Retinal Detachment Multiple BreaksDensironNCT05716971
Redetachment Under Densiron for RD Multiple Breaks
An observational study of Retinal Detachment Multiple Breaks, run by Dar El Oyoun Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Retinal Detachment Multiple Breaks
- What is being tested?
- Densiron-68 (heavy silicone oil) tamponade for retinal detachment
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 22 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- - RRD with multiple retinal breaks (MRBs), using Densiron-68 tamponade.
- Age= 16 and older
Who cannot join
- - RRD using conventional silicone oil (SO) or Gas tamponade.
- RRD with single RBs
- Age < 16 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Retinal Redetachment Under Densiron-68 in Rhegmatogenous Retinal Detachment With Multiple Retinal Breaks: A Retrospective Case Control Study
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.
Read the 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.
- Conditions
- Retinal Detachment Multiple Breaks
- Being tested
- Densiron-68 (heavy silicone oil) tamponade for retinal detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densiron-68 (heavy silicone oil) tamponade for retinal detachmentProcedure or surgery
pars plana vitrectomy using Densiron-68 at thee end of surgery
| Study group | Role | What they receive |
|---|---|---|
| RD: (study case group A) | Redetachment under Densiron Receives: Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment | |
| RA : (control group B) | reattachment under Densiron Receives: Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retinal breaks
( 2, 3, 4, or more)
Measured: 1 month
Distribution of retinal breaks
superior and inferior / inferior only
Measured: 1 month
Secondary outcomes (3)
RD Quadrants
(1-4)
Measured: 1 month
PVR
(yes / No)
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Oct 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Detachment Multiple BreaksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar El Oyoun Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Wael Ahmed Ewais, Dar El Oyoun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716971
- Sponsor's protocol ID
- N-123-2022
- Acronym
- Densiron
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Retinal Redetachment Under Densiron-68 in Rhegmatogenous Retinal Detachment With Multiple Retinal Breaks: A Retrospective Case Control Study
- ClinicalTrials.gov ID
- NCT05716971
- Acronym / sponsor ID
- Densiron / N-123-2022
- Conditions
- Retinal Detachment Multiple Breaks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Dar El Oyoun HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RD: (study case group A) | – | Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachmentRedetachment under Densiron |
| RA : (control group B) | – | Procedure: Densiron-68 (heavy silicone oil) tamponade for retinal detachmentreattachment under Densiron |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- - RRD with multiple retinal breaks (MRBs), using Densiron-68 tamponade.
- Age= 16 and older
Key exclusion criteria (3 listed)
- - RRD using conventional silicone oil (SO) or Gas tamponade.
- RRD with single RBs
- Age < 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Densiron-68 (heavy silicone oil) tamponade for retinal detachmentpars plana vitrectomy using Densiron-68 at thee end of surgery | Procedure or surgery | RA : (control group B), RD: (study case group A) |
Primary outcome
Number of retinal breaks
Time frame: 1 month
( 2, 3, 4, or more)
Distribution of retinal breaks
Time frame: 1 month
superior and inferior / inferior only
3 secondary outcomes
RD Quadrants
Time frame: 1 month
PVR
Time frame: 1 month
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment Multiple Breaks, run by Dar El Oyoun Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retinal breaks (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.