Health TrialsbyHealthPanel

Spring Loaded Syringe for Active Silicon Oil Extraction

ConditionRetinal Detachment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSohag University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Recurrent retinal detachment

Previous scleral buckling

Previous glaucoma surgery

Bleeding tendencies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitrectomy machine

    Device

    Active silicon oil extraction through 23G pars plana system vitrectomy machine

  • Spring loaded syringe

    Device

    5 mml syringe with spring in its plunger and rubber connection

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of complications

Incidence of operative and postoperative complications in both groups

Time frame
During the surgical procedure and up to 3 months postoperative

Secondary outcomes

Other outcomes

1

Time required for silicon oil extraction

Total time in seconds needed to completely remove silicon oil, it is recorded by an assistant.

Time frame
From beginning of silicon oil extraction until complete extraction, It is recorded for every individual surgical procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov
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