Spring Loaded Syringe for Active Silicon Oil Extraction

January 14, 2026 updated by: Alaa Abdalsadek Ahmed Sinjab, Sohag University

Vitrectomy Machine Versus Spring Loaded Syringe for Active Silicon Oil Extraxtion

The aim of our study is to compare between two techniques used for active SOR. The outcomes include efficiency and safety.

Patients with silicon filled eyes and prepared for SOR 540 eyes of 505 patients (one eye in 470 patients, and both eyes in 35 patients) were enrolled in the study.

All eyes underwent SOR using 23-Gauge PPV. The eyes were classified according to the surgical technique used for SOR into two groups:- Group A: SOR was performed using SO extraction program built in Optikon vitrectomy device Group B: SOR was performed using modified spring loaded syringe.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt, 82511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients subjected previously to pars plana vitrectomy with silicon oil tamponade.

Exclusion Criteria:

  • Recurrent retinal detachment
  • Previous scleral buckling
  • Previous glaucoma surgery
  • Bleeding tendencies
  • Anterior staphyloma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Conventional technique using vitrectomy machine
Device: Vitrectomy machine
Active silicon oil extraction through 23G pars plana system vitrectomy machine
Active Comparator: Group B
Spring loaded syringe for silicon oil extraction
Device: Spring loaded syringe
5 mml syringe with spring in its plunger and rubber connection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: During the surgical procedure and up to 3 months postoperative
Incidence of operative and postoperative complications in both groups
During the surgical procedure and up to 3 months postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required for silicon oil extraction
Time Frame: From beginning of silicon oil extraction until complete extraction, It is recorded for every individual surgical procedure
Total time in seconds needed to completely remove silicon oil, it is recorded by an assistant.
From beginning of silicon oil extraction until complete extraction, It is recorded for every individual surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-25-11-9PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All unidentified IPD will be available and can be shared with other researchers.

IPD Sharing Time Frame

Within one year, and will be available for unlimited time.

IPD Sharing Access Criteria

All researchers will be able to access IPD through trial registry website or via r quest through our individual emails.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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