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

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.

Inclusion Criteria:

Subject inclusion criteria.

1. Subjects will be of either sex, age 18 years or older, and of any race or eye color.

2. Subjects with confirmed ocular hypertension (OHT) or glaucoma suspects whose IOP was
≥ 20 mmHg at two measurements separated by at least 3 months.

3. Subjects who do not have visual field defect(s), as determined by Visual Field
Analysis within the last year.

4. Subjects who do not have abnormal cupping of the optic nerve head.

5. 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.

6. 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.

7. 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).

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Exclusion Criteria:

1. 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.

2. Subjects who have a concurrent diagnosis of cancer or metastatic disease affecting
the head and neck.

3. Subjects who have been diagnosed with glaucoma or ocular hypertension and whose
condition requires medical treatment other than "watchful waiting."

4. Subjects who are less than 18 years old.

5. Subjects who are lactating, pregnant, or plan to become pregnant in the time planned
for the study.

6. 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.

7. 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.

8. 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.

9. Subjects who have had intraocular surgery in either eye within the past six (6)
months as determined by patient history and/or examination.

10. Subjects who have had ocular laser surgery in either eye within the past three (3)
months as determined by patient history and/or examination.

11. 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.

12. Subjects who have any abnormality preventing reliable applanation tonometry of either
eye (e.g., keratoconus, corneal or conjunctival scarring).

13. 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.).

14. 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.

15. Subjects who have other treatments and/or surgeries unrelated to the eye condition
scheduled in the time planned for the study.

16. Subjects who are allergic to Latex, PABA, Proparacaine, or Fluorescein.

17. Subjects who have had prior surgical or laser treatment for the purpose of lowering
their IOP.

18. Subjects who currently have systemic infections resulting in fever or
immunosuppression.

19. Subjects who have had previous OMT, chiropractic manipulation, massage, or other
forms of manual therapy within the last 2 months.

20. Subjects who are unable to give appropriate informed consent due to mental or other
limitations.

21. Additionally, the Principal Investigator may declare any subject ineligible for a
valid medical reason.

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