xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05990036</url>
    </required_header>
    <id_info>
      <org_study_id>2022-1225-EXP</org_study_id>
      <nct_id>NCT05990036</nct_id>
    </id_info>
    <brief_title>The Outcome of Sports Vision Training on Collegiate Softball Players</brief_title>
    <official_title>The Outcome of Sports Vision Training on Collegiate Softball Players</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of the Incarnate Word</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of the Incarnate Word</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To investigate the outcomes of sports vision enhancement training on softball players,&#xD;
        specifically the visual skills and visual function. This will help to develop and hone best&#xD;
        practice methods for future research as well as training protocols for athletes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After informed consent is given by each participant, they will go through a pre-training&#xD;
        evaluation at the Sports Vision Clinic at University Incarnate Word. The evaluation will&#xD;
        include a Senaptec Sensory station evaluation of 10 skills, 1) visual acuity 2) contrast&#xD;
        sensitivity 3) depth perception 4) near far quickness 5) perception span 6) multiple object&#xD;
        tracking 7) reaction time 8) target capture 9) eye hand coordination 10) go/No go. Other&#xD;
        skills will be evaluated and re-measured using different types of equipment for better&#xD;
        reliability. 11) visual acuity using Rabin Super vision 12) contrast sensitivity using&#xD;
        Pelli-Robson and Rabin Super vision 13) accommodative facility 14) reaction time on&#xD;
        Dynavision 15) depth perception on the Howard-Dolman, Randot and Automated Vision Tester 16)&#xD;
        vergence ranges 17) accommodative amplitude. At the first evaluation each participant will&#xD;
        also be asked to complete an entering questionnaire, and at the last evaluation each&#xD;
        participate will be asked to complete an exit questionnaire.&#xD;
  &#xD;
        The above-mentioned evaluation of 17 items, will be given to each participant pre-training&#xD;
        protocol, post-training protocol and once more after a washout period of 5 weeks.&#xD;
  &#xD;
        The training protocol will consist of once weekly training sessions 45 minutes in duration.&#xD;
        Every participant will receive the same training protocol the only variation will be level of&#xD;
        advancement, some athletes will advance at different rates onto more complex levels of each&#xD;
        activity. This is to allow continued improvement of the athletes and maintain motivation.&#xD;
        Each training session will consist of the following activities 1) Brock string to improve&#xD;
        vergence accuracy and depth perception; 2) Senaptec Strobe glasses while performing toss and&#xD;
        catch, to improve concentration and visualization; 3) Eye Metrix double eye speed scanning,&#xD;
        activities using a number board, aimed at collecting visual information quickly and&#xD;
        accurately; 4) Senaptec Synchrony activities to improve anticipation and timing; 5) Senaptec&#xD;
        Sensory Station Near Far, focus and concentration activities to improve eye accommodation&#xD;
        accuracy; 6) Dynavision activities to improve reaction time, eye-hand coordination, and&#xD;
        central-peripheral processing speeds; 7) Sports Vision Trainer Go/No go activities to improve&#xD;
        low contrast and go/ no go decision making; 8) Senaptec Sensory Station spatial memory&#xD;
        activities to improve memory span and peripheral awareness. Each activity will be performed&#xD;
        twice.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 15, 2022</start_date>
    <completion_date type="Actual">January 15, 2023</completion_date>
    <primary_completion_date type="Actual">January 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Prospective single cohort with no control group</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Target accuracy</measure>
      <time_frame>Change from baseline at pre-evaluation week 1; to post evaluation at week 12</time_frame>
      <description>An evaluation to compare how many buttons pressed on Dynavision in one minute to the baseline performed at the study onset.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reaction time</measure>
      <time_frame>Change from baseline at pre-evaluation week 1; to post evaluation at week 12</time_frame>
      <description>An evaluation to compare average reaction time of buttons pressed on Dynavision in one minute to the baseline performed at the study onset.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vergence ranges</measure>
      <time_frame>Change from baseline at pre-evaluation week 1; to post evaluation at week 12</time_frame>
      <description>An evaluation to compare vergences ranges to the baseline performed at the study onset measured by using free space prism ranges distance and near.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diminished skills; such as Target accuracy, reaction time, vergences ranges.</measure>
      <time_frame>Change from post evaluation at week 12 compared to final washout evaluation at week 18.</time_frame>
      <description>To see if 5-6 weeks of not training diminishes visual skills trained.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">23</enrollment>
