Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy

• Conditions: Retinal Detachment; Silicone Oil Droplets on Intraocular Lens; PArs Plana Vitrectomy
• Interventions: Procedure: pars plana vitrectomy

• Registration Number: NCT04774146
• Lead Sponsor: Ospedale Policlinico San Martino

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.

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Study Start: 2021-06-01
• Status Verified: 2021-09
• Primary Completion: 2021-09-01
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27
• Study Completion: 2021-11-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
triple air fluid exchange	pars plana vitrectomy	those undergoing triple air fluid exchange
irrigation	pars plana vitrectomy	those undergoing vitreous chamber irrigation with comparable volume of BSS

Primary Outcome Measures

Name	Time	Method
number of silicone oil emulsification droplets per volume unit	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

Trial Locations

Locations (1)

IRCCS Policlinico San Martino; 🇮🇹 Genova, RM, Italy