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/NCT05993208</url>
    </required_header>
    <id_info>
      <org_study_id>CBOCT&amp;MFERG&amp;VA-VRD</org_study_id>
      <nct_id>NCT05993208</nct_id>
    </id_info>
    <brief_title>Correlation Between OCT and mFERG Findings With VA After Vitrectomy Surgery for Retinal Detachment</brief_title>
    <official_title>Correlation Between Optical Coherence Tomography and Multifocal Electroretinogram Findings With Visual Acuity After Vitrectomy Surgery for Retinal Detachment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>New Valley University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>New Valley University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Correlation between optical coherence tomography and multifocal electroretinogram findings&#xD;
        with visual acuity after vitrectomy surgery for Retinal detachment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Although the anatomical success rate of vitreoretinal surgery has improved over the last&#xD;
        decade, visual results remain compromised? Patients with macula-off retinal detachments (RDs)&#xD;
        can have poor visual recovery, specific color vision defects, or metamorphopsia&#xD;
        postoperatively despite successful retinal reattachment. In these cases, subtle changes in&#xD;
        the foveal structure may be causing visual disturbances that can be difficult to identify&#xD;
        during standard clinical examinations such as slit lamp biomicroscopy or binocular indirect&#xD;
        ophthalmoscopy .reported a possible association between incomplete visual recovery and the&#xD;
        presence of residual subretinal fluid (SRF) postoperatively.&#xD;
  &#xD;
        Optical coherence tomography (OCT) is a non-invasive technique that provides information&#xD;
        about the morphology of the retina, and especially of the macular area in vivo. Some studies&#xD;
        support the idea that OCT determines structural changes in the macula that are correlated&#xD;
        with subjective visual function, including visual acuity (VA) in patients with vitrectomy for&#xD;
        retinal detachment. Additionally, multifocal electroretinogram (m fERG) evaluation can be&#xD;
        helpful in assessing macular function in post-vitrectomy. However, to date, there are&#xD;
        relatively few reports concerning the combined use of OCT and m fERG for the correlation&#xD;
        between retinal morphology and function of the macula in patients with vitrectomy for retinal&#xD;
        detachment surgery. The purpose of our study is to determine whether a significant&#xD;
        correlation exists between the amplitude of m fERG, visual acuity, and the morphological OCT&#xD;
        changes by in the macula after vitrectomy for retinal detachment&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CMT,BCVAand mf-ERG were recoreded in 40 eyes of 40 patintes with vitrectomy for retinal detchament surgery .</measure>
      <time_frame>6 months</time_frame>
      <description>Each 10 um increase in central (CMT) associated by how increase decimal in Best corrected visual acuity and by how nV/deg2 increase multifocal electroretinogram in these eyes .</description>
    </primary_outcome>
    <primary_outcome>
      <measure>BCVA(best corrected visual acuity)</measure>
      <time_frame>6 Month</time_frame>
      <description>Best corrected Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CMT(central macualr thikness ) um</measure>
      <time_frame>6 month</time_frame>
      <description>centeral macualr thikness mesurment using using optical chorent tomgraphgy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mf-ERG amplituide nV/deg2</measure>
      <time_frame>6 month</time_frame>
      <description>multifocal electroretinogram amplituide mesurement using mf-ERG machine</description>
    </primary_outcome>
    <enrollment type="Actual">40</enrollment>
    <condition>Retinal Detachment</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>optical coherence tomography,multifocal electroretinogram. VA measurment</intervention_name>
      <description>retinal photography</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Retrospective observation (analytic) study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with successful vitrectomy for retinal detachment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patients who had vitrectomy for reasons other than retinal detachment surgery&#xD;
  &#xD;
            -  Patients who had done scleral buckle surgery&#xD;
  &#xD;
            -  Patients with media opacity are prevented from doing retina imaging.&#xD;
  &#xD;
            -  Failed or recurrent vitrectomy surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>New Vally University</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>New Valley University</investigator_affiliation>
      <investigator_full_name>Asmaa Kamel Ahmed Hassan</investigator_full_name>
      <investigator_title>lecture</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Retinal Detachment</mesh_term>
      <mesh_term>Dissociative Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05993208
  org study id: CBOCT&MFERG&VA-VRD
  nct id: NCT05993208
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Correlation between optical coherence tomography and multifocal electroretinogram findings
        with visual acuity after vitrectomy surgery for Retinal detachment.
  Although the anatomical success rate of vitreoretinal surgery has improved over the last
        decade, visual results remain compromised? Patients with macula-off retinal detachments (RDs)
        can have poor visual recovery, specific color vision defects, or metamorphopsia
        postoperatively despite successful retinal reattachment. In these cases, subtle changes in
        the foveal structure may be causing visual disturbances that can be difficult to identify
        during standard clinical examinations such as slit lamp biomicroscopy or binocular indirect
        ophthalmoscopy .reported a possible association between incomplete visual recovery and the
        presence of residual subretinal fluid (SRF) postoperatively.
  
        Optical coherence tomography (OCT) is a non-invasive technique that provides information
        about the morphology of the retina, and especially of the macular area in vivo. Some studies
        support the idea that OCT determines structural changes in the macula that are correlated
        with subjective visual function, including visual acuity (VA) in patients with vitrectomy for
        retinal detachment. Additionally, multifocal electroretinogram (m fERG) evaluation can be
        helpful in assessing macular function in post-vitrectomy. However, to date, there are
        relatively few reports concerning the combined use of OCT and m fERG for the correlation
        between retinal morphology and function of the macula in patients with vitrectomy for retinal
        detachment surgery. The purpose of our study is to determine whether a significant
        correlation exists between the amplitude of m fERG, visual acuity, and the morphological OCT
        changes by in the macula after vitrectomy for retinal detachment
  observational model: Case-Only
  time perspective: Retrospective
  measure: CMT,BCVAand mf-ERG were recoreded in 40 eyes of 40 patintes with vitrectomy for retinal detchament surgery .
  time frame: 6 months
  description: Each 10 um increase in central (CMT) associated by how increase decimal in Best corrected visual acuity and by how nV/deg2 increase multifocal electroretinogram in these eyes .
  measure: BCVA(best corrected visual acuity)
  time frame: 6 Month
  description: Best corrected Visual acuity measurement using Snellen's Acuity Chart and will be expressed as decimal notation
  measure: CMT(central macualr thikness ) um
  time frame: 6 month
  description: centeral macualr thikness mesurment using using optical chorent tomgraphgy
  measure: mf-ERG amplituide nV/deg2
  time frame: 6 month
  description: multifocal electroretinogram amplituide mesurement using mf-ERG machine
  intervention type: Diagnostic Test
  intervention name: optical coherence tomography,multifocal electroretinogram. VA measurment
  description: retinal photography
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: New Valley University
  investigator full name: Asmaa Kamel Ahmed Hassan
  investigator title: lecture
  mesh term: Retinal Detachment
  mesh term: Dissociative Disorders
  sharing ipd: Undecided