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
About this trial
This is an interventional treatment trial for Retinal Detachment
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.
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
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
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Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment
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