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Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04518696
Enrollment
15
Registered
2020-08-19
Start date
2020-09-01
Completion date
2022-12-31
Last updated
2020-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

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.

Interventions

PROCEDUREsuprachoroidal 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.

Sponsors

Fang Wang
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Treatment-related adverse event3 months post operationNumber of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage)
Retina reattachment3 months post operationNumber 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 operationPatients' best corrected visual acuity assessed by logarithmic visual acuity charts.
Intraocular pressure (IOP)3 months post operationPatients' IOP assessed by noncontact tonometer

Secondary

MeasureTime frameDescription
Retina reattachment12 months post operationNumber of participants who achieved retina reattachment assessed by fundus photography,b-scan ultrasonography and optical coherence tomography.
Best Corrected visual Acuity (BCVA)12 months post operationPatients' best corrected visual acuity assessed by logarithmic visual acuity charts.
Intraocular pressure (IOP)12 months post operationPatients' IOP assessed by noncontact tonometer
Treatment-related adverse event12 months post operationNumber of participants with treatment-related adverse events(including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage)

Contacts

Primary ContactFang Wang, MD,phD
18917683335@163.com+86-18917683335
Backup ContactConghui Zhang, MD,phD
linghui0224@126.com+86-13671886466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026