Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2022-10-01
2022-12-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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RD: (study case group A)
Redetachment under Densiron
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
Densiron-68 (heavy silicone oil) tamponade for retinal detachment
pars plana vitrectomy using Densiron-68 at thee end of surgery
Interventions
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Densiron-68 (heavy silicone oil) tamponade for retinal detachment
pars plana vitrectomy using Densiron-68 at thee end of surgery
Eligibility Criteria
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Inclusion Criteria
* Age= 16 and older
Exclusion Criteria
* RRD with single RBs
* Age \< 16 years
16 Years
ALL
No
Sponsors
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Cairo University
OTHER
Dar El Oyoun Hospital
OTHER
Responsible Party
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Wael Ahmed Ewais
Associate Professor of Ophthalmology Cairo university
Locations
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Kasr alainy faculty of medicine
Cairo, , Egypt
Countries
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Other Identifiers
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N-123-2022
Identifier Type: -
Identifier Source: org_study_id
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