<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/NCT02222857</url>
  </required_header>
  <id_info>
    <org_study_id>201406118RIND</org_study_id>
    <nct_id>NCT02222857</nct_id>
  </id_info>
  <brief_title>Prophylactic Laser Photocoagulation and Vitrectomy for Acute Retinal Necrosis</brief_title>
  <official_title>Prophylactic Laser Photocoagulation and Vitrectomy for Acute Retinal Necrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute retinal necrosis (ARN) is a rare infectious retinitis which can potentially lead to&#xD;
      devastating visual outcomes. ARN is diagnosed on the basis of the clinical appearance and&#xD;
      disease course according to the diagnostic criteria proposed by the American Uveitis Society:&#xD;
      (1) one or more foci of retinal necrosis with discrete borders in the peripheral retina; (2)&#xD;
      rapid progression in the absence of antiviral therapy; (3) circumferential spread; (4)&#xD;
      occlusive vasculopathy with arteriolar involvement; and (5) a prominent inflammatory reaction&#xD;
      in the vitreous and anterior chambers.&#xD;
&#xD;
      Herpesvirus infection, especially varicella-zoster virus (VZV) and herpes simplex virus&#xD;
      (HSV), was presumed to be the pathogenic agent in the pathogenesis of ARN. Medical treatment&#xD;
      with systemic antiviral agent had been the base of the therapy of ARN for decades and such&#xD;
      treatment usually result in regression of retinitis.&#xD;
&#xD;
      However, the visual outcome of ARN remains poor. The major causes of poor visual prognosis in&#xD;
      ARN are retinal detachment and optic nerve or macular involvement by ischemic vasculopathy.&#xD;
      Less frequent causes include macular hole formation, macular pucker, or hypotony.&#xD;
      Rhegmatogenous retinal detachment may occur in 75 % of the untreated eyes. It may occur weeks&#xD;
      to months after the onset of inflammation due to delayed formation of retinal breaks, which&#xD;
      result from the combination of necrotic retina and vitreoretinal traction.&#xD;
&#xD;
      Therefore, application of argon laser retinopexy prophylactically posterior to necrotic&#xD;
      retina or prophylactic vitrectomy to reduce inflammatory factors and the vitreoretinal&#xD;
      traction had been used to protect the healthy area from detachment. However, the results were&#xD;
      varied and there is no consensus on the efficacy and indications of those prophylactic&#xD;
      procedures. We had applied the prophylactic procedure in our treatment for ARN. We aim to&#xD;
      access the efficacy of the treatment strategy of ARN and the correlated factors to the&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between 1995 and 2013, the charts of 20 patients (21 eyes) with a clinical diagnosis of ARN&#xD;
      and a complete ophthalmic examination at National Taiwan University Hospital were reviewed.&#xD;
      The study was approved by the Ethics Committee and Institutional Review Board of National&#xD;
      Taiwan University Hospital.&#xD;
&#xD;
      The clinical data recorded included patient demographics, refractive error, lens status, best&#xD;
      corrected visual acuity (BCVA), all treatments and retinal anatomical status. Visual acuities&#xD;
      and examination findings were recorded at presentation and subsequent follow-up periods for&#xD;
      at least 6 months. The area of retina involved was determined by review of retinal drawings&#xD;
      and fundus photos by single reader.&#xD;
&#xD;
      All the patients were admitted for intravenous injection of Acyclovir (30mg/kg/day, in 3&#xD;
      divided doses) for 10-14 days and then shifted to oral Acyclovir (30mg/kg/day) at least for&#xD;
      further 10-14 days. Systemic corticosteroid and Aspirin were also given. Prophylactic laser&#xD;
      photocoagulation was arranged on normal retina to surround the posterior edge of the active&#xD;
      lesions if the media was clear enough to approach. If vitritis persisted without improvement&#xD;
      under systemic antiviral agent or retinal detachment was noted, vitrectomy would be&#xD;
      performed. Visual acuities and retinal anatomical results were recorded during follow-up&#xD;
      after procedures. The visual acuity was converted to logarithm of the minimum angle of&#xD;
      resolution (logMAR) values for statistical analysis.&#xD;
&#xD;
      Statistical analysis The continuous values are expressed as means ± standard deviation (SD).&#xD;
      The differences among the continuous variables were assessed using the Mann-Whitney U test.&#xD;
      Non-continuous variables were analyzed by Fisher's exact test. The level of statistical&#xD;
      significance was set at p &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Best-corrected visual acuity</measure>
    <time_frame>1 year</time_frame>
    <description>Best-corrected visual acuity during follow up and its correlated factors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retinal status</measure>
    <time_frame>1 year</time_frame>
    <description>Retinal status by ophthalmoscopy to see the incidence of retinal detachment and its correlated factors</description>
  </secondary_outcome>
  <enrollment type="Actual">23</enrollment>
  <condition>Acute Retinal Necrosis</condition>
  <condition>Retinal Detachment</condition>
  <condition>Laser Photocoagulation</condition>
  <condition>Vitrectomy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute retinal necrosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ●Patients with clinical diagnosis of acute retinal necrosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of retinal detachment.&#xD;
&#xD;
          -  Patients with history of other causes of severe retinal atrophy or necrosis.&#xD;
&#xD;
          -  HIV positive patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang-Ping Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>April 24, 2018</last_update_submitted>
  <last_update_submitted_qc>April 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute retinal necrosis</keyword>
  <keyword>Retinal detachment</keyword>
  <keyword>Laser photocoagulation</keyword>
  <keyword>Vitrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Retinal Necrosis Syndrome, Acute</mesh_term>
    <mesh_term>Necrosis</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/NCT02222857
org study id: 201406118RIND
nct id: NCT02222857
lead sponsor: 
has dmc: No
Acute retinal necrosis (ARN) is a rare infectious retinitis which can potentially lead to
      devastating visual outcomes. ARN is diagnosed on the basis of the clinical appearance and
      disease course according to the diagnostic criteria proposed by the American Uveitis Society:
      (1) one or more foci of retinal necrosis with discrete borders in the peripheral retina; (2)
      rapid progression in the absence of antiviral therapy; (3) circumferential spread; (4)
      occlusive vasculopathy with arteriolar involvement; and (5) a prominent inflammatory reaction
      in the vitreous and anterior chambers.

