search
Back to results

Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Primary Purpose

Retinal Detachment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
suprachoroidal buckling
Sponsored by
Fang Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) Clinical diagnosis of rhegmatogenous retinal detachment; (2)myopia < 600 degrees; (3) retinal tear were peripheral part, non-proliferative round hole or horseshoe tear, single or multiple tears within one oclock area; (4) PVR grading: Grade A, B, C1, C2; (5) Subretinal fluid was confined around the tear. (6)phakic.

Exclusion Criteria:

  • (1)Cataract, corneal degeneration, genetic diseases; (2)History of internal eye surgery; (3)The other eye was blind; (4)Postoperative follow-up could not be scheduled; (5)Systemic diseases (asthma, heart failure, myocardial infarction, liver failure, kidney failure and other serious diseases); (6)History of aspirin and other anticoagulant drugs; (7)Severe adverse reactions and systemic diseases occurred during follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    suprachoroidal buckling treatment group

    Arm Description

    suprachoroidal buckling for therapy of rhegmatogenous retinal detachment

    Outcomes

    Primary Outcome Measures

    Retina reattachment
    Number of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography.
    Best Corrected visual Acuity (BCVA)
    Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.
    Intraocular pressure (IOP)
    Patients' IOP assessed by noncontact tonometer
    Treatment-related adverse event
    Number of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage)

    Secondary Outcome Measures

    Retina reattachment
    Number of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography.
    Best Corrected visual Acuity (BCVA)
    Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.
    Intraocular pressure (IOP)
    Patients' IOP assessed by noncontact tonometer
    Treatment-related adverse event
    Number of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage)

