Retinal Detachment Clinical Trial
Official title:
Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment
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.
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fang Wang |
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. — View 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. Germa — View 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. — View 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/s00417-016-35 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retina reattachment | Number of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography. | 3 months post operation | |
Primary | Best Corrected visual Acuity (BCVA) | Patients' best corrected visual acuity assessed by logarithmic visual acuity charts. | 3 months post operation | |
Primary | Intraocular pressure (IOP) | Patients' IOP assessed by noncontact tonometer | 3 months post operation | |
Primary | Treatment-related adverse event | Number of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage) | 3 months post operation | |
Secondary | Retina reattachment | Number of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography. | 12 months post operation | |
Secondary | Best Corrected visual Acuity (BCVA) | Patients' best corrected visual acuity assessed by logarithmic visual acuity charts. | 12 months post operation | |
Secondary | Intraocular pressure (IOP) | Patients' IOP assessed by noncontact tonometer | 12 months post operation | |
Secondary | Treatment-related adverse event | Number of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage) | 12 months post operation |
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