NCT07363889

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jan 2022May 2027

Study Start

First participant enrolled

January 4, 2022

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

December 19, 2025

Last Update Submit

January 14, 2026

Conditions

Retinal Detachment

Keywords

Pars plana vitrectomySilicon oil tamponadeSilicon oil extraction

Outcome Measures

Primary Outcomes (1)

  • Incidence of complications

    Incidence of operative and postoperative complications in both groups

    During the surgical procedure and up to 3 months postoperative

Other Outcomes (1)

  • Time required for silicon oil extraction

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

Study Arms (2)

Group A

ACTIVE COMPARATOR

Conventional technique using vitrectomy machine

Device: Vitrectomy machine

Group B

ACTIVE COMPARATOR

Spring loaded syringe for silicon oil extraction

Device: Spring loaded syringe

Interventions

Vitrectomy machineDEVICE

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

Group A
Spring loaded syringeDEVICE

5 mml syringe with spring in its plunger and rubber connection

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Sohag Governorate, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Central Study Contacts

Alaa A A Sinjab, Doctor degree in Ophthalmology

CONTACT

+20-01064037382alaa.abdelsadek@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 23, 2026

Study Start

January 4, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Within one year, and will be available for unlimited time.
Access Criteria
All researchers will be able to access IPD through trial registry website or via r quest through our individual emails.

Locations

EG(1)