<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/NCT04437446</url>
  </required_header>
  <id_info>
    <org_study_id>OCTA</org_study_id>
    <nct_id>NCT04437446</nct_id>
  </id_info>
  <brief_title>OCT Angiography in the Glaucoma Diagnosis</brief_title>
  <acronym>OCTA</acronym>
  <official_title>OCT Angiography in the Glaucoma Diagnosis : A Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glaucoma is a chronic degenerative disease of the optic nerve. It is the second cause of&#xD;
      blindness worldwide and a frequent cause of irreversible blindness. In 2020, epidemic health&#xD;
      authorities have predicted about 80 million glaucoma patients. Glaucoma can be treated by&#xD;
      topical treatment (eye drops), laser or surgery. A premature diagnosis of glaucoma is very&#xD;
      important to prevent irreversible blindness. Pachymetry, Optical Coherence Tomography (OCT)&#xD;
      and visual fields exams are fundamental for the development of the glaucoma diagnosis. The&#xD;
      severity of glaucoma is defined with Hodapp-Parrish-Andersen visual field criteria. According&#xD;
      to these criteria, glaucoma can be classified as early (with average visual field deviation,&#xD;
      MD, of 0 to -6 dB), moderate (MD of -6 to -12 dB) and severe (MD worse than -12 dB). The&#xD;
      progression of glaucoma is being identified by the visual fields tests, and also by the&#xD;
      progression of alterations in the optic nerve head. The visual fields tests are long and&#xD;
      difficult (30 minutes). It is therefore important to create additional tests and anticipate&#xD;
      the diagnosis, in order to avoid the irreversibility of glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OCT Angiography (OCTA) is a non-invasive technology, marketed since 2014, that uses OCT&#xD;
      with infrared light, with no radiation nor side effects, to evaluate within seconds the&#xD;
      vascularization of the fundus, retina and optic nerve head, which may be useful for the&#xD;
      glaucoma diagnosis. A recent meta-analysis has shown a decrease of the vascular density (DV)&#xD;
      in glaucoma, so that OCTA may be useful in the advanced diagnosis of glaucoma. However, the&#xD;
      VD values obtained were different depending on the device. In addition, no studies with the&#xD;
      OCT Triton (Topcon®) device were considered in the analysis. The authors suggested the&#xD;
      development of dedicated software, which would allow the evaluation of VD with different&#xD;
      devices for a more independent and valid assessment. On the other hand, recent studies show&#xD;
      that the diagnostic capacity of OCTA may be superior to that of OCT, and that OCTA may be&#xD;
      more useful in determining the severity of glaucoma than OCT. It is therefore necessary to&#xD;
      evaluate the additional diagnostic tests whether they are non-invasive and whether it allow&#xD;
      us to give a faster diagnosis.&#xD;
&#xD;
      This study is aimed at comparing the diagnostic utility of OCTA with standard complementary&#xD;
      glaucoma examinations (OCT and CV).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 21, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study is a prospective multicentric and interventional trial that aims to compare the vascular density between patients with glaucoma and patients without glaucoma.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular density between the 2 groups</measure>
    <time_frame>Day1</time_frame>
    <description>This outcome corresponds to percentage of vascularization of the optic papilla measured using OCTA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Papilla supply according to severity of glaucoma</measure>
    <time_frame>Day 1</time_frame>
    <description>This outcome corresponds to the comparison of the percentages of vascular density as a function of the severity of glaucoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of papilla vascularization depending on the regions of the papilla</measure>
    <time_frame>Day 1</time_frame>
    <description>This outcome corresponds to the comparison of the percentages of vascular density as a function of the regions of the papilla (intra-papillary, peripapillary, superior, inferior, nasal, temporal).&#xD;
184/5000 corresponds to the comparison of the percentages of vascular density as a function of the regions of the papilla (intra-papillary, peripapillary, superior, inferior, nasal, temporal).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascularization of different regions of the papilla between case patients and control patients</measure>
    <time_frame>Day 1</time_frame>
    <description>This outcome corresponds to the comparison of the percentages of vascular density of the regions of the papilla between the case patients and the control patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the diagnostic performance of OCTA</measure>
    <time_frame>Day 1</time_frame>
    <description>This outcome corresponds to the comparison of the sensitivity and the specificity of OCTA compared to the additional examinations conventionally carried out within the framework of the diagnosis of glaucoma (OCT and visual fields) within the various regions of the vascular papilla between the case patients and the control patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Case Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The &quot;Case&quot; group corresponds to patients with glaucoma following the clinical criteria for glaucoma:&#xD;
papilla excavation&gt; 5/10 with altered ISNT rule, or neuro-retinal rhyme characteristic of glaucoma, or fiber alterations characteristic of glaucoma.&#xD;
OCT with typical alterations (loss of the layer of nerve fibers or loss of these ganglion cells), loss of fibers typical of glaucoma.&#xD;
Humphrey 24: 2 visual fields produced, reliable and typical of glaucoma.&#xD;
The assignment to the &quot;Cas&quot; group will be carried out by an ophthalmologist specializing in glaucoma according to the following criteria:&#xD;
- The intraocular pressure must be increased before the start of treatment (21 mmHg or more), except in cases of normal pressure glaucoma.&#xD;
The additional examination corresponds to an OCTA alone leading to an extension of the duration of the consultation by 5 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Groupe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Control group corresponds to patients with no glaucoma, no suspicion or history of glaucoma, ocular hypertension, or alterations detected during the ophthalmological consultation.&#xD;
Witnesses will be matched to cases by age (+/- 5 years) and gender.&#xD;
For patients in this group, the additional examinations correspond to a visual field, an OCT and an OCTA leading to an extension of the duration of the consultation by 35 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Case Group</intervention_name>
    <description>The additional examination corresponds to an OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.</description>
    <arm_group_label>Case Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>The additional examinations correspond to:&#xD;
OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.&#xD;
OCT: non-invasive examination, without potential risks, without radiation, using infrared light. The patient must sit in front of a screen and a contact is taken without contact in about ten seconds.&#xD;
Visual field</description>
    <arm_group_label>Control Groupe</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient whose age ≥ 18 years&#xD;
&#xD;
          -  Patient consultant in the ophthalmology department of the Marie-Thérèse Health Center&#xD;
             or the Polyclinique de la Baie&#xD;
&#xD;
          -  French speaking patient&#xD;
&#xD;
          -  Patient affiliated to a health insurance plan&#xD;
&#xD;
          -  Patient having given free, informed and express consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with another ophthalmological pathology or a history of ophthalmological&#xD;
             pathology&#xD;
&#xD;
          -  Patient with a history of ophthalmic surgery except for uncomplicated cataract surgery&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yves LACHKAR, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique de la Baie</name>
      <address>
        <city>Saint-Martin-des-Champs</city>
        <zip>50300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>OCT</keyword>
  <keyword>OCTA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT04437446
org study id: OCTA
nct id: NCT04437446
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Glaucoma is a chronic degenerative disease of the optic nerve. It is the second cause of
      blindness worldwide and a frequent cause of irreversible blindness. In 2020, epidemic health
      authorities have predicted about 80 million glaucoma patients. Glaucoma can be treated by
      topical treatment (eye drops), laser or surgery. A premature diagnosis of glaucoma is very
      important to prevent irreversible blindness. Pachymetry, Optical Coherence Tomography (OCT)
      and visual fields exams are fundamental for the development of the glaucoma diagnosis. The
      severity of glaucoma is defined with Hodapp-Parrish-Andersen visual field criteria. According
      to these criteria, glaucoma can be classified as early (with average visual field deviation,
      MD, of 0 to -6 dB), moderate (MD of -6 to -12 dB) and severe (MD worse than -12 dB). The
      progression of glaucoma is being identified by the visual fields tests, and also by the
      progression of alterations in the optic nerve head. The visual fields tests are long and
      difficult (30 minutes). It is therefore important to create additional tests and anticipate
      the diagnosis, in order to avoid the irreversibility of glaucoma.
