Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

Visual Function Clinical Trial

Official title:

Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728713
• Other study ID #: HPD-OST07220201
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: March 30, 2016
• Start date: August 2003
• Est. completion date: November 2005

Study information

• Verified date: March 2016
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Visual Function

Intervention

Procedure:
• Cranial Manipulation
Performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.
• Sham/Placebo
A laying on of hands with no actual treatment being performed.

Locations

Country	Name	City	State
United States	Nova Southeastern University Davie Health Center	Ft. Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	Osteopathic Heritage Foundations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Visual Acuity	Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart.	Weekly for 16 weeks	No
Primary	Accommodative System Testing	Accommodative amplitude testing using a Donder push-up card.	Weekly for 16 weeks	No
Primary	Local Stereoacuity Testing	Measured by Random Dot E test.	Weekly for 16 weeks	No
Primary	Pupillary Size Testing	Measurement of pupil size (each eye) in bright and dim light.	Weekly for 16 weeks	No
Primary	Vergence System Testing	Assessed by Cover Test with Prism Neutralization and Near Point of Convergence	Weekly for 16 weeks	No