Redetachment Under Densiron for RD Multiple Breaks

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retinal Detachment Multiple Breaks

Intervention / Treatment
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* Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |