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

NCT01864642 | Completed

• 1 other identifier: UW IRB 2012-1102
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ocular Hypertension; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  Goldman Tonometry

  up to 3 days

Secondary Outcomes (1)

• pupillometry

  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)

Study Arms (1)

osteopathic manipulative treatment

EXPERIMENTAL

osteopathic manipulative treatment (OMT)

Procedure: osteopathic manipulative treatment (OMT)

Interventions

osteopathic manipulative treatment (OMT) PROCEDURE

osteopathic manipulative treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• \. 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Dept of Ophthalmology Clinic

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Hollis H King, DO, PhD

  Univ Wisconsin Dept of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 29, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

US (1)