The OCT Angiography (OCTA) is a non-invasive technology, marketed since 2014, that uses OCT
      with infrared light, with no radiation nor side effects, to evaluate within seconds the
      vascularization of the fundus, retina and optic nerve head, which may be useful for the
      glaucoma diagnosis. A recent meta-analysis has shown a decrease of the vascular density (DV)
      in glaucoma, so that OCTA may be useful in the advanced diagnosis of glaucoma. However, the
      VD values obtained were different depending on the device. In addition, no studies with the
      OCT Triton (Topcon®) device were considered in the analysis. The authors suggested the
      development of dedicated software, which would allow the evaluation of VD with different
      devices for a more independent and valid assessment. On the other hand, recent studies show
      that the diagnostic capacity of OCTA may be superior to that of OCT, and that OCTA may be
      more useful in determining the severity of glaucoma than OCT. It is therefore necessary to
      evaluate the additional diagnostic tests whether they are non-invasive and whether it allow
      us to give a faster diagnosis.

      This study is aimed at comparing the diagnostic utility of OCTA with standard complementary
      glaucoma examinations (OCT and CV).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The study is a prospective multicentric and interventional trial that aims to compare the vascular density between patients with glaucoma and patients without glaucoma.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Vascular density between the 2 groups
time frame: Day1
description: This outcome corresponds to percentage of vascularization of the optic papilla measured using OCTA.
measure: Papilla supply according to severity of glaucoma
time frame: Day 1
description: This outcome corresponds to the comparison of the percentages of vascular density as a function of the severity of glaucoma.
measure: Difference of papilla vascularization depending on the regions of the papilla
time frame: Day 1
description: This outcome corresponds to the comparison of the percentages of vascular density as a function of the regions of the papilla (intra-papillary, peripapillary, superior, inferior, nasal, temporal).
184/5000 corresponds to the comparison of the percentages of vascular density as a function of the regions of the papilla (intra-papillary, peripapillary, superior, inferior, nasal, temporal).
measure: Vascularization of different regions of the papilla between case patients and control patients
time frame: Day 1
description: This outcome corresponds to the comparison of the percentages of vascular density of the regions of the papilla between the case patients and the control patients.
measure: Evaluation of the diagnostic performance of OCTA
time frame: Day 1
description: This outcome corresponds to the comparison of the sensitivity and the specificity of OCTA compared to the additional examinations conventionally carried out within the framework of the diagnosis of glaucoma (OCT and visual fields) within the various regions of the vascular papilla between the case patients and the control patients.
arm group label: Case Group
arm group type: Experimental
description: The "Case" group corresponds to patients with glaucoma following the clinical criteria for glaucoma:
papilla excavation> 5/10 with altered ISNT rule, or neuro-retinal rhyme characteristic of glaucoma, or fiber alterations characteristic of glaucoma.
OCT with typical alterations (loss of the layer of nerve fibers or loss of these ganglion cells), loss of fibers typical of glaucoma.
Humphrey 24: 2 visual fields produced, reliable and typical of glaucoma.
The assignment to the "Cas" group will be carried out by an ophthalmologist specializing in glaucoma according to the following criteria:
- The intraocular pressure must be increased before the start of treatment (21 mmHg or more), except in cases of normal pressure glaucoma.
The additional examination corresponds to an OCTA alone leading to an extension of the duration of the consultation by 5 minutes.
arm group label: Control Groupe
arm group type: Experimental
description: The Control group corresponds to patients with no glaucoma, no suspicion or history of glaucoma, ocular hypertension, or alterations detected during the ophthalmological consultation.
Witnesses will be matched to cases by age (+/- 5 years) and gender.
For patients in this group, the additional examinations correspond to a visual field, an OCT and an OCTA leading to an extension of the duration of the consultation by 35 minutes.
intervention type: Diagnostic Test
intervention name: Case Group
description: The additional examination corresponds to an OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.
arm group label: Case Group
intervention type: Diagnostic Test
intervention name: Control Group
description: The additional examinations correspond to:
OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.
OCT: non-invasive examination, without potential risks, without radiation, using infrared light. The patient must sit in front of a screen and a contact is taken without contact in about ten seconds.
Visual field
arm group label: Control Groupe
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yves LACHKAR, MD
role: Study Director
affiliation: Fondation Hôpital Saint-Joseph
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Glaucoma