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<docDscr>
  <citation>
    <titlStmt>
      <titl>Risk factors for primary open-angle glaucoma in subjects with ocular hypertension</titl>
      <IDNo>FRESH-PEF99-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="PFIZER (FRANCE)" role="">Sylvie TROY</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Risk factors for primary open-angle glaucoma in subjects with ocular hypertension            </titl>
      <altTitl>
                    PhotoGRAF                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF99-en            </IDNo>
      <IDNo agency="PEF">
                    99                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF99                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Sylvie TROY                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="PFIZER (FRANCE)">
        <ExtLink title="ROR" URI="https://ror.org/02c9yny10" role="organisation id"/>
        <ExtLink title="SIREN" URI="433623550" role="organisation id"/>
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      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            PFIZER (FRANCE)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="PFIZER (FRANCE)" email="sylvie.troy@pfizer.com">
                    Sylvie;TROY
                                            <ExtLink title="ROR" URI="https://ror.org/02c9yny10" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="433623550" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    risk factors glaucoma</keyword>
      <topcClas vocab="health theme">
                        Ophthalmology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/621ef1ce-2ebd-43d9-a6c7-ecd962d27269"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009885"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Glaucoma                                            </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Environmental determinants: Other                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants: Employment                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Main: - Evaluate the differences between the cases afflicted with primary open-angle glaucoma (POAG) and the controls afflicted with isolated ocular hypertension (OHT) concerning the potential risk factors, including sociodemographic factors, systemic diseases and treatments in progress, family antecedents of glaucoma, the duration of the disease, the factors linked to the eye, nutritional factors and the exposure to environmental neurotoxic compounds. Secondary: - Derive a predictive function by using the significant risk factors, in such a way as to assist ophthalmologists in classifying patients having a hypertonia with a high risk of developing glaucoma</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2006-01-01"/>
      <collDate event="end" date="2008-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">For the cases: - Male or female aged 40 years or older; - Patients with a diagnosed POAG, confirmed by a structural and function degradation; - Patients for whom a IOP &gt; 21 mm Hg was recorded at one time in the evolution of the disease.  For the controls - Male or female paired with the age of the case (± 2 years); - Patients having an IOP &gt; 21 mm Hg on the day of the examination and/or a hypotonisant treatment; - Patients with a visual acuity with optimal correction higher than 5/10; - Patients with no anomaly in the visual field characteristic of glaucoma.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>BNF</standardName>
        </standard>
      </standardsCompliance>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Case-control study                    </notes>
    <anlyInfo>
      <respRate>391</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
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