<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/NCT04403750</url>
  </required_header>
  <id_info>
    <org_study_id>Technology of RRD treatment</org_study_id>
    <nct_id>NCT04403750</nct_id>
  </id_info>
  <brief_title>Combined Laser-surgical Technology of RRD Treatment</brief_title>
  <official_title>Combined Laser-surgical Technology of Rhegmatogenous Retinal Detachment Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The S.N. Fyodorov Eye Microsurgery State Institution</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The S.N. Fyodorov Eye Microsurgery State Institution</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD&#xD;
      treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study takes place in the S.N. Fyodorov &quot;Eye Microsurgery&quot; Federal State Institution&#xD;
      located in Moscow, Russian Federation.&#xD;
&#xD;
      The study will include 50 patients with rhegmatogenous retinal detachment due to a&#xD;
      horseshoe-tear. In addition to the standard ophthalmological examination, all patients will&#xD;
      undergo wide-field optical coherence tomography to determine the extension and localization&#xD;
      of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step&#xD;
      of laser-surgical treatment. All patients will undergo a combined laser-surgical technology,&#xD;
      which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2)&#xD;
      pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after&#xD;
      retinal attachment.&#xD;
&#xD;
      The patients are going to be followed up for at least 1 year, the main outcome measures are&#xD;
      postoperative primary and final anatomic outcome, BCVA and complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 15, 2018</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 25, 2020</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>Retinal reattachment rate</measure>
    <time_frame>in 1 month after gas resorption</time_frame>
    <description>complete retinal re-attachment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anatomical success</measure>
    <time_frame>3, 6, 12 and 24 months post intervention</time_frame>
    <description>complete retinal re-attachment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>3, 6, 12 and 24 months post intervention</time_frame>
    <description>ETDRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>3, 6, 12 and 24 months post intervention</time_frame>
    <description>Snellen</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Rhegmatogenous Retinal Detachment</condition>
  <arm_group>
    <arm_group_label>Combined laser-surgical technology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combined laser-surgical technology includes 3 steps:&#xD;
Nd-YAG laser excision of the vitreoretinal traction zone&#xD;
Pneumatic retinopexy (10% C3F8)&#xD;
Barrier laser photocoagulation around retinal break after retinal attachment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Combined laser-surgical technology of RRD treatment</intervention_name>
    <description>Nd-YAG laser excision of the vitreoretinal traction zone&#xD;
Pneumatic retinopexy (10% C3F8)&#xD;
barrier laser photocoagulation around retinal break after retinal attachment (2-3 days after pneumatic retinopexy)</description>
    <arm_group_label>Combined laser-surgical technology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock&#xD;
             meridians.&#xD;
&#xD;
          2. Superior retinal break from 9 o'clock to 3 o'clock&#xD;
&#xD;
          3. Single retinal break not greater than 1 clock hours in size&#xD;
&#xD;
          4. Physically and mentally co-operated in post-operative head positioning&#xD;
&#xD;
          5. No (or minimal) proliferative vitreoretinopathy&#xD;
&#xD;
          6. None or mild vitreous hemorrhage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole,&#xD;
             traumas); OR&#xD;
&#xD;
          2. Ocular media opacities&#xD;
&#xD;
          3. Previous ocular surgeries&#xD;
&#xD;
          4. Age &lt;18 years&#xD;
&#xD;
          5. Previous retinal detachment (index eye)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leonid Kryl, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>S.N. Fyodorov Eye Microsurgery State Institution.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mariiam Taevere, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>S.N. Fyodorov Eye Microsurgery State Institution.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexander Doga, Professor</last_name>
    <role>Study Director</role>
    <affiliation>S.N. Fyodorov Eye Microsurgery State Institution.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mariiam Taevere, MD</last_name>
    <phone>+79160173038</phone>
    <email>taeveremr@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leonid Kryl, PhD, MD</last_name>
    <phone>+79163747142</phone>
    <email>doctor-leonid@inbox.ru</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The S.N. Fyodorov Eye Microsurgery State Institution.</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariiam Taevere</last_name>
      <phone>+79160173038</phone>
    </contact>
    <investigator>
      <last_name>Leonid Kryl, PhD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mariiam Taevere, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>https://eyepress.ru/article.aspx?40421</url>
    <description>Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography</description>
  </link>
  <link>
    <url>https://eyepress.ru/article.aspx?30058</url>
    <description>The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment</description>
  </link>
  <reference>
    <citation>Bayzulaeva M.R., Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A. [Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography]. Modern technologies in ophtalmology. 2019 June 25. doi: https://doi.org/10.25276/2312-4911-2019-4-20-23</citation>
  </reference>
  <reference>
    <citation>Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A., Bayzulaeva M.R. [The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment]. Modern technologies in ophtalmology. 2019 March 20. doi: https://doi.org/10.25276/2312-4911-2019-1-363-368</citation>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The S.N. Fyodorov Eye Microsurgery State Institution</investigator_affiliation>
    <investigator_full_name>Taevere M.R</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Detachment</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04403750
org study id: Technology of RRD treatment
nct id: NCT04403750
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Purpose: to assess the efficacy and safety of combined laser-surgical technology of RRD
      treatment
The study takes place in the S.N. Fyodorov "Eye Microsurgery" Federal State Institution
      located in Moscow, Russian Federation.

