<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/NCT03287648</url>
  </required_header>
  <id_info>
    <org_study_id>0004/2017</org_study_id>
    <nct_id>NCT03287648</nct_id>
  </id_info>
  <brief_title>Simultaneous OCT and B-FAF in Eyes With Alteration of the Foveal Contour</brief_title>
  <official_title>Simultaneous Spectral-domain Optical Coherence Tomography and Blue-fundus Autofluorescence in Eyes With Alteration of the Foveal Contour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Molise</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Molise</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some alterations of the foveal contour do not meet the criteria established for the&#xD;
      definition of lamellar macular hole on the basis of optical coherence tomography (OCT).&#xD;
      However, these alterations may show an appearance, on blue fundus autofluorescence (B-FAF)&#xD;
      imaging, reminiscent of lamellar macular hole.&#xD;
&#xD;
      The aim of the study is to evaluate in detail these alterations recording simultaneously OCT&#xD;
      and B-FAF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All images will be collected using the Heidelberg Spectralis system (Heidelberg Engineering,&#xD;
      Heidelberg, Germany) according to the prespecified imaging protocols. Blue-fundus&#xD;
      autofluorescence (excitation wavelength at 488 nm and barrier filter at 500 nm) images and&#xD;
      SD-OCT images will be obtained after pupil dilation.&#xD;
&#xD;
      The OCT recording protocol will consist of a sequence of 37 horizontal sections, spaced&#xD;
      120-µm apart, covering an area of 20° or 30° horizontally by 15° vertically, and a sequence&#xD;
      of 24 radial sections recorded in the high-resolution (HR) mode simultaneously with infrared&#xD;
      (IR) images.&#xD;
&#xD;
      In addition, simultaneous B-FAF/OCT images will be acquired (horizontal, and vertical OCT&#xD;
      sections, centered on the fovea and recorded in the HR mode).&#xD;
&#xD;
      The same OCT/FAF protocol will be used for the study eye and for the fellow eye.&#xD;
&#xD;
      For the study eyes that had been examined in the past, the ''Follow-up'' function will be&#xD;
      used in addition to the prespecified protocol to evaluate if any changes had occurred since&#xD;
      the last scan.&#xD;
&#xD;
      Multiple other morphological characteristics will be analyzed using OCT imaging, including&#xD;
      the status of the posterior cortex, the presence of operculum, the integrity/disruption of&#xD;
      the external limiting membrane (ELM), ellipsoid zone (EZ), and the central and minimal foveal&#xD;
      thickness (CFT and mFT respectively). The latter will be defined as the thinnest part of the&#xD;
      fovea within the foveal pit identified by examining radial scans whereas the former will be&#xD;
      measured in relation to the highest point of the foveal bulge.&#xD;
&#xD;
      All measurements will be performed using the Spectralis built-in manual caliper function at&#xD;
      high magnification after adjusting the scale to 1:1 µm except for CFT, which will be&#xD;
      calculated using the automated ''thickness map'' function of the Heidelberg Eye Explorer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">May 20, 2024</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Relationship between OCT and B-FAF findings</measure>
    <time_frame>6 months</time_frame>
    <description>Measurements of the diameters of the holes expressed in microns, on OCT and B-FAF images respectively, will be collected. The topographic correlation between the area of increased B-FAF signal and the corresponding area on OCT, will be examined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between OCT and B-FAF characteristics and logMAR visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>The relationship between central foveal thickness and logMAR visual acuity will be evaluated</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Lamellar Macular Hole</condition>
  <condition>Lamellar Macular Pseudohole</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>optical coherence tomography and blue-fundus autofluorescence</intervention_name>
    <description>Simultaneous infra-red and optical coherence tomography (cube and radial pattern) centered on the fovea Simultaneous fundus autofluorescence and optical coherence tomography (radial pattern) centered on the fovea</description>
    <other_name>infra-red, color pictures</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        outpatients affected by alteration of the foveal contour associated with increased&#xD;
        autofluorescence signal at the fovea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  alteration of the foveal contour not classifiable as lamellar or pseudo macular hole&#xD;
&#xD;
          -  focal, well-defined increased autofluorescence signal at the fovea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intraretinal cysts not associated with break of the inner retina&#xD;
&#xD;
          -  juxtafoveal telangiectasia&#xD;
&#xD;
          -  ring of increased B-FAF&#xD;
&#xD;
          -  vitelliform and pseudovitelliform lesions&#xD;
&#xD;
          -  history of diabetes, retinal vein occlusion, uveitis, CSR, AMD or any other retinal&#xD;
             -disease potentially associated with intra or subretinal fluid&#xD;
&#xD;
          -  macular drusen&#xD;
&#xD;
          -  history of submacular hemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Roberto dell'Omo, Prof</last_name>
    <phone>00393317120416</phone>
    <email>roberto.dellomo@unimol.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ciro Costagliola, Prof</last_name>
    <phone>00393683589790</phone>
    <email>ciro.costagliola@unimol.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Molise</name>
      <address>
        <city>Campobasso</city>
        <zip>86100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto dell'Omo, Prof</last_name>
      <phone>00393317120416</phone>
      <email>roberto.dellomo@unimol.it</email>
    </contact>
    <contact_backup>
      <last_name>Ciro Costagliola, Prof</last_name>
      <phone>00393683589790</phone>
      <email>ciro.costagliola@unimol.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>January 16, 2021</last_update_submitted>
  <last_update_submitted_qc>January 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Molise</investigator_affiliation>
    <investigator_full_name>Roberto dell'Omo</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>optical coherence tomography</keyword>
  <keyword>blue fundus autofluorescence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Perforations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03287648
org study id: 0004/2017
nct id: NCT03287648
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Some alterations of the foveal contour do not meet the criteria established for the
      definition of lamellar macular hole on the basis of optical coherence tomography (OCT).
      However, these alterations may show an appearance, on blue fundus autofluorescence (B-FAF)
      imaging, reminiscent of lamellar macular hole.

