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Completed

NCT Number: NCT02728713

Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

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.

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Key information

Conditions

Visual Function

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Southeastern University Davie Health Center

Fort Lauderdale, Florida, 33328, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranial Manipulation

Procedure

Performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.

Other names: Osteopathy in the Cranial Field, Osteopathic Cranial Manipulative Medicine

Sham/Placebo

Procedure

A laying on of hands with no actual treatment being performed.

Primary outcomes

  1. Distance Visual Acuity

    Time frame: Weekly for 16 weeks

    Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart.

  2. Accommodative System Testing

    Time frame: Weekly for 16 weeks

    Accommodative amplitude testing using a Donder push-up card.

  3. Local Stereoacuity Testing

    Time frame: Weekly for 16 weeks

    Measured by Random Dot E test.

  4. Pupillary Size Testing

    Time frame: Weekly for 16 weeks

    Measurement of pupil size (each eye) in bright and dim light.

  5. Vergence System Testing

    Time frame: Weekly for 16 weeks

    Assessed by Cover Test with Prism Neutralization and Near Point of Convergence

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Collaborators

  • Osteopathic Heritage Foundations

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Apr 5, 2016
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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