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

Primary Purpose

Glaucoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring osteopathic manipulative treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Subject inclusion criteria:

  1. Subjects will be of either sex, age 18 years or older, and of any race or eye color.
  2. 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.
  3. 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.
  4. Subjects who do not have abnormal cupping of the optic nerve head.
  5. 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.
  6. 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).
  7. 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 8:00 AM time-point on the Screening and Enrollment Visits (1 and 2) and
    • Greater than or equal to 19 mmHg at the 5 PM time-points on the Screening and Enrollment Visits (1 and 2).

Subject exclusion criteria:

  1. 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.
  2. Subjects who have a concurrent diagnosis of cancer or metastatic disease affecting the head and neck.
  3. Subjects who are less than 18 years old.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Subjects who have had intraocular surgery in either eye within the past six (6) months as determined by patient history and/or examination.
  9. Subjects who have had ocular laser surgery, which is the use of a laser beam to make a very small hole in the eye tissue (also known as Lasik) in either eye within the past three (3) months as determined by patient history and/or examination.
  10. 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.
  11. Subjects who have any abnormality preventing reliable applanation tonometry of either eye (e.g., keratoconus (a thinning of the cornea), cornea (eyes outer most layer) or conjunctiva (the mucous membrane that covers the front of the eye and lines the inside of the eyelids) scarring.
  12. 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.
  13. Subjects who have other treatments and/or surgeries unrelated to the eye condition scheduled in the time planned for the study.
  14. Subjects who are allergic to Latex, PABA, Proparacaine, or Fluorescein.
  15. Subjects who have had prior surgical or laser treatment for the purpose of lowering their IOP.
  16. Subjects who currently have systemic infections resulting in fever or immunosuppression.
  17. Subjects who have had previous manual medicine or manual therapy with manually guided gentle forces to realign musculoskeletal imbalances or relax strained muscles such as osteopathic manipulative treatment (OMT), chiropractic manipulation, massage within the last 2 months.
  18. Subjects who are unable to give appropriate informed consent due to mental or other limitations.
  19. Additionally, the Principal Investigator may declare any subject ineligible for a valid medical reason.

Sites / Locations

  • Shiley Eye Center, University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Osteopathic Manipulative Treatment (OMT)

No Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Intraocular Pressure Change
All vision data are collected by Hamilton Glaucoma Center trained research staff and physicians. The primary outcome measure, IOP (Goldman tonometry) will be collected and read by two people in the "masked IOP" procedure and the readings will be averaged.

Secondary Outcome Measures

Full Information

First Posted
July 4, 2018
Last Updated
September 30, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03590249
Brief Title
Effects of a Single Osteopathic Manipulative Treatment (OMT) on Intraocular Pressure (IOP) Reduction
Acronym
OMT/IOP
Official Title
Effects of a Single Osteopathic Manipulative Treatment (OMT) on Intraocular Pressure (IOP) Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
osteopathic manipulative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The design of this preliminary pilot trial is a double-masked (blind), randomized, No Treatment-controlled, parallel group design.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The practitioner providing the OMT or No Treatment will not be involved in collecting data for each subject. The practitioner(s) and technicians collecting the data will not be involved in any aspect of the procedure performed (OMT or No Treatment) on the subjects.
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic Manipulative Treatment (OMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Participants in the No Intervention arm will undergo the planned assessments, but not receive any intervention.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Description
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. Treatment will last approximately 45 minutes.
Primary Outcome Measure Information:
Title
Intraocular Pressure Change
Description
All vision data are collected by Hamilton Glaucoma Center trained research staff and physicians. The primary outcome measure, IOP (Goldman tonometry) will be collected and read by two people in the "masked IOP" procedure and the readings will be averaged.
Time Frame
1-day and 1-week post-intervention or no intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject 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. 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: Greater than or equal to 20 mmHg at the 8:00 AM time-point on the Screening and Enrollment Visits (1 and 2) and Greater than or equal to 19 mmHg at the 5 PM time-points on the Screening and Enrollment Visits (1 and 2). Subject 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. Subjects who have had ocular laser surgery, which is the use of a laser beam to make a very small hole in the eye tissue (also known as Lasik) 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 (a thinning of the cornea), cornea (eyes outer most layer) or conjunctiva (the mucous membrane that covers the front of the eye and lines the inside of the eyelids) scarring. 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. Subjects who are allergic to Latex, PABA, Proparacaine, or Fluorescein. Subjects who have had prior surgical or laser treatment for the purpose of lowering their IOP. Subjects who currently have systemic infections resulting in fever or immunosuppression. Subjects who have had previous manual medicine or manual therapy with manually guided gentle forces to realign musculoskeletal imbalances or relax strained muscles such as osteopathic manipulative treatment (OMT), chiropractic manipulation, massage within the last 2 months. Subjects who are unable to give appropriate informed consent due to mental or other limitations. Additionally, the Principal Investigator may declare any subject ineligible for a valid medical reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollis H King, DO, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiley Eye Center, University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

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

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