      The aim of the study is to evaluate in detail these alterations recording simultaneously OCT
      and B-FAF.
All images will be collected using the Heidelberg Spectralis system (Heidelberg Engineering,
      Heidelberg, Germany) according to the prespecified imaging protocols. Blue-fundus
      autofluorescence (excitation wavelength at 488 nm and barrier filter at 500 nm) images and
      SD-OCT images will be obtained after pupil dilation.

      The OCT recording protocol will consist of a sequence of 37 horizontal sections, spaced
      120-µm apart, covering an area of 20° or 30° horizontally by 15° vertically, and a sequence
      of 24 radial sections recorded in the high-resolution (HR) mode simultaneously with infrared
      (IR) images.

      In addition, simultaneous B-FAF/OCT images will be acquired (horizontal, and vertical OCT
      sections, centered on the fovea and recorded in the HR mode).

      The same OCT/FAF protocol will be used for the study eye and for the fellow eye.

      For the study eyes that had been examined in the past, the ''Follow-up'' function will be
      used in addition to the prespecified protocol to evaluate if any changes had occurred since
      the last scan.

      Multiple other morphological characteristics will be analyzed using OCT imaging, including
      the status of the posterior cortex, the presence of operculum, the integrity/disruption of
      the external limiting membrane (ELM), ellipsoid zone (EZ), and the central and minimal foveal
      thickness (CFT and mFT respectively). The latter will be defined as the thinnest part of the
      fovea within the foveal pit identified by examining radial scans whereas the former will be
      measured in relation to the highest point of the foveal bulge.

      All measurements will be performed using the Spectralis built-in manual caliper function at
      high magnification after adjusting the scale to 1:1 µm except for CFT, which will be
      calculated using the automated ''thickness map'' function of the Heidelberg Eye Explorer.
observational model: Cohort
time perspective: Cross-Sectional
measure: Relationship between OCT and B-FAF findings
time frame: 6 months
description: Measurements of the diameters of the holes expressed in microns, on OCT and B-FAF images respectively, will be collected. The topographic correlation between the area of increased B-FAF signal and the corresponding area on OCT, will be examined.
measure: Relationship between OCT and B-FAF characteristics and logMAR visual acuity
time frame: 6 months
description: The relationship between central foveal thickness and logMAR visual acuity will be evaluated
intervention type: Diagnostic Test
intervention name: optical coherence tomography and blue-fundus autofluorescence
description: Simultaneous infra-red and optical coherence tomography (cube and radial pattern) centered on the fovea Simultaneous fundus autofluorescence and optical coherence tomography (radial pattern) centered on the fovea
other name: infra-red, color pictures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Roberto dell'Omo, Prof
phone: 00393317120416
email: roberto.dellomo@unimol.it
last name: Ciro Costagliola, Prof
phone: 00393683589790
email: ciro.costagliola@unimol.it
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Molise
investigator full name: Roberto dell'Omo
investigator title: Associate Professor
mesh term: Retinal Perforations
sharing ipd: Undecided