PArs Plana VitrectomyNCT04774146
Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy
An observational study of PArs Plana Vitrectomy and Retinal Detachment, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial summary
silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PArs Plana Vitrectomy, Retinal Detachment, Silicone Oil Droplets on Intraocular Lens
- What is being tested?
- pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 3 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing previous retinal detachment surgery with pars plana vitrectomy with silicone oil tamponade
Who may be able to join
- previous silicone oil tamponade after pars plana vitrectomy
- age >18 years
- Attached retina
Who cannot join
- unwilling or unable to participate,
- previous multiple eye surgery
- History of Trauma
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Martino
Genova, RM, 16100
Tommaso Rossi, 3482645034, tommaso.rossi024@gmail.com
About this study
silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid
Read the detailed description
silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid.
Therefore consecutive patients scheduled to SiO removal with triple air exchange or vitreous chamber lavage are enrolled and 3 samples of intraocular fluid aspirated during the fluid exchange procedure sent to the lab for SiO emulsion count and quantification.
- Being tested
- pars plana vitrectomy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomyProcedure or surgery
silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange
| Study group | Role | What they receive |
|---|---|---|
| triple air fluid exchange | those undergoing triple air fluid exchange Receives: Procedure: pars plana vitrectomy | |
| irrigation | those undergoing vitreous chamber irrigation with comparable volume of BSS Receives: Procedure: pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of silicone oil emulsification droplets per volume unit
number of silicone oil emulsification droplets per volume unit. Fluid taken from the vitreous chamber during surgery is subsequently analyzed. Therefore time frame is just one: after taking all samples they are analyzed to count oil droplets per volume unit
Measured: 6 months after primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2021
- Study completion3 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PArs Plana VitrectomyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tommaso Rossi, Study director, IRCCS Policlinico San MArtino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774146
- Sponsor's protocol ID
- 1/2000
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2020
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT04774146
- Acronym / sponsor ID
- 1/2000
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 3 Nov 2021 (estimated)
- First posted
- 1 Mar 2021 (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.
silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid
Detailed description
silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid.
Therefore consecutive patients scheduled to SiO removal with triple air exchange or vitreous chamber lavage are enrolled and 3 samples of intraocular fluid aspirated during the fluid exchange procedure sent to the lab for SiO emulsion count and quantification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple air fluid exchange | – | Procedure: pars plana vitrectomythose undergoing triple air fluid exchange |
| irrigation | – | Procedure: pars plana vitrectomythose undergoing vitreous chamber irrigation with comparable volume of BSS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing previous retinal detachment surgery with pars plana vitrectomy with silicone oil tamponade
Key inclusion criteria (3 listed)
- previous silicone oil tamponade after pars plana vitrectomy
- age >18 years
- Attached retina
Key exclusion criteria (3 listed)
- unwilling or unable to participate,
- previous multiple eye surgery
- History of Trauma
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 |
|---|---|---|
| pars plana vitrectomysilicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange | Procedure or surgery | irrigation, triple air fluid exchange |
Primary outcome
number of silicone oil emulsification droplets per volume unit
Time frame: 6 months after primary surgery
number of silicone oil emulsification droplets per volume unit. Fluid taken from the vitreous chamber during surgery is subsequently analyzed. Therefore time frame is just one: after taking all samples they are analyzed to count oil droplets per volume unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Tommaso Rossi study director
IRCCS Policlinico San MArtino
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 PArs Plana Vitrectomy and Retinal Detachment, run by Ospedale Policlinico San Martino at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Oct 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Rossi, MD (+393482645034, tommaso.rossi024@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of silicone oil emulsification droplets per volume unit (time frame: 6 months after primary surgery). 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 27 Oct 2021.