<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/NCT02201706</url>
  </required_header>
  <id_info>
    <org_study_id>MER201407</org_study_id>
    <secondary_id>MER201407</secondary_id>
    <nct_id>NCT02201706</nct_id>
  </id_info>
  <brief_title>Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye</brief_title>
  <official_title>The Explore Study for the Efficacy and Safety of Multi-electrocoagulation Retinectomy in the Treatment of Retinal Re-detachment in Silicone Oil Filled Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a&#xD;
      complex retinal detachment with poor prognosis.&#xD;
&#xD;
      In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation&#xD;
      retinectomy to reattach the retina. Here the investigators aimed to explore the safety and&#xD;
      efficacy of this new surgical approach&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The relaxing retinectomy is a useful surgery for retinal re-detachment in eyes with silicone&#xD;
      oil filled. However, it has some obvious disadvantages such as the cut of the normal retina&#xD;
      surrounding, leaving a large area of retinal deficiency and significant exposure of retinal&#xD;
      pigment epithelium and choroid membranes.&#xD;
&#xD;
      In this study, we try to apply a modified surgery named Multi-electrocoagulation retinectomy&#xD;
      to re-attach the retina.&#xD;
&#xD;
      Instead of cutting through the proliferated retina directly, this new surgical approach&#xD;
      adopts to cut the retina apart in a honeycomb shape with the help of electrocoagulation.&#xD;
&#xD;
      In this way, we not only relax the traction of the proliferative membranes, but also reserve&#xD;
      the rest retina to cover the RPE layers.&#xD;
&#xD;
      Based on the hypothesis above, we are aiming to explore the safety and efficacy of this new&#xD;
      surgical approach&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>retina reattachment rate</measure>
    <time_frame>3 months after the surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual acuity</measure>
    <time_frame>Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The degree of recurrent PVR</measure>
    <time_frame>Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of intraocular hemorrhage</measure>
    <time_frame>Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">9</enrollment>
  <condition>Retinal Detachment</condition>
  <arm_group>
    <arm_group_label>Multi-electrocoagulation retinectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multi-electrocoagulation retinectomy</intervention_name>
    <description>a modified surgery named &quot;multi-electrocoagulation retinectomy&quot; to re-attach the retina.&#xD;
All the single surgical technique and devices involved in this modified surgery are used commonly in clinic.&#xD;
Base on this, the investigator changes the traditional sequence of these single surgical techniques, and combine them into a new surgical process.</description>
    <arm_group_label>Multi-electrocoagulation retinectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 5-60 years, male or female&#xD;
&#xD;
          2. The primary retinal detachment was caused by ocular trauma, and the vitreous body is&#xD;
             filled with silicone oil now.&#xD;
&#xD;
          3. The presence of inferior retinal re-detachment located among 3-9 o'clock.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The primary retinal detachment was not caused by ocular trauma.&#xD;
&#xD;
          2. Location of the re-detached retina is not mainly in the inferior of the eye.&#xD;
&#xD;
          3. The fundus is unobservable because of severe corneal opacity.&#xD;
&#xD;
          4. The contralateral eye is non-functional&#xD;
&#xD;
          5. Serious heart, lung, liver and kidney dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaofeng Lin, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongshan Ophthalmic Center of Sun yat-sen Universtiy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaofeng Lin, Dr</last_name>
    <phone>02087330000</phone>
    <email>linxiaof@mail.sysu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center of Sun yat-sen Universtiy</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaofeng Lin, Dr</last_name>
      <phone>02087330000</phone>
      <email>linxiaof@mail.sysu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Xiaofeng Lin, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Romaniuk VM. Ocular trauma and other catastrophes. Emerg Med Clin North Am. 2013 May;31(2):399-411. doi: 10.1016/j.emc.2013.02.003.</citation>
    <PMID>23601479</PMID>
  </reference>
  <reference>
    <citation>Han DP, Lewis MT, Kuhn EM, Abrams GW, Mieler WF, Williams GA, Aaberg TM. Relaxing retinotomies and retinectomies. Surgical results and predictors of visual outcome. Arch Ophthalmol. 1990 May;108(5):694-7. doi: 10.1001/archopht.1990.01070070080039.</citation>
    <PMID>2334327</PMID>
  </reference>
  <reference>
    <citation>de Silva DJ, Kwan A, Bunce C, Bainbridge J. Predicting visual outcome following retinectomy for retinal detachment. Br J Ophthalmol. 2008 Jul;92(7):954-8. doi: 10.1136/bjo.2007.131540. Epub 2008 Jun 12. Erratum In: Br J Ophthalmol. 2008 Aug;92(8):1159.</citation>
    <PMID>18556423</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>May 5, 2015</last_update_submitted>
  <last_update_submitted_qc>May 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Xiaofeng Lin</investigator_full_name>
    <investigator_title>vice-president</investigator_title>
  </responsible_party>
  <keyword>Retinal detachment</keyword>
  <keyword>silicone oil</keyword>
  <keyword>retinectomy</keyword>
  <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>
  <!-- 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/NCT02201706
org study id: MER201407
secondary id: MER201407
nct id: NCT02201706
lead sponsor: 
has dmc: Yes
Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a
      complex retinal detachment with poor prognosis.

