Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Study Overview
=================
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.

Official Title
-----------------
Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Conditions
-----------------
Retinal Detachment

Intervention / Treatment
-----------------
* Procedure: suprachoroidal buckling


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: suprachoroidal buckling treatment group<br>suprachoroidal buckling for therapy of rhegmatogenous retinal detachment | Procedure: suprachoroidal buckling<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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） | 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 |