day of subject participation (up to 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
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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.
Hollis H King, DO, PhD principal investigator
Univ Wisconsin Dept of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic manipulative treatment (OMT) in people with Ocular Hypertension and Glaucoma, run by University of Wisconsin, Madison at 1 site in United States.
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 10 inclusion and 22 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: finished, as of the sponsor's last update on 18 Aug 2014. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (IOP) (time frame: up to 3 days). 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 18 Aug 2014.