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OpenTrials
Completed

NCT Number: NCT04139746

Pneumatic Retinopexy for 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).

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Key information

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spedali Civili di Brescia

Brescia, BS, 25100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Anatomical reattachment of the retina

    Time frame: 12-month

Secondary outcomes

  1. Refractive error change

    Time frame: 12-month

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2019
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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