    Full Information

    First Posted
    August 13, 2020
    Last Updated
    August 16, 2020
    Sponsor
    Fang Wang
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04518696
    Brief Title
    Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment
    Official Title
    Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    October 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fang Wang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Study of novel surgical technic-suprachoroidal buckling for therapy of rhegmatogenous retinal detachment.It was excpted to reattached the retina and improve visual function of rhegmatogenous retinal detachment patients.
    Detailed Description
    The operation was performed under a surgical microscope with a 25G Chandelier light source and a wide-field observation system to observe the fundus.Location, marking and freezing of the retinal tear on the scleral side . Subretinal fluid is released from the outside of the sclera as needed. The spherical conjunctiva was opened and the radial full-thickness scleral incision (3mm)was made about 8-13mm away from the retinal tear. A "pocket" is formed by injecting some viscoelastic agent into the posterior edge of the sclera and separating the choroid from the sclera using the Healon packaged cannula (No.27 Rycroft cannula). The Healon 5 syringe was connected with a 450-um special tube (a 23 caliber curved tube with olive tip). The cannula is inserted into the supragromal space under microscopic and was scaned by iOCT . Monitor the location of retinal tear during intubation in real time, and adjust the position of the needle: posterior margin of the tear. Once confirmed in accord with the needle position, sodium hyaluronate injection, injection needles to in front of shift to injection, until the tear was completely surrounded in viscoelastic agent to create the choroid crest, usually need 0.2 mL to 0.5 mL. Exit the duct and close the incision with scleral presutures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Detachment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    suprachoroidal buckling treatment group
    Arm Type
    Experimental
    Arm Description
    suprachoroidal buckling for therapy of rhegmatogenous retinal detachment
    Intervention Type
    Procedure
    Intervention Name(s)
    suprachoroidal buckling
    Intervention Description
    Location, marking and freezing of the retinal tear on the scleral side . Subretinal fluid is released from the outside of the sclera as needed. In the quadrant of the retinal tear, the spherical conjunctiva was opened and the radial full-thickness scleral incision (3mm)was made about 8-13mm away from the retinal tear. After the choroid was exposed, a "pocket" is formed by injecting some viscoelastic agent into the posterior edge of the sclera and separating the choroid from the sclera using the Healon packaged cannula (No.27 Rycroft cannula). The Healon 5 syringe was connected with a 450-um special tube . The cannula is inserted into the supragromal space under microscopic and was scaned by iOCT . Once confirmed in accord with the needle position, sodium hyaluronate injection, usually need 0.2 mL to 0.5 mL, application of anterior chamber puncture or subretinal fluid stable intraocular pressure. Exit the duct and close the incision with scleral presutures.
    Primary Outcome Measure Information:
    Title
    Retina reattachment
    Description
    Number of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography.
    Time Frame
    3 months post operation
    Title
    Best Corrected visual Acuity (BCVA)
    Description
    Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.
    Time Frame
    3 months post operation
    Title
    Intraocular pressure (IOP)
    Description
    Patients' IOP assessed by noncontact tonometer
    Time Frame
    3 months post operation
    Title
    Treatment-related adverse event
    Description
    Number of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage)
    Time Frame
    3 months post operation
    Secondary Outcome Measure Information:
    Title
    Retina reattachment
    Description
    Number of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography.
    Time Frame
    12 months post operation
    Title
    Best Corrected visual Acuity (BCVA)
    Description
    Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.
    Time Frame
    12 months post operation
    Title
    Intraocular pressure (IOP)
    Description
    Patients' IOP assessed by noncontact tonometer
    Time Frame
    12 months post operation
    Title
    Treatment-related adverse event
    Description
    Number of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage)
    Time Frame
    12 months post operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) Clinical diagnosis of rhegmatogenous retinal detachment; (2)myopia < 600 degrees; (3) retinal tear were peripheral part, non-proliferative round hole or horseshoe tear, single or multiple tears within one oclock area; (4) PVR grading: Grade A, B, C1, C2; (5) Subretinal fluid was confined around the tear. (6)phakic. Exclusion Criteria: (1)Cataract, corneal degeneration, genetic diseases; (2)History of internal eye surgery; (3)The other eye was blind; (4)Postoperative follow-up could not be scheduled; (5)Systemic diseases (asthma, heart failure, myocardial infarction, liver failure, kidney failure and other serious diseases); (6)History of aspirin and other anticoagulant drugs; (7)Severe adverse reactions and systemic diseases occurred during follow-up.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang Wang, MD,phD
    Phone
    +86-18917683335
    Email
    18917683335@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Conghui Zhang, MD,phD
    Phone
    +86-13671886466
    Email
    linghui0224@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fang Wang, MD,phD
    Organizational Affiliation
    Department of ophthalmology, Shanghai Tenth People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Summarize the experience and deficiency of clinical research process and operation technology, and complete the preliminary report of clinical research.
    IPD Sharing Time Frame
    2021.01.31 The follow-up work of the study subjects was completed, and statistical analysis was conducted 2021.10.31 Continue to complete the follow-up of all patients, and make statistical analysis of all the data, and scientifically evaluate the results; Summarize the experience and deficiency of clinical research process and operation technology, and complete the preliminary report of clinical research.
    IPD Sharing Access Criteria
    All access
    Citations:
    PubMed Identifier
    32318273
    Citation
    Antaki F, Dirani A, Ciongoli MR, Steel DHW, Rezende F. Hemorrhagic complications associated with suprachoroidal buckling. Int J Retina Vitreous. 2020 Apr 16;6:10. doi: 10.1186/s40942-020-00211-6. eCollection 2020.
    Results Reference
    background
    PubMed Identifier
    27429389
    Citation
    Szurman P, Boden K, Januschowski K. Suprachoroidal Hydrogel Buckling as a Surgical Treatment of Retinal Detachment: Biocompatibility and First Experiences. Retina. 2016 Sep;36(9):1786-90. doi: 10.1097/IAE.0000000000001116. No abstract available.
    Results Reference
    result
    PubMed Identifier
    27853956
    Citation
    Mikhail M, El-Rayes EN, Kojima K, Ajlan R, Rezende F. Catheter-guided suprachoroidal buckling of rhegmatogenous retinal detachments secondary to peripheral retinal breaks. Graefes Arch Clin Exp Ophthalmol. 2017 Jan;255(1):17-23. doi: 10.1007/s00417-016-3530-8. Epub 2016 Nov 16.
    Results Reference
    result
    PubMed Identifier
    27482642
    Citation
    El Rayes EN, Mikhail M, El Cheweiky H, Elsawah K, Maia A. SUPRACHOROIDAL BUCKLING FOR THE MANAGEMENT OF RHEGMATOGENOUS RETINAL DETACHMENTS SECONDARY TO PERIPHERAL RETINAL BREAKS. Retina. 2017 Apr;37(4):622-629. doi: 10.1097/IAE.0000000000001214.
    Results Reference
    result
    PubMed Identifier
    28376555
    Citation
    Boden KT, Januschowski K, Szurman P. [Suprachoroidal Hydrogel Buckle - a New Minimal-Invasive Technique in Treatment of Rhegmatogenous Retinal Detachment]. Klin Monbl Augenheilkd. 2019 Mar;236(3):308-312. doi: 10.1055/s-0043-102947. Epub 2017 Apr 4. German.
    Results Reference
    result

    Learn more about this trial

    Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

    We'll reach out to this number within 24 hrs