Redetachment Under Densiron for RD Multiple Breaks

• Sponsor: Dar El Oyoun Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05716971
• Collaborator: Cairo University (Other)
• Enrollment: 52
• Location: 1
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 19.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment Multiple Breaks	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 Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Risk of Retinal Redetachment Under Densiron-68 in Rhegmatogenous Retinal Detachment With Multiple Retinal Breaks: A Retrospective Case Control Study
• Actual Study Start Date: Oct 1, 2022
• Actual Primary Completion Date: Dec 22, 2022
• Actual Study Completion Date: Dec 22, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Number of retinal breaks [1 month]

   ( 2, 3, 4, or more)

2. Distribution of retinal breaks [1 month]

   superior and inferior / inferior only

Secondary Outcome Measures

1. RD Quadrants [1 month]

   (1-4)

2. PVR [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 [1 month]

   yes / no

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr alainy faculty of medicine	Cairo		Egypt	12311

Sponsors and Collaborators

• Dar El Oyoun Hospital
• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wael Ahmed Ewais, Associate Professor of Ophthalmology Cairo university, Dar El Oyoun Hospital
• ClinicalTrials.gov Identifier: NCT05716971
• Other Study ID Numbers: N-123-2022
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Detachment

Study Results

No Results Posted as of Feb 8, 2023