Retinal DetachmentNCT07363889
Spring Loaded Syringe for Active Silicon Oil Extraction
A study testing Vitrectomy machine and Spring loaded syringe in people with Retinal Detachment, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Vitrectomy machine and Spring loaded syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2022to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients subjected previously to pars plana vitrectomy with silicon oil tamponade.
Who cannot join
- Recurrent retinal detachment
- Previous scleral buckling
- Previous glaucoma surgery
- Bleeding tendencies
- Anterior staphyloma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alaa A A Sinjab, Doctor degree in Ophthalmology contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medicine
Sohag, Sohag Governorate, 82511
Alaa A A Sinjab, MD, +20-01064037382, alaa.abdelsadek@med.sohag.edu.eg
About this study
Official title: 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.
- Conditions
- Retinal Detachment
- Being tested
- Vitrectomy machine, Spring loaded syringe
- Keywords
- Pars plana vitrectomy, Silicon oil tamponade, Silicon oil extraction
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy machineDevice
Active silicon oil extraction through 23G pars plana system vitrectomy machine
Spring loaded syringeDevice
5 mml syringe with spring in its plunger and rubber connection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Conventional technique using vitrectomy machine Receives: Device: Vitrectomy machine |
| Group B | Active comparator | Spring loaded syringe for silicon oil extraction Receives: Device: Spring loaded syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
Incidence of operative and postoperative complications in both groups
Measured: During the surgical procedure and up to 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start4 Jan 2022
- Primary completion30 Dec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdalsadek Ahmed Sinjab, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363889
- Sponsor's protocol ID
- Soh-Med-25-11-9PD
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All unidentified IPD will be available and can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitrectomy Machine Versus Spring Loaded Syringe for Active Silicon Oil Extraxtion
- ClinicalTrials.gov ID
- NCT07363889
- Acronym / sponsor ID
- Soh-Med-25-11-9PD
- Conditions
- Retinal Detachment
- Keywords
- Pars plana vitrectomy, Silicon oil tamponade, Silicon oil extraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Vitrectomy machineConventional technique using vitrectomy machine |
| Group B | Active comparator | Device: Spring loaded syringeSpring loaded syringe for silicon oil extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients subjected previously to pars plana vitrectomy with silicon oil tamponade.
Key exclusion criteria (5 listed)
- Recurrent retinal detachment
- Previous scleral buckling
- Previous glaucoma surgery
- Bleeding tendencies
- Anterior staphyloma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitrectomy machineActive silicon oil extraction through 23G pars plana system vitrectomy machine | Device | Group A |
| Spring loaded syringe5 mml syringe with spring in its plunger and rubber connection | Device | Group B |
Primary outcome
Incidence of complications
Time frame: During the surgical procedure and up to 3 months postoperative
Incidence of operative and postoperative complications in both groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. All unidentified IPD will be available and can be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa A A Sinjab, Doctor degree in Ophthalmology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy machine and Spring loaded syringe in people with Retinal Detachment, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa A A Sinjab, Doctor degree in Ophthalmology (+20-01064037382, alaa.abdelsadek@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications (time frame: During the surgical procedure and up to 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.