      Herpesvirus infection, especially varicella-zoster virus (VZV) and herpes simplex virus
      (HSV), was presumed to be the pathogenic agent in the pathogenesis of ARN. Medical treatment
      with systemic antiviral agent had been the base of the therapy of ARN for decades and such
      treatment usually result in regression of retinitis.

      However, the visual outcome of ARN remains poor. The major causes of poor visual prognosis in
      ARN are retinal detachment and optic nerve or macular involvement by ischemic vasculopathy.
      Less frequent causes include macular hole formation, macular pucker, or hypotony.
      Rhegmatogenous retinal detachment may occur in 75 % of the untreated eyes. It may occur weeks
      to months after the onset of inflammation due to delayed formation of retinal breaks, which
      result from the combination of necrotic retina and vitreoretinal traction.

      Therefore, application of argon laser retinopexy prophylactically posterior to necrotic
      retina or prophylactic vitrectomy to reduce inflammatory factors and the vitreoretinal
      traction had been used to protect the healthy area from detachment. However, the results were
      varied and there is no consensus on the efficacy and indications of those prophylactic
      procedures. We had applied the prophylactic procedure in our treatment for ARN. We aim to
      access the efficacy of the treatment strategy of ARN and the correlated factors to the
      outcomes.
Between 1995 and 2013, the charts of 20 patients (21 eyes) with a clinical diagnosis of ARN
      and a complete ophthalmic examination at National Taiwan University Hospital were reviewed.
      The study was approved by the Ethics Committee and Institutional Review Board of National
      Taiwan University Hospital.

      The clinical data recorded included patient demographics, refractive error, lens status, best
      corrected visual acuity (BCVA), all treatments and retinal anatomical status. Visual acuities
      and examination findings were recorded at presentation and subsequent follow-up periods for
      at least 6 months. The area of retina involved was determined by review of retinal drawings
      and fundus photos by single reader.

      All the patients were admitted for intravenous injection of Acyclovir (30mg/kg/day, in 3
      divided doses) for 10-14 days and then shifted to oral Acyclovir (30mg/kg/day) at least for
      further 10-14 days. Systemic corticosteroid and Aspirin were also given. Prophylactic laser
      photocoagulation was arranged on normal retina to surround the posterior edge of the active
      lesions if the media was clear enough to approach. If vitritis persisted without improvement
      under systemic antiviral agent or retinal detachment was noted, vitrectomy would be
      performed. Visual acuities and retinal anatomical results were recorded during follow-up
      after procedures. The visual acuity was converted to logarithm of the minimum angle of
      resolution (logMAR) values for statistical analysis.

      Statistical analysis The continuous values are expressed as means ± standard deviation (SD).
      The differences among the continuous variables were assessed using the Mann-Whitney U test.
      Non-continuous variables were analyzed by Fisher's exact test. The level of statistical
      significance was set at p < 0.05.
observational model: Case-Only
time perspective: Retrospective
measure: Best-corrected visual acuity
time frame: 1 year
description: Best-corrected visual acuity during follow up and its correlated factors
measure: Retinal status
time frame: 1 year
description: Retinal status by ophthalmoscopy to see the incidence of retinal detachment and its correlated factors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chang-Ping Lin, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Retinal Detachment
mesh term: Retinal Necrosis Syndrome, Acute
mesh term: Necrosis