Pneumatic Retinopexy Preceded by Drainage of Subretinal Fluid for the Treatment of Severe Bullous Retinal Detachment
| Registry | NCT04139746 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 58 (Actual) |
| Sponsor | Università degli Studi di Brescia (Other) |
| Conditions | Retina Detachment |
| Interventions | Scleral Buckling, Drainage-Injection-Pneumoretinopexy (Procedure) |
| Dates | start 2017-03-01, primary completion 2019-03-01, completion 2019-06-30, first posted 2019-10-25, last updated 2019-10-25 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Retina Detachment All trials of Scleral Buckling All trials of Drainage-Injection-Pneumoretinopexy
To compare the efficacy and safety outcomes of scleral buckling (SB) and drainage-injection-pneumoretinopexy (DIP), a modified pneumatic retinopexy technique, in which, before injecting the gas, the drainage of the subretinal fluid is performed with a simultaneous injection of balanced salt solution (BSS) in the vitreous chamber, for the treatment of severe superior bullous rhegmatogenous retinal detachment (SBRD).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Scleral Buckling | Active comparator | Procedure: Scleral Buckling | Scleral Buckling represents the gold standard for retinal detachment in young phakic patients. |
| Drainage-Injection-Pneumoretinopexy | Experimental | Procedure: Drainage-Injection-Pneumoretinopexy | Drainage-Injection-Pneumoretinopexy is a modified pneumatic retinopexy technique, in which, before injecting the gas, the drainage of the subretinal fluid is performed with a simultaneous injection of balanced salt solution (BSS) in the vitreous chamber. |
Sex: All, ages: any to 60 Years
Inclusion Criteria: * provision of written informed consent; * phakic patients aged < 60 years with no or minimal media opacity; * single or multiple retinal breaks (within 1 clock hour) between 8 to 4 o'clock hours; * patients' capability to maintain suggested head positioning for 5 days after the procedure. Exclusion Criteria: * retinal detachment with poor subretinal fluid (absence of severe SBRD); * holes, lattice degeneration or traction within the inferior 4 clock hours; * posterior retinal break, situated behind the equator, not suitable for cryotherapy; * any sign of PVR or severe glaucoma; * myopia above 10 diopters.
| Facility | City | Country | Status |
|---|---|---|---|
| Spedali Civili di Brescia | Brescia, BS | Italy |