Pneumatic Retinopexy for Severe Bullous Retinal Detachment

Università degli Studi di Brescia

Status: Completed

Conditions: Retina Detachment

Treatments: Procedure: Drainage-Injection-Pneumoretinopexy; Procedure: Scleral Buckling

Study type: Interventional

Funder types: Other

Identifiers

NCT04139746

Vitreo004

Details and patient eligibility

About

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).

Enrollment: 58 patients

Sex: All

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Scleral Buckling

Active Comparator group

Description:

Scleral Buckling represents the gold standard for retinal detachment in young phakic patients.

Treatment:

Procedure: Scleral Buckling

Drainage-Injection-Pneumoretinopexy

Experimental group

Description:

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.

Treatment:

Procedure: Drainage-Injection-Pneumoretinopexy