Pneumatic Retinopexy for Severe Bullous Retinal Detachment

Sponsor

Università degli Studi di Brescia (Other)

Overall Status

Completed

CT.gov ID

NCT04139746

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Retina Detachment	Procedure: Scleral Buckling Procedure: Drainage-Injection-Pneumoretinopexy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Scleral Buckling Scleral Buckling represents the gold standard for retinal detachment in young phakic patients.	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.
Experimental: 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.	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: Scleral Buckling

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

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.

Experimental: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Anatomical reattachment of the retina [12-month]

Secondary Outcome Measures

Refractive error change [12-month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spedali Civili di Brescia	Brescia	BS	Italy	25100

Sponsors and Collaborators

Università degli Studi di Brescia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francesco Semeraro, Prof. Francesco Semeraro, Università degli Studi di Brescia

ClinicalTrials.gov Identifier:

NCT04139746

Other Study ID Numbers:

Vitreo004

First Posted:

Oct 25, 2019

Last Update Posted:

Oct 25, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Detachment

Dissociative Disorders

Study Results

No Results Posted as of Oct 25, 2019