NCT05716971

Redetachment Under Densiron for RD Multiple Breaks

Risk of Retinal Redetachment Under Densiron-68 in Rhegmatogenous Retinal Detachment With Multiple Retinal Breaks: A Retrospective Case Control Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Dar El Oyoun Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Retinal Detachment Multiple Breaks

Interventions

Type	Name	Description
PROCEDURE	Densiron-68 (heavy silicone oil) tamponade for retinal detachment	pars plana vitrectomy using Densiron-68 at thee end of surgery

Timeline

• Start date: 2022-10-01
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: Egypt