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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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