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

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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