Effects of a Single OMT on Intraocular Pressure (IOP) in Ocular

Status Completed

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01864642
Study type	Interventional
Source	University of Wisconsin, Madison
Contact
Status	Completed
Phase	N/A
Start date	July 2013
Completion date	June 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of a Single OMT on Intraocular Pressure (IOP) in Ocular Hypertenive or Glaucoma Suspect Subjects — OMT4OHT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms