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OpenTrials
Completed

NCT Number: NCT05716971

Redetachment Under Densiron for RD Multiple Breaks

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr alainy faculty of medicine

Cairo, 12311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

pars plana vitrectomy using Densiron-68 at thee end of surgery

Primary outcomes

  1. Number of retinal breaks

    Time frame: 1 month

    ( 2, 3, 4, or more)

  2. Distribution of retinal breaks

    Time frame: 1 month

    superior and inferior / inferior only

Secondary outcomes

  1. RD Quadrants

    Time frame: 1 month

    (1-4)

  2. PVR

    Time frame: 1 month

    (yes / No)

  3. - Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) Hypotony (IOP < 6 mmHg

    Time frame: 1 month

    yes / no

Sponsors and collaborators

Lead sponsor

Dar El Oyoun Hospital

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Acronym: Densiron

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2023
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.