Pneumatic Retinopexy for Severe Bullous Retinal Detachment

Not Applicable

Completed

• Conditions: Retina Detachment
• Interventions: Procedure: Drainage-Injection-Pneumoretinopexy; Procedure: Scleral Buckling

• Registration Number: NCT04139746
• Lead Sponsor: Università degli Studi di Brescia

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-23
• Study First Posted: 2019-10-25
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drainage-Injection-Pneumoretinopexy	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.
Scleral Buckling	Scleral Buckling	Scleral Buckling represents the gold standard for retinal detachment in young phakic patients.

Primary Outcome Measures

Name	Time	Method
Anatomical reattachment of the retina	12-month

Secondary Outcome Measures

Name	Time	Method
Refractive error change	12-month

Trial Locations

Locations (1)

Spedali Civili di Brescia; 🇮🇹 Brescia, BS, Italy