Redetachment Under Densiron for RD Multiple Breaks

Dar El Oyoun Hospital

Status: Completed

Conditions: Retinal Detachment Multiple Breaks

Treatments: Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment

Study type: Observational

Funder types: Other

Identifiers

NCT05716971

N-123-2022

Details and patient eligibility

About

Densiron is used as a tamponading agent for inferior retinal detachment with inferior retinal breaks However, data about the use of Densiron -68 for RRD with multiple retinal breaks; especially if involving both superior and inferior quadrants; are not sufficient.

Full description

Inferior retinal detachment (IRD) (retinal detachment with inferior retinal breaks ± proliferative vitreoretinopathy) poses a challenge to primary pars plana vitrectomy because of the insufficient tamponade effect. Lighter than water tamponading agents - including gas and silicone oil (SO)- provide no contact with inferior retina, which may open up inferior retinal breaks and may develop proliferative vitreoretinopathy (PVR) as well.

Heavier than water tamponading agents are used for IRD with a favorable outcome. They include: fluorosilicone oil (FSO) 1 2, perfluorocarbon liquids 3 4 , semifluorinated alkanes namely perfluorhexyloctane (F6H8) 5, and fluorinated alkanes which include: HeavySil 6, Oxane HD 7 8 9 10, HWS 46-3000 11, and Densiron-68. 12-22

Densiron-68 (Fluoron, Neu Ulm, Germany) consists of a mixture of polydimethylsiloxane 5000 (PDMS) (69.5%) and perfluorhexyloctane (H6F8) (30.5%). It has a viscosity of 1387 mPas, specific gravity of 1.06 g/cm3, and interfacial tension of 35 mN/m. it has been successfully employed for IRD with a favorable outcome. 15,17,19,20,22,16,12-14,23,18 The final retinal reattachment rate reached up to 95%. 15 There are several reports about the use of Densiron-68 for IRD associated with PVR which reveal a favorable secondary reattachment rate; ranging between 70% and 95%. 17,21,24,25

However, data about the use of Densiron -68 for RRD with multiple retinal breaks; especially if involving both superior and inferior quadrants; are not sufficient.

Enrollment: 52 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • RRD with multiple retinal breaks (MRBs), using Densiron-68 tamponade.
• Age= 16 and older

Exclusion criteria

• • RRD using conventional silicone oil (SO) or Gas tamponade.
• RRD with single RBs
• Age < 16 years

Trial design

52 participants in 2 patient groups

RD: (study case group A)

Description:

Redetachment under Densiron

Treatment:

Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment

RA : (control group B)

Description:

reattachment under Densiron

Treatment:

Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment