Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is a measurable change in visual function as a direct result of the application of osteopathic cranial manipulative medicine. The study will also attempt to determine whether any changes noted remain after withdrawal of the treatment.

Official Title
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Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

Conditions
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Visual Function

Intervention / Treatment
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* Procedure: Cranial Manipulation
* Procedure: Sham/Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: free of active ocular or systemic disease refractive error between six diopters of myopia and five diopters of hyperopia with regular astigmatism of any amount normal best-corrected visual acuity at 20/40 or better normal amplitude of accommodation willing to undergo osteopathic cranial manipulative medicine Exclusion Criteria: pregnancy history of previous closed head trauma or brain injury prior cranial manipulative treatment/craniosacral therapy students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cranial manipulation<br>Assessment for cranial strain patterns, followed by indirect cranial manipulation to treat dysfunctions found on assessment, followed by reassessment. Repeated for a total of eight visits no less than one week apart. | Procedure: Cranial Manipulation<br>* Performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.<br>* Other names: Osteopathic Cranial Manipulative Medicine;|
| Sham Comparator: Sham/placebo<br>Assessment for cranial strain patterns, followed a laying on of hands, followed by reassessment. Repeated for a total of eight visits no less than one week apart. | Procedure: Sham/Placebo<br>* A laying on of hands with no actual treatment being performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity | Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart. | Weekly for 16 weeks | 
| Accommodative System Testing | Accommodative amplitude testing using a Donder push-up card. | Weekly for 16 weeks | 
| Local Stereoacuity Testing | Measured by Random Dot E test. | Weekly for 16 weeks | 
| Pupillary Size Testing | Measurement of pupil size (each eye) in bright and dim light. | Weekly for 16 weeks | 
| Vergence System Testing | Assessed by Cover Test with Prism Neutralization and Near Point of Convergence | Weekly for 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cranial manipulation, Visual function