Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

Not Applicable

Completed

• Conditions: Visual Function
• Interventions: Procedure: Cranial Manipulation; Procedure: Sham/Placebo

• Registration Number: NCT02728713
• Lead Sponsor: Nova Southeastern University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2014-04-03
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-30
• Last Update Submitted: 2016-03-30
• Study First Posted: 2016-04-05
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cranial manipulation	Cranial Manipulation	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.
Sham/placebo	Sham/Placebo	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nova Southeastern University Davie Health Center; 🇺🇸 Ft. Lauderdale, Florida, United States