Redetachment Under Densiron for RD Multiple Breaks

Completed

• Conditions: Retinal Detachment Multiple Breaks
• Interventions: Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment

• Registration Number: NCT05716971
• Lead Sponsor: Dar El Oyoun Hospital

Brief 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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Status Verified: 2023-01
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-01-29
• Last Update Submitted: 2023-01-29
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RD: (study case group A)	Densiron-68 (heavy silicone oil) tamponade for retinal detachment	Redetachment under Densiron
RA : (control group B)	Densiron-68 (heavy silicone oil) tamponade for retinal detachment	reattachment under Densiron

Primary Outcome Measures

Name	Time	Method
Distribution of retinal breaks	1 month	superior and inferior / inferior only
Number of retinal breaks	1 month	( 2, 3, 4, or more)

Secondary Outcome Measures

Name	Time	Method
RD Quadrants	1 month	(1-4)
- Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) Hypotony (IOP < 6 mmHg	1 month	yes / no
PVR	1 month	(yes / No)

Trial Locations

Locations (1)

Kasr alainy faculty of medicine; 🇪🇬 Cairo, Egypt