Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Not Applicable

• Conditions: Retinal Detachment
• Interventions: Procedure: suprachoroidal buckling

• Registration Number: NCT04518696
• Lead Sponsor: Fang Wang

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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-16
• Last Update Submitted: 2020-08-16
• Study First Posted: 2020-08-19
• Last Update Posted: 2020-08-19
• Study Start: 2020-09-01
• Primary Completion: 2020-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
suprachoroidal buckling treatment group	suprachoroidal buckling	suprachoroidal buckling for therapy of rhegmatogenous retinal detachment

Primary Outcome Measures

Name	Time	Method
Treatment-related adverse event	3 months post operation	Number of participants with treatment-related adverse events（including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage）
Retina reattachment	3 months post operation	Number of participants who achieved retina reattachment assessed by fundus photography，b-scan ultrasonography and optical coherence tomography.
Best Corrected visual Acuity (BCVA）	3 months post operation	Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.
Intraocular pressure (IOP)	3 months post operation	Patients' IOP assessed by noncontact tonometer

Secondary Outcome Measures

Name	Time	Method
Best Corrected visual Acuity (BCVA）	12 months post operation	Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.
Intraocular pressure (IOP)	12 months post operation	Patients' IOP assessed by noncontact tonometer
Retina reattachment	12 months post operation	Number of participants who achieved retina reattachment assessed by fundus photography，b-scan ultrasonography and optical coherence tomography.
Treatment-related adverse event	12 months post operation	Number of participants with treatment-related adverse events（including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage）