Pneumatic Retinopexy for Severe Bullous Retinal Detachment

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

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).

Study Overview

• Status: Completed
• Conditions: Retina Detachment
• Intervention / Treatment: Procedure: Scleral Buckling; Procedure: Drainage-Injection-Pneumoretinopexy

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BS
    • Brescia, BS, Italy, 25100
      • Spedali Civili di Brescia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anatomical reattachment of the retina	12-month

Secondary Outcome Measures

Outcome Measure	Time Frame
Refractive error change	12-month

Collaborators and Investigators

• Sponsor: Università degli Studi di Brescia

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Retinal Detachment; Dissociative Disorders
• Other Study ID Numbers: Vitreo004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No