Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Retinal Detachment Clinical Trial

Official title:

Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04518696
• Other study ID #: 08.01.10002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: Shanghai 10th People's Hospital
• Contact: Fang Wang, MD,phD
• Phone: +86-18917683335
• Email: 18917683335[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Procedure:
• suprachoroidal buckling
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fang Wang

References & Publications (5)

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

Outcome

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