Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy
1 other identifier
observational
20
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2021
CompletedOctober 27, 2021
September 1, 2021
3 months
September 16, 2020
October 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months after primary surgery
Study Arms (2)
triple air fluid exchange
those undergoing triple air fluid exchange
irrigation
those undergoing vitreous chamber irrigation with comparable volume of BSS
Interventions
silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange
Eligibility Criteria
patients undergoing previous retinal detachment surgery with pars plana vitrectomy with silicone oil tamponade
You may qualify if:
- previous silicone oil tamponade after pars plana vitrectomy
- age \>18 years
- Attached retina
You may not qualify if:
- unwilling or unable to participate,
- previous multiple eye surgery
- History of Trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Policlinico San Martino
Genova, RM, 16100, Italy
Biospecimen
lavage fluid (Balanced Salt Solution) irrigating the vitreous chamber
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tommaso Rossi
IRCCS Policlinico San MArtino
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2020
First Posted
March 1, 2021
Study Start
June 1, 2021
Primary Completion
September 1, 2021
Study Completion
November 3, 2021
Last Updated
October 27, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share