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Pneumatic Retinopexy for Severe Bullous Retinal Detachment

Primary Purpose

Retina Detachment

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Scleral Buckling
Drainage-Injection-Pneumoretinopexy
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retina Detachment

Eligibility Criteria

undefined - 60 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Spedali Civili di Brescia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Scleral Buckling

Drainage-Injection-Pneumoretinopexy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Anatomical reattachment of the retina

Secondary Outcome Measures

Refractive error change

Full Information

First Posted
October 23, 2019
Last Updated
October 23, 2019
Sponsor
Università degli Studi di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT04139746
Brief Title
Pneumatic Retinopexy for Severe Bullous Retinal Detachment
Official Title
Pneumatic Retinopexy Preceded by Drainage of Subretinal Fluid for the Treatment of Severe Bullous Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retina Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scleral Buckling
Arm Type
Active Comparator
Arm Description
Scleral Buckling represents the gold standard for retinal detachment in young phakic patients.
Arm Title
Drainage-Injection-Pneumoretinopexy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Scleral Buckling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Drainage-Injection-Pneumoretinopexy
Intervention Description
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 Outcome Measure Information:
Title
Anatomical reattachment of the retina
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Refractive error change
Time Frame
12-month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Spedali Civili di Brescia
City
Brescia
State/Province
BS
ZIP/Postal Code
25100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pneumatic Retinopexy for Severe Bullous Retinal Detachment

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