Effects of a Single Osteopathic Manipulative Treatment (OMT) on Intraocular Pressure (IOP) Reduction

Summary

Participation Requirements

Description

The design of this preliminary pilot trial to be conducted is a double-masked (blind), randomized, No Treatment-controlled, parallel group design to determine the IOP-lowering efficacy and safety of a single osteopathic manipulative treatment (OMT) on intraocular pressure (IOP) in un-medicated confi...

The design of this preliminary pilot trial to be conducted is a double-masked (blind), randomized, No Treatment-controlled, parallel group design to determine the IOP-lowering efficacy and safety of a single osteopathic manipulative treatment (OMT) on intraocular pressure (IOP) in un-medicated confirmed ocular hypertensive (OHT), glaucoma suspect, or subjects who have been diagnosed with glaucoma but who have gone through a medically supervised medication washout period or 4 weeks. Potential subjects responding to recruitment who are currently on IOP lowering medication will be prescreened and if interested in proceeding will undergo a 4 week medication washout period. Potential subjects not on IOP lowering medication will proceed directly to the Baseline screening visit. All subjects will be seen for a Baseline Screening Visit followed by a second Baseline Enrollment Visit, during which subjects must satisfy all inclusion criteria and their IOP must qualify in at least one (1) eye, the same eye, at all time points. Qualified subjects will be scheduled for a Study Day 3 Visit. Subjects whose IOP still qualifies at the Visit 3 time point will be randomized in a 1:1 ratio to receive OMT or No Treatment followed by IOP measurements and +7.5 HR (4 PM [± 1 hour]) post-OMT or No Treatment. Follow-up visits will be conducted at Visit 4 (1 day following OMT vs No Treatment), and Visit 5 (1 week following OMT vs No Treatment). Both Visit 4 and Visit 5 will have IOP measured twice.

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