MedDataX Logo

Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy

NCT ID: NCT04774146

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-11-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PArs Plana Vitrectomy Retinal Detachment Silicone Oil Droplets on Intraocular Lens

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

triple air fluid exchange

those undergoing triple air fluid exchange

pars plana vitrectomy

Intervention Type PROCEDURE

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

irrigation

those undergoing vitreous chamber irrigation with comparable volume of BSS

pars plana vitrectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pars plana vitrectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ospedale Policlinico San Martino

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tommaso Rossi

Role: STUDY_DIRECTOR

IRCCS Policlinico San MArtino

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS Policlinico San Martino

Genova, RM, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tommaso Rossi, MD

Role: CONTACT

Phone: +393482645034

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tommaso Rossi

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1/2000

Identifier Type: -

Identifier Source: org_study_id