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23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical

Primary Purpose

Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
23 PARS PLANA VITRECTOMY
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring retina, silicone, laser, break, vitrectomy

Eligibility Criteria

23 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • they had retinal detachment,
  • moderate degrees of PVR
  • PVR ≥ Grade C
  • previous buckle surgery
  • pseudophakia.

Exclusion Criteria:

  • the retinal tear was greater than 90 degrees
  • presence of intravitreal foreign body
  • previous vitrectomy done before
  • if follow-up data were unavailable for a minimum follow-up of 6 months following the final retinal procedure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Non retinal detachment group

    retinal detachment group

    Arm Description

    35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.

    15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.

    Outcomes

    Primary Outcome Measures

    success rate
    success rate after first RD surgery and silicone oil removal
    The failure rate
    The failure rate after silicone oil removal
    number of surgical interference
    numbers of vitrectomies done after silicone oil removal

    Secondary Outcome Measures

    lower retinal breaks
    The rate of lower retinal breaks in RD group versus the rate of lower retinal breaks in NRD group was

    Full Information

    First Posted
    February 19, 2020
    Last Updated
    February 20, 2020
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04280770
    Brief Title
    23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical
    Official Title
    Surgical Techniques for Epiretinal Membrane Removal in Pars Plana Vitrectomy: A Comparative Study Between 20-Gauge and 23-Gauge Vitrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 30, 2009 (Actual)
    Primary Completion Date
    March 11, 2013 (Actual)
    Study Completion Date
    March 30, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objective: to evaluate anatomical and visual outcomes of 23-gauge vitrectomy for retinal detachment with silicone oil injection in fifty cases. The rate of recurrence, the incidence of proliferative vitreoretinopathy (PVR) and the value of risk factors. Participants and Methods: fifty cases with RD with mixture of epiretinal and subretinal membranes were collected. Pars plan vitrectomy, 23gauge vitrectomy were done to these cases, then silicone oil removed 6 weeks after primary surgery. Main Outcome Measures: The anatomical success rate,the failure rate ,the rate of retinal breaks in both groups, and reproliferation rate.
    Detailed Description
    50 Patients were included if they had retinal detachment, moderate degrees of PVR, PVR ≥ Grade C, previous buckle surgery and pseudophakia. A good and correct assessment of the detached retina was done. Investigator followed the Lincoff rules to find the retinal breaks. Investigator performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Investigator used Perfluorocarbon liquid (PFCL) for attaching the retina with its gravity. Then performing PFCL against air exchange.The retina will be attached under air tamponade. Laser photocoagulation was performed in the air-filled eye. Investigator applied the laser effects confluently surrounding all retinal breaks. Then silicone oil (1000 centistokes) was injected as a final step and permanent tamponade.After 3-6 months investigator removed the silicone and examined the retina for 6 weeks after surgery to detect the recurrent cases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Detachment
    Keywords
    retina, silicone, laser, break, vitrectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Fifty participants were assigned and divided into two groups. Participants without RD after SO removal was recruited into group A-NRD, and participants with RD after SO removal was recruited into group B-RD.
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Each of the recruited patients were assigned a study number and randomized in accordance with a simple block randomization scheme.
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Non retinal detachment group
    Arm Type
    Sham Comparator
    Arm Description
    35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.
    Arm Title
    retinal detachment group
    Arm Type
    Active Comparator
    Arm Description
    15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.
    Intervention Type
    Procedure
    Intervention Name(s)
    23 PARS PLANA VITRECTOMY
    Other Intervention Name(s)
    SILICONE OIL REMOVAL
    Intervention Description
    We performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Put 23 needle attached to the automated pump for silicone oil extraction. Strict examination of the retina to detect new breaks or untreated breaks. Closure of the sclerotomies.
    Primary Outcome Measure Information:
    Title
    success rate
    Description
    success rate after first RD surgery and silicone oil removal
    Time Frame
    42 days
    Title
    The failure rate
    Description
    The failure rate after silicone oil removal
    Time Frame
    42 days
    Title
    number of surgical interference
    Description
    numbers of vitrectomies done after silicone oil removal
    Time Frame
    4 years
    Secondary Outcome Measure Information:
    Title
    lower retinal breaks
    Description
    The rate of lower retinal breaks in RD group versus the rate of lower retinal breaks in NRD group was
    Time Frame
    4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    58 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: they had retinal detachment, moderate degrees of PVR PVR ≥ Grade C previous buckle surgery pseudophakia. Exclusion Criteria: the retinal tear was greater than 90 degrees presence of intravitreal foreign body previous vitrectomy done before if follow-up data were unavailable for a minimum follow-up of 6 months following the final retinal procedure.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no plan till now

    Learn more about this trial

    23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical

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