      The study will include 50 patients with rhegmatogenous retinal detachment due to a
      horseshoe-tear. In addition to the standard ophthalmological examination, all patients will
      undergo wide-field optical coherence tomography to determine the extension and localization
      of the vitreoretinal traction zone. The obtained data will be used to planning the 1st step
      of laser-surgical treatment. All patients will undergo a combined laser-surgical technology,
      which includes 3 steps: 1) Nd-YAG laser excision of the vitreoretinal traction zone 2)
      pneumatic retinopexy (10% C3F8) 3) barrier laser photocoagulation around retinal break after
      retinal attachment.

      The patients are going to be followed up for at least 1 year, the main outcome measures are
      postoperative primary and final anatomic outcome, BCVA and complications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Retinal reattachment rate
time frame: in 1 month after gas resorption
description: complete retinal re-attachment
measure: Anatomical success
time frame: 3, 6, 12 and 24 months post intervention
description: complete retinal re-attachment
measure: Visual acuity
time frame: 3, 6, 12 and 24 months post intervention
description: ETDRS
measure: Visual acuity
time frame: 3, 6, 12 and 24 months post intervention
description: Snellen
arm group label: Combined laser-surgical technology
arm group type: Experimental
description: Combined laser-surgical technology includes 3 steps:
Nd-YAG laser excision of the vitreoretinal traction zone
Pneumatic retinopexy (10% C3F8)
Barrier laser photocoagulation around retinal break after retinal attachment.
intervention type: Procedure
intervention name: Combined laser-surgical technology of RRD treatment
description: Nd-YAG laser excision of the vitreoretinal traction zone
Pneumatic retinopexy (10% C3F8)
barrier laser photocoagulation around retinal break after retinal attachment (2-3 days after pneumatic retinopexy)
arm group label: Combined laser-surgical technology
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Leonid Kryl, PhD, MD
role: Principal Investigator
affiliation: S.N. Fyodorov Eye Microsurgery State Institution.
last name: Mariiam Taevere, MD
role: Principal Investigator
affiliation: S.N. Fyodorov Eye Microsurgery State Institution.
last name: Alexander Doga, Professor
role: Study Director
affiliation: S.N. Fyodorov Eye Microsurgery State Institution.
last name: Mariiam Taevere, MD
phone: +79160173038
email: taeveremr@gmail.com
last name: Leonid Kryl, PhD, MD
phone: +79163747142
email: doctor-leonid@inbox.ru
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Russian Federation
url: https://eyepress.ru/article.aspx?40421
description: Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography
url: https://eyepress.ru/article.aspx?30058
description: The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment
citation: Bayzulaeva M.R., Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A. [Assessment of peripheral vitreoretinal interface structural changes in patients with local rhematogenous retinal detachments by wide-field optical coherent tomography]. Modern technologies in ophtalmology. 2019 June 25. doi: https://doi.org/10.25276/2312-4911-2019-4-20-23
citation: Doga A.V., Shkvorchenko D.O., Kryl L.A., Buryakov D.A., Bayzulaeva M.R. [The assessment of combined laser and microinvasive surgery efficiency in local retinal detachment treatment]. Modern technologies in ophtalmology. 2019 March 20. doi: https://doi.org/10.25276/2312-4911-2019-1-363-368
responsible party type: Principal Investigator
investigator affiliation: The S.N. Fyodorov Eye Microsurgery State Institution
investigator full name: Taevere M.R
investigator title: Principal Investigator
mesh term: Retinal Detachment
sharing ipd: No