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NCT04774146 Clinical Trial

Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy

Retinal Detachment Clinical Trial

Official title:
Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04774146
Other study ID # 1/2000
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date November 3, 2021

Study information
Verified date September 2021
Source Ospedale Policlinico San Martino
Contact Tommaso Rossi, MD
Phone +393482645034
Email tommaso.rossi024@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date November 3, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• pars plana vitrectomy
silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange

Locations
Country Name City State
Italy IRCCS Policlinico San Martino Genova RM

Sponsors (1)
Lead Sponsor Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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