Redetachment Under Densiron for RD Multiple Breaks (Densiron)

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

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.

Study Overview

• Status: Completed
• Conditions: Retinal Detachment Multiple Breaks
• Intervention / Treatment: Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment

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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Kasr Alainy Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective review of records of cases of "Rhegmatogenous Retinal Detachment (RRD)with multiple Retinal breaks (MRBs) ", for whom pars plana vitrectomy using Densiron-68 as a tamponading agent had been performed, in the period from March 2014 till November 2019

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RD: (study case group A); Redetachment under Densiron	Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment; pars plana vitrectomy using Densiron-68 at thee end of surgery
RA : (control group B); reattachment under Densiron	Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment; pars plana vitrectomy using Densiron-68 at thee end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of retinal breaks	( 2, 3, 4, or more)	1 month
Distribution of retinal breaks	superior and inferior / inferior only	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RD Quadrants	(1-4)	1 month
PVR	(yes / No)	1 month
- Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) Hypotony (IOP < 6 mmHg	yes / no	1 month

Collaborators and Investigators

• Sponsor: Dar El Oyoun Hospital
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2022
• Primary Completion (ACTUAL): December 22, 2022
• Study Completion (ACTUAL): December 22, 2022

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 29, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment
• Other Study ID Numbers: N-123-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No