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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suprachoroidal buckling treatment group | Experimental | suprachoroidal buckling for therapy of rhegmatogenous retinal detachment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suprachoroidal buckling | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retina reattachment | Number of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography. | 3 months post operation |
| Best Corrected visual Acuity (BCVA) | Patients' best corrected visual acuity assessed by logarithmic visual acuity charts. | 3 months post operation |
| Intraocular pressure (IOP) | Patients' IOP assessed by noncontact tonometer | 3 months post operation |
| Treatment-related adverse event | Number of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage) | 3 months post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Retina reattachment | Number of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography. | 12 months post operation |
| Best Corrected visual Acuity (BCVA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Wang, MD,phD | Contact | +86-18917683335 | 18917683335@163.com | |
| Conghui Zhang, MD,phD | Contact | +86-13671886466 | linghui0224@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Wang, MD,phD | Department of ophthalmology, Shanghai Tenth People's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32318273 | Background | 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. | |
| 27429389 | Result | 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. |
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Summarize the experience and deficiency of clinical research process and operation technology, and complete the preliminary report of clinical research.
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.
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.
| 12 months post operation |
| Intraocular pressure (IOP) | Patients' IOP assessed by noncontact tonometer | 12 months post operation |
| Treatment-related adverse event | Number of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage) | 12 months post operation |
| 27853956 | Result | 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. |
| 27482642 | Result | 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. |
| 28376555 | Result | 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. |