23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical
Primary Purpose
Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
23 PARS PLANA VITRECTOMY
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring retina, silicone, laser, break, vitrectomy
Eligibility Criteria
Inclusion Criteria:
- they had retinal detachment,
- moderate degrees of PVR
- PVR ≥ Grade C
- previous buckle surgery
- pseudophakia.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Non retinal detachment group
retinal detachment group
Arm Description
35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.
15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.
Outcomes
Primary Outcome Measures
success rate
success rate after first RD surgery and silicone oil removal
The failure rate
The failure rate after silicone oil removal
number of surgical interference
numbers of vitrectomies done after silicone oil removal
Secondary Outcome Measures
lower retinal breaks
The rate of lower retinal breaks in RD group versus the rate of lower retinal breaks in NRD group was
Full Information
NCT ID
NCT04280770
First Posted
February 19, 2020
Last Updated
February 20, 2020
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04280770
Brief Title
23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical
Official Title
Surgical Techniques for Epiretinal Membrane Removal in Pars Plana Vitrectomy: A Comparative Study Between 20-Gauge and 23-Gauge Vitrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2009 (Actual)
Primary Completion Date
March 11, 2013 (Actual)
Study Completion Date
March 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
retina, silicone, laser, break, vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
Each of the recruited patients were assigned a study number and randomized in accordance with a simple block randomization scheme.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non retinal detachment group
Arm Type
Sham Comparator
Arm Description
35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.
Arm Title
retinal detachment group
Arm Type
Active Comparator
Arm Description
15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.
Intervention Type
Procedure
Intervention Name(s)
23 PARS PLANA VITRECTOMY
Other Intervention Name(s)
SILICONE OIL REMOVAL
Intervention Description
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.
Primary Outcome Measure Information:
Title
