Clinical trial NCT05716971: Redetachment Under Densiron for RD Multiple Breaks
Official title: Risk of Retinal Redetachment Under Densiron-68 in Rhegmatogenous Retinal Detachment With Multiple Retinal Breaks: A Retrospective Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment Multiple Breaks
Lead sponsor: Dar El Oyoun Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2023-02-08
Enrollment: 52
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of retinal breaks
timeFrame: 1 month
measure: Distribution of retinal breaks
timeFrame: 1 month
Secondary outcomes:
measure: RD Quadrants
timeFrame: 1 month
measure: PVR
timeFrame: 1 month
measure: - Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) - Hypotony (IOP < 6 mmHg) (yes/ no) Hypotony (IOP < 6 mmHg
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy faculty of medicine
Study officials:
References: