Effect of Osteopathic Cranial Manipulative Medicine on Visual Function
|ClinicalTrials.gov Identifier: NCT02728713|
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Visual Function||Procedure: Cranial Manipulation Procedure: Sham/Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Osteopathic Cranial Manipulative Medicine on Visual Function|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
Experimental: 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.
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 Comparator: 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.
A laying on of hands with no actual treatment being performed.
- 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.
- Accommodative System Testing [ Time Frame: Weekly for 16 weeks ]Accommodative amplitude testing using a Donder push-up card.
- Local Stereoacuity Testing [ Time Frame: Weekly for 16 weeks ]Measured by Random Dot E test.
- Pupillary Size Testing [ Time Frame: Weekly for 16 weeks ]Measurement of pupil size (each eye) in bright and dim light.
- Vergence System Testing [ Time Frame: Weekly for 16 weeks ]Assessed by Cover Test with Prism Neutralization and Near Point of Convergence
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728713
|United States, Florida|
|Nova Southeastern University Davie Health Center|
|Ft. Lauderdale, Florida, United States, 33328|
|Principal Investigator:||Mark Sandhouse, D.O., M.S.||Nova Southeastern University|