    <condition>Athletic Performance</condition>
    <arm_group>
      <arm_group_label>Sports vision participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women softball team participating in a sports vision training program</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sports vision enhancement training curriculum</intervention_name>
      <description>A curriculum of 8 sports vision training procedures applied during women's collegiate softball team training. The training protocol consists of once weekly training sessions, 45 minutes in duration.</description>
      <arm_group_label>Sports vision participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Member of the University women's softball team&#xD;
  &#xD;
            -  Pregnancy allowable&#xD;
  &#xD;
            -  Good academic standing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of epilepsy&#xD;
  &#xD;
            -  History of seizures&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kimberly Woideck, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of the Incarnate Word</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of the Incarnate Word</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78209</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Zwierko T, Puchalska-Niedbal L, Krzepota J, Markiewicz M, Wozniak J, Lubinski W. The Effects of Sports Vision Training on Binocular Vision Function in Female University Athletes. J Hum Kinet. 2015 Dec 30;49:287-96. doi: 10.1515/hukin-2015-0131. eCollection 2015 Dec 22.</citation>
      <PMID>26925183</PMID>
    </reference>
    <reference>
      <citation>Kutzner BL, Ring M, Michelson G. [Binocular vision training for professional athletes]. Ophthalmologie. 2022 Jul;119(7):721-729. doi: 10.1007/s00347-022-01574-x. Epub 2022 Feb 2. German.</citation>
      <PMID>35107596</PMID>
    </reference>
    <reference>
      <citation>Kirscher DW. Sports vision training procedures. Optom Clin. 1993;3(1):171-82.</citation>
      <PMID>8324323</PMID>
    </reference>
    <reference>
      <citation>Zimmerman AB, Lust KL, Bullimore MA. Visual acuity and contrast sensitivity testing for sports vision. Eye Contact Lens. 2011 May;37(3):153-9. doi: 10.1097/ICL.0b013e31820d12f4.</citation>
      <PMID>21378574</PMID>
    </reference>
    <reference>
      <citation>Formenti D, Duca M, Trecroci A, Ansaldi L, Bonfanti L, Alberti G, Iodice P. Perceptual vision training in non-sport-specific context: effect on performance skills and cognition in young females. Sci Rep. 2019 Dec 10;9(1):18671. doi: 10.1038/s41598-019-55252-1.</citation>
      <PMID>31822740</PMID>
    </reference>
    <reference>
      <citation>Laby DM, Appelbaum LG. Review: Vision and On-field Performance: A Critical Review of Visual Assessment and Training Studies with Athletes. Optom Vis Sci. 2021 Jul 1;98(7):723-731. doi: 10.1097/OPX.0000000000001729.</citation>
      <PMID>34328451</PMID>
    </reference>
    <reference>
      <citation>Hinman SK, Smith KB, Quillen DM, Smith MS. Exercise in Pregnancy: A Clinical Review. Sports Health. 2015 Nov-Dec;7(6):527-31. doi: 10.1177/1941738115599358. Epub 2015 Aug 4.</citation>
      <PMID>26502446</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sports</keyword>
    <keyword>Vision</keyword>
    <keyword>Training</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 4, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT05990036/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 4, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT05990036/SAP_001.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 4, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT05990036/ICF_002.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05990036
  org study id: 2022-1225-EXP
  nct id: NCT05990036
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To investigate the outcomes of sports vision enhancement training on softball players,
        specifically the visual skills and visual function. This will help to develop and hone best
        practice methods for future research as well as training protocols for athletes.
  After informed consent is given by each participant, they will go through a pre-training
        evaluation at the Sports Vision Clinic at University Incarnate Word. The evaluation will
        include a Senaptec Sensory station evaluation of 10 skills, 1) visual acuity 2) contrast
        sensitivity 3) depth perception 4) near far quickness 5) perception span 6) multiple object
        tracking 7) reaction time 8) target capture 9) eye hand coordination 10) go/No go. Other
        skills will be evaluated and re-measured using different types of equipment for better
        reliability. 11) visual acuity using Rabin Super vision 12) contrast sensitivity using
        Pelli-Robson and Rabin Super vision 13) accommodative facility 14) reaction time on
        Dynavision 15) depth perception on the Howard-Dolman, Randot and Automated Vision Tester 16)
        vergence ranges 17) accommodative amplitude. At the first evaluation each participant will
        also be asked to complete an entering questionnaire, and at the last evaluation each
        participate will be asked to complete an exit questionnaire.
  
        The above-mentioned evaluation of 17 items, will be given to each participant pre-training
        protocol, post-training protocol and once more after a washout period of 5 weeks.
  
        The training protocol will consist of once weekly training sessions 45 minutes in duration.
