Retinal DetachmentNCT04280770
23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical
A study testing 23 PARS PLANA VITRECTOMY in people with Retinal Detachment, run by Ain Shams University.
Trial summary
Objective: to evaluate anatomical and visual outcomes of 23-gauge vitrectomy for retinal detachment with silicone oil injection in fifty cases. The rate of recurrence, the incidence of proliferative vitreoretinopathy (PVR) and the value of risk factors. Read more about this study
- Who is it for?
- Ages 23 to 58 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- 23 PARS PLANA VITRECTOMY
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2009to 30 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 23 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- they had retinal detachment,
- moderate degrees of PVR
- PVR ≥ Grade C
- previous buckle surgery
- pseudophakia.
Who cannot join
- the retinal tear was greater than 90 degrees
- presence of intravitreal foreign body
- previous vitrectomy done before
- if follow-up data were unavailable for a minimum follow-up of 6 months following the final retinal procedure.
About this study
Official title: Surgical Techniques for Epiretinal Membrane Removal in Pars Plana Vitrectomy: A Comparative Study Between 20-Gauge and 23-Gauge Vitrectomy
Objective: to evaluate anatomical and visual outcomes of 23-gauge vitrectomy for retinal detachment with silicone oil injection in fifty cases. The rate of recurrence, the incidence of proliferative vitreoretinopathy (PVR) and the value of risk factors.
Participants and Methods: fifty cases with RD with mixture of epiretinal and subretinal membranes were collected. Pars plan vitrectomy, 23gauge vitrectomy were done to these cases, then silicone oil removed 6 weeks after primary surgery.
Main Outcome Measures: The anatomical success rate,the failure rate ,the rate of retinal breaks in both groups, and reproliferation rate.
Read the detailed description
50 Patients were included if they had retinal detachment, moderate degrees of PVR, PVR ≥ Grade C, previous buckle surgery and pseudophakia. A good and correct assessment of the detached retina was done. Investigator followed the Lincoff rules to find the retinal breaks. Investigator performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Investigator used Perfluorocarbon liquid (PFCL) for attaching the retina with its gravity. Then performing PFCL against air exchange.The retina will be attached under air tamponade. Laser photocoagulation was performed in the air-filled eye.
Investigator applied the laser effects confluently surrounding all retinal breaks. Then silicone oil (1000 centistokes) was injected as a final step and permanent tamponade.After 3-6 months investigator removed the silicone and examined the retina for 6 weeks after surgery to detect the recurrent cases.
- Conditions
- Retinal Detachment
- Being tested
- 23 PARS PLANA VITRECTOMY
- Keywords
- retina, silicone, laser, break, vitrectomy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23 PARS PLANA VITRECTOMYProcedure or surgery
Also called SILICONE OIL REMOVAL
We performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Put 23 needle attached to the automated pump for silicone oil extraction. Strict examination of the retina to detect new breaks or untreated breaks. Closure of the sclerotomies.
| Study group | Role | What they receive |
|---|---|---|
| Non retinal detachment group | Sham comparator | 35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks. Receives: Procedure: 23 PARS PLANA VITRECTOMY |
| retinal detachment group | Active comparator | 15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks. Receives: Procedure: 23 PARS PLANA VITRECTOMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
success rate after first RD surgery and silicone oil removal
Measured: 42 days
The failure rate
The failure rate after silicone oil removal
Measured: 42 days
number of surgical interference
numbers of vitrectomies done after silicone oil removal
Measured: 4 years
Secondary outcomes (1)
lower retinal breaks
The rate of lower retinal breaks in RD group versus the rate of lower retinal breaks in NRD group was
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start30 Jan 2009
- Primary completion11 Mar 2013
- Study completion30 Mar 2013
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Model description
- Fifty participants were assigned and divided into two groups. Participants without RD after SO removal was recruited into group A-NRD, and participants with RD after SO removal was recruited into group B-RD.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled hamdi elbaklish, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280770
- Sponsor's protocol ID
- FWA000017585 FMASU 25/2017
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan till now
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Techniques for Epiretinal Membrane Removal in Pars Plana Vitrectomy: A Comparative Study Between 20-Gauge and 23-Gauge Vitrectomy
- ClinicalTrials.gov ID
- NCT04280770
- Acronym / sponsor ID
- FWA000017585 FMASU 25/2017
- Conditions
- Retinal Detachment
- Keywords
- retina, silicone, laser, break, vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Jan 2009 (actual)
- Primary completion
- 11 Mar 2013 (actual)
- Study completion
- 30 Mar 2013 (actual)
- First posted
- 21 Feb 2020 (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.
Objective: to evaluate anatomical and visual outcomes of 23-gauge vitrectomy for retinal detachment with silicone oil injection in fifty cases. The rate of recurrence, the incidence of proliferative vitreoretinopathy (PVR) and the value of risk factors.
Participants and Methods: fifty cases with RD with mixture of epiretinal and subretinal membranes were collected. Pars plan vitrectomy, 23gauge vitrectomy were done to these cases, then silicone oil removed 6 weeks after primary surgery.
Main Outcome Measures: The anatomical success rate,the failure rate ,the rate of retinal breaks in both groups, and reproliferation rate.
Detailed description
50 Patients were included if they had retinal detachment, moderate degrees of PVR, PVR ≥ Grade C, previous buckle surgery and pseudophakia. A good and correct assessment of the detached retina was done. Investigator followed the Lincoff rules to find the retinal breaks. Investigator performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Investigator used Perfluorocarbon liquid (PFCL) for attaching the retina with its gravity. Then performing PFCL against air exchange.The retina will be attached under air tamponade. Laser photocoagulation was performed in the air-filled eye.
Investigator applied the laser effects confluently surrounding all retinal breaks. Then silicone oil (1000 centistokes) was injected as a final step and permanent tamponade.After 3-6 months investigator removed the silicone and examined the retina for 6 weeks after surgery to detect the recurrent cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Fifty participants were assigned and divided into two groups. Participants without RD after SO removal was recruited into group A-NRD, and participants with RD after SO removal was recruited into group B-RD.
| Arm | Type | Receives |
|---|---|---|
| Non retinal detachment group | Sham comparator | Procedure: 23 PARS PLANA VITRECTOMY35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks. |
| retinal detachment group | Active comparator | Procedure: 23 PARS PLANA VITRECTOMY15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks. |
Who may qualify
- Ages
- 23 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- they had retinal detachment,
- moderate degrees of PVR
- PVR ≥ Grade C
- previous buckle surgery
- pseudophakia.
Key exclusion criteria (4 listed)
- the retinal tear was greater than 90 degrees
- presence of intravitreal foreign body
- previous vitrectomy done before
- if follow-up data were unavailable for a minimum follow-up of 6 months following the final retinal procedure.
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 |
|---|---|---|
| 23 PARS PLANA VITRECTOMYAlso: SILICONE OIL REMOVALWe performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Put 23 needle attached to the automated pump for silicone oil extraction. Strict examination of the retina to detect new breaks or untreated breaks. Closure of the sclerotomies. | Procedure or surgery | Non retinal detachment group, retinal detachment group |
Primary outcome
success rate
Time frame: 42 days
success rate after first RD surgery and silicone oil removal
The failure rate
Time frame: 42 days
The failure rate after silicone oil removal
number of surgical interference
Time frame: 4 years
numbers of vitrectomies done after silicone oil removal
1 secondary outcome
lower retinal breaks
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No. no plan till now
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 23 PARS PLANA VITRECTOMY in people with Retinal Detachment, run by Ain Shams University.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 42 days). The study lists 3 primary outcomes in all. 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 24 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.