Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07363889

Vitrectomy Machine Versus Spring Loaded Syringe for Active Silicon Oil Extraction

Led by Sohag University · Updated on 2026-01-23

200

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two techniques used for active silicon oil removal (SOR) in patients who have silicon-filled eyes and are prepared for SOR. The study aims to evaluate the efficiency and safety of these methods during and after surgery. This trial involves 540 eyes from 505 patients, including some with both eyes treated. All participants undergo SOR using a 23-Gauge pars plana vitrectomy (PPV). The eyes are divided into two groups based on the surgical technique used: Group A uses a vitrectomy machine with a specific SO extraction program, while Group B uses a modified spring loaded syringe. Both techniques are actively compared to assess their outcomes. Participants will be monitored for complications during the surgical procedure and up to three months afterward. The study includes randomized allocation and double masking to ensure unbiased results. Researchers will evaluate safety and effectiveness through these follow-up assessments, with the total participation time covering the surgery and postoperative period.

CONDITIONS

Brief Title

Spring Loaded Syringe for Active Silicon Oil Extraction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients previously treated with pars plana vitrectomy using silicon oil tamponade
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate post-operative period

Participants undergo silicon oil extraction using either a vitrectomy machine or a spring loaded syringe.

1 surgery visit and immediate post-operative care

Post-operative Follow-up

Duration - Up to 3 months post-operative

Participants are monitored for complications during the surgical procedure and up to 3 months post-operative.

Approximately 6 post-operative visits

Trial Site Locations

Total: 1 location

1

Sohag Faculty of Medicine

Sohag, Sohag Governorate, Egypt, 82511

Actively Recruiting

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Research Team

A

Alaa A A Sinjab, Doctor degree in Ophthalmology

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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