        Every participant will receive the same training protocol the only variation will be level of
        advancement, some athletes will advance at different rates onto more complex levels of each
        activity. This is to allow continued improvement of the athletes and maintain motivation.
        Each training session will consist of the following activities 1) Brock string to improve
        vergence accuracy and depth perception; 2) Senaptec Strobe glasses while performing toss and
        catch, to improve concentration and visualization; 3) Eye Metrix double eye speed scanning,
        activities using a number board, aimed at collecting visual information quickly and
        accurately; 4) Senaptec Synchrony activities to improve anticipation and timing; 5) Senaptec
        Sensory Station Near Far, focus and concentration activities to improve eye accommodation
        accuracy; 6) Dynavision activities to improve reaction time, eye-hand coordination, and
        central-peripheral processing speeds; 7) Sports Vision Trainer Go/No go activities to improve
        low contrast and go/ no go decision making; 8) Senaptec Sensory Station spatial memory
        activities to improve memory span and peripheral awareness. Each activity will be performed
        twice.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective single cohort with no control group
  primary purpose: Other
  masking: None (Open Label)
  measure: Target accuracy
  time frame: Change from baseline at pre-evaluation week 1; to post evaluation at week 12
  description: An evaluation to compare how many buttons pressed on Dynavision in one minute to the baseline performed at the study onset.
  measure: Reaction time
  time frame: Change from baseline at pre-evaluation week 1; to post evaluation at week 12
  description: An evaluation to compare average reaction time of buttons pressed on Dynavision in one minute to the baseline performed at the study onset.
  measure: Vergence ranges
  time frame: Change from baseline at pre-evaluation week 1; to post evaluation at week 12
  description: An evaluation to compare vergences ranges to the baseline performed at the study onset measured by using free space prism ranges distance and near.
  measure: Diminished skills; such as Target accuracy, reaction time, vergences ranges.
  time frame: Change from post evaluation at week 12 compared to final washout evaluation at week 18.
  description: To see if 5-6 weeks of not training diminishes visual skills trained.
  arm group label: Sports vision participants
  arm group type: Experimental
  description: Women softball team participating in a sports vision training program
  intervention type: Other
  intervention name: Sports vision enhancement training curriculum
  description: A curriculum of 8 sports vision training procedures applied during women's collegiate softball team training. The training protocol consists of once weekly training sessions, 45 minutes in duration.
  arm group label: Sports vision participants
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kimberly Woideck, DO
  role: Principal Investigator
  affiliation: University of the Incarnate Word
  facility: 
  country: United States
  citation: Zwierko T, Puchalska-Niedbal L, Krzepota J, Markiewicz M, Wozniak J, Lubinski W. The Effects of Sports Vision Training on Binocular Vision Function in Female University Athletes. J Hum Kinet. 2015 Dec 30;49:287-96. doi: 10.1515/hukin-2015-0131. eCollection 2015 Dec 22.
  PMID: 26925183
  citation: Kutzner BL, Ring M, Michelson G. [Binocular vision training for professional athletes]. Ophthalmologie. 2022 Jul;119(7):721-729. doi: 10.1007/s00347-022-01574-x. Epub 2022 Feb 2. German.
  PMID: 35107596
  citation: Kirscher DW. Sports vision training procedures. Optom Clin. 1993;3(1):171-82.
  PMID: 8324323
  citation: Zimmerman AB, Lust KL, Bullimore MA. Visual acuity and contrast sensitivity testing for sports vision. Eye Contact Lens. 2011 May;37(3):153-9. doi: 10.1097/ICL.0b013e31820d12f4.
  PMID: 21378574
  citation: Formenti D, Duca M, Trecroci A, Ansaldi L, Bonfanti L, Alberti G, Iodice P. Perceptual vision training in non-sport-specific context: effect on performance skills and cognition in young females. Sci Rep. 2019 Dec 10;9(1):18671. doi: 10.1038/s41598-019-55252-1.
  PMID: 31822740
  citation: Laby DM, Appelbaum LG. Review: Vision and On-field Performance: A Critical Review of Visual Assessment and Training Studies with Athletes. Optom Vis Sci. 2021 Jul 1;98(7):723-731. doi: 10.1097/OPX.0000000000001729.
  PMID: 34328451
  citation: Hinman SK, Smith KB, Quillen DM, Smith MS. Exercise in Pregnancy: A Clinical Review. Sports Health. 2015 Nov-Dec;7(6):527-31. doi: 10.1177/1941738115599358. Epub 2015 Aug 4.
  PMID: 26502446
  responsible party type: Sponsor
  sharing ipd: No
  provided document: 
  provided document: 
  provided document: 