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Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy

Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04774146
Enrollment
20
Registered
2021-03-01
Start date
2021-06-01
Completion date
2021-11-03
Last updated
2021-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PArs Plana Vitrectomy, Retinal Detachment, Silicone Oil Droplets on Intraocular Lens

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

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.

Interventions

PROCEDUREpars plana vitrectomy

silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange

Sponsors

Ospedale Policlinico San Martino
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* previous silicone oil tamponade after pars plana vitrectomy * age \>18 years * Attached retina

Exclusion criteria

* unwilling or unable to participate, * previous multiple eye surgery * History of Trauma

Design outcomes

Primary

MeasureTime frameDescription
number of silicone oil emulsification droplets per volume unit6 months after primary surgerynumber 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

Countries

Italy

Contacts

Primary ContactTommaso Rossi, MD
tommaso.rossi024@gmail.com+393482645034

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026