What side effects are associated with this type of intervention?

Common treatments for glaucoma that improve the drainage of intraocular fluid include medications like prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors. Prostaglandin analogs can cause side effects such as eye redness, eyelash growth, and changes in iris color. Beta-blockers may lead to systemic effects like bradycardia, hypotension, and respiratory issues. Alpha agonists can cause dry mouth, fatigue, and allergic reactions. Carbonic anhydrase inhibitors might result in frequent urination, tingling in the extremities, and gastrointestinal disturbances. These treatments aim to lower IOP and prevent optic nerve damage.

What prior FDA approvals exist?

FDA-approved treatments for glaucoma primarily aim to reduce intraocular pressure by improving the drainage of intraocular fluid or decreasing its production. Common treatments include prostaglandin analogs (e.g., latanoprost), beta-blockers (e.g., timolol), alpha agonists (e.g., brimonidine), and carbonic anhydrase inhibitors (e.g., dorzolamide). Additionally, surgical procedures like trabeculectomy and laser therapies such as selective laser trabeculoplasty (SLT) are used to enhance fluid outflow. While Osteopathic Manipulative Treatment (OMT) is being studied for its potential to improve fluid drainage and lower IOP, it is not yet an FDA-approved treatment for glaucoma.

What other types of research exist?

Promising novel alternatives to OMT for glaucoma patients include minimally invasive glaucoma surgeries (MIGS) such as the iStent, Hydrus Microstent, and Xen Gel Stent, which improve aqueous humor outflow. Additionally, new pharmacological agents like Rho kinase inhibitors (e.g., netarsudil) and combination therapies (e.g., latanoprostene bunod) have shown effectiveness in lowering IOP.

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Behavioural Intervention

Osteopathic Manipulative Treatment for Glaucoma (OMT/IOP Trial)

N/A

Waitlist Available

Led By Hollis H King, DO, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-day and 1-week post-intervention or no intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a hands-on therapy called Osteopathic Manipulative Treatment (OMT) can help lower eye pressure in patients with high eye pressure or glaucoma. The therapy involves manual adjustments that may improve fluid drainage in the eye. The study aims to see if this therapy can significantly reduce eye pressure.

Who is the study for?

Adults 18+ with ocular hypertension, glaucoma suspects, or primary open-angle glaucoma with IOP ≥20 mmHg. Candidates must not have visual field defects, abnormal optic nerve cupping, narrow angles in the eye, recent ocular surgery or trauma, and should not be on IOP lowering meds for at least 4 weeks prior.

What is being tested?

The study tests if Osteopathic Manipulative Treatment (OMT) can lower intraocular pressure (IOP) in patients with high eye pressure related to glaucoma. It's a randomized trial aiming to provide data that could lead to larger trials if results are positive.

What are the potential side effects?

While specific side effects of OMT are not detailed here, it generally involves manual therapy which may cause discomfort or minor pain post-treatment. Uncommonly there might be headaches or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-day and 1-week post-intervention or no intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-day and 1-week post-intervention or no intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-day and 1-week post-intervention or no intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intraocular Pressure Change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Osteopathic Manipulative Treatment (OMT)Experimental Treatment1 Intervention

Osteopathic manipulation involves a number of different manual (hands-on) techniques. These include muscle inhibition (applying pressure to a muscle to induce relaxation); myofascial release (applying pressure to the fascia and moving it toward/away from a strain); muscle energy stretch (contraction of a stretching muscle); counterstrain (shortening a strained muscle); facilitated positional release (moving a vertebra into a restriction and applying a gentle compression); osteopathy in the cranial field (balancing the cranial tissue); balanced ligamentous tension/ligamentous articular strain (moving a joint into ease to release tension in the ligament); one or all of these techniques may be used. Participants will be positioned on an exam table supine, seated, lateral decubitus, prone, or in their position of greatest comfort for the procedure.

Group II: No InterventionActive Control1 Intervention

Participants in the No Intervention arm will undergo the planned assessments, but not receive any intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osteopathic Manipulative Treatment

2008

Completed Phase 4

~2570

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent optic nerve damage. This can be achieved through medications like prostaglandin analogs, which increase the outflow of aqueous humor, and beta-blockers, which reduce aqueous humor production. Additionally, surgical procedures such as trabeculectomy and laser therapy can enhance fluid drainage from the eye. Osteopathic Manipulative Treatment (OMT) is being studied for its potential to improve intraocular fluid drainage, thereby lowering IOP. Effective management of IOP is crucial for glaucoma patients as it helps to prevent progressive vision loss and potential blindness.