Pneumatic Retinopexy for Severe Bullous Retinal Detachment

Retina Detachment Clinical Trial

Official title:

Pneumatic Retinopexy Preceded by Drainage of Subretinal Fluid for the Treatment of Severe Bullous Retinal Detachment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139746
• Other study ID #: Vitreo004
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2019
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 30, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dissociative Disorders
• Retina Detachment
• Retinal Detachment

Intervention

Procedure:
• Scleral Buckling
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.
• Drainage-Injection-Pneumoretinopexy
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.

Locations

Country	Name	City	State
Italy	Spedali Civili di Brescia	Brescia	BS

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical reattachment of the retina		12-month
Secondary	Refractive error change		12-month