Pneumatic Retinopexy for Severe Bullous Retinal Detachment

NCT04139746 | Completed

• 1 other identifier: Vitreo004
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Retina Detachment

Outcome Measures

Primary Outcomes (1)

• Anatomical reattachment of the retina

  12-month

Secondary Outcomes (1)

• Refractive error change

  12-month

Study Arms (2)

Scleral Buckling

ACTIVE COMPARATOR

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

Procedure: Scleral Buckling

Drainage-Injection-Pneumoretinopexy

EXPERIMENTAL

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.

Procedure: Drainage-Injection-Pneumoretinopexy

Interventions

Scleral Buckling PROCEDURE

Limbal 360 degrees peritomy of the conjunctiva was performed and the four recti muscles were isolated with 4 silk threads 4-0. A width-2 mm silicone encircling band was placed and sutured with 5-0 mersilene on the 4 quadrants of the sclera. Anterior chamber paracentesis was performed, draining about 0.3 mL of aqueous humour, and a buckle (220, 501, 506, or 516; Mira, Waltham, MA, USA) was sutured over the break. In all cases, the drainage puncture was executed at a distance of 11 mm from the limbus, in the area of greatest amount of subretinal fluid. Soon after the drainage puncture, a balanced salt solution (BSS) injection was performed in order to compensate the escape of the subretinal fluid.

Scleral Buckling

Drainage-Injection-Pneumoretinopexy PROCEDURE

According to the location of the sub-retinal fluid, a quadrant-flap of conjunctiva was opened. Indirect ophthalmoscopy evaluation was also used intraoperatively to localize the break and the subretinal fluid drainage site: in this area a vicryl 6-0 thread was passed through the sclera, about 9-10 mm posteriorly from the limbus, to facilitate the surgical maneuvers. The drainage puncture was performed 11 mm posteriorly from the limbus, having attention not to perform it directly above the site of the retinal break. In detail, a 2 mm radial sclera incision was created with a 15° disposable knife. The incision was cautiously deepened down to the choroid, which was finally perforated by a lachrymal dilator having a blunt tip. Soon after beginning the subretinal fluid drainage, an injection of BSS was performed in the opposite quadrant of the sclera (4 mm from the limbus) in order to allow an optimal spillage of the subretinal fluid and to flatten the retina.

Drainage-Injection-Pneumoretinopexy

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

Spedali Civili di Brescia

Brescia, BS, 25100, Italy

Location

MeSH Terms

Conditions

Retinal Detachment

Interventions

Scleral Buckling

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Francesco Semeraro

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 30, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)