      In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation
      retinectomy to reattach the retina. Here the investigators aimed to explore the safety and
      efficacy of this new surgical approach
The relaxing retinectomy is a useful surgery for retinal re-detachment in eyes with silicone
      oil filled. However, it has some obvious disadvantages such as the cut of the normal retina
      surrounding, leaving a large area of retinal deficiency and significant exposure of retinal
      pigment epithelium and choroid membranes.

      In this study, we try to apply a modified surgery named Multi-electrocoagulation retinectomy
      to re-attach the retina.

      Instead of cutting through the proliferated retina directly, this new surgical approach
      adopts to cut the retina apart in a honeycomb shape with the help of electrocoagulation.

      In this way, we not only relax the traction of the proliferative membranes, but also reserve
      the rest retina to cover the RPE layers.

      Based on the hypothesis above, we are aiming to explore the safety and efficacy of this new
      surgical approach
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: retina reattachment rate
time frame: 3 months after the surgery
measure: visual acuity
time frame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
measure: Intraocular pressure
time frame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
measure: The degree of recurrent PVR
time frame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
measure: The incidence of intraocular hemorrhage
time frame: Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.
arm group label: Multi-electrocoagulation retinectomy
arm group type: Experimental
description: Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina.
intervention type: Procedure
intervention name: Multi-electrocoagulation retinectomy
description: a modified surgery named "multi-electrocoagulation retinectomy" to re-attach the retina.
All the single surgical technique and devices involved in this modified surgery are used commonly in clinic.
Base on this, the investigator changes the traditional sequence of these single surgical techniques, and combine them into a new surgical process.
arm group label: Multi-electrocoagulation retinectomy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 60 Years
healthy volunteers: No
last name: Xiaofeng Lin, Dr
role: Principal Investigator
affiliation: Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
last name: Xiaofeng Lin, Dr
phone: 02087330000
email: linxiaof@mail.sysu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Romaniuk VM. Ocular trauma and other catastrophes. Emerg Med Clin North Am. 2013 May;31(2):399-411. doi: 10.1016/j.emc.2013.02.003.
PMID: 23601479
citation: Han DP, Lewis MT, Kuhn EM, Abrams GW, Mieler WF, Williams GA, Aaberg TM. Relaxing retinotomies and retinectomies. Surgical results and predictors of visual outcome. Arch Ophthalmol. 1990 May;108(5):694-7. doi: 10.1001/archopht.1990.01070070080039.
PMID: 2334327
citation: de Silva DJ, Kwan A, Bunce C, Bainbridge J. Predicting visual outcome following retinectomy for retinal detachment. Br J Ophthalmol. 2008 Jul;92(7):954-8. doi: 10.1136/bjo.2007.131540. Epub 2008 Jun 12. Erratum In: Br J Ophthalmol. 2008 Aug;92(8):1159.
PMID: 18556423
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xiaofeng Lin
investigator title: vice-president
mesh term: Retinal Detachment
mesh term: Dissociative Disorders