Effects of a Single Osteopathic Manipulative Treatment (OMT) on Intraocular Pressure (IOP) Reduction (NCT03590249) | Clinical Trial Compass
UnknownNot Applicable
Effects of a Single Osteopathic Manipulative Treatment (OMT) on Intraocular Pressure (IOP) Reduction
United States28 participantsStarted 2018-07-01
Plain-language summary
Glaucoma is a group of eye diseases, which in most cases produce increased pressure within the eye (intraocular pressure or IOP). Over time, the elevated IOP causes damage to the optic nerve, which can then lead to visual loss and if unchecked, to complete blindness over the course of years. OMT has been shown to affect cranial structure physiology including the possibility of lowering IOP by improving the drainage of intraocular fluid. This randomized study is designed to obtain data to evaluate the effect of OMT on IOP lowering and, if supportive, provide preliminary data for larger clinical trials.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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), glaucoma suspects or diagnosed with primary open-angle glaucoma whose IOP was ≥ 20 mmHg at two measurements separated by at least 3 months. If subject already on IOP lowering medication and goes through the 4 week washout, they must still have initial IOP ≥ 20 mmHg at the Baseline I screening visit.
. Subjects who do not have visual field defect(s), as determined by Visual Field Analysis within the last year such as "blind spots" and other visual image distortions from normal vision.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraocular Pressure Change
Timeframe: 1-day and 1-week post-intervention or no intervention
. Subjects who have not been treated with ocular hypotensive agents (or, if they have been treated, not for at least the preceding 4 weeks before Baseline I Screening).
. Subjects must satisfy all informed consent requirements.
. Subjects whose mean IOP measurements in at least one (1) eye, the same eye(s), must be:
Exclusion criteria
. Subjects who have had any traumatic brain injury or head trauma, which resulted in upper-spinal fusion which requires metal or plastic screws or plates and/or cranial bone surgery, which involves penetration of the cranial bones and/or implantation of a metal plate.
. Subjects who have a concurrent diagnosis of cancer or metastatic disease affecting the head and neck.
. 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, to be confirmed by a urine pregnancy if the woman is still menstruating.
. Subjects who have a history of chronic or recurrent severe inflammatory eye disease (e.g., scleritis - inflammation of the white part of the eye or uveitis - eye redness, pain and blurred vision) 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 (which is the breakdown of the light-sensitive cells in retina), diabetic retinopathy (involves changes to retinal blood vessels that can cause them to bleed or leak fluid), or retinal detachment which is separation of the retina from the layer of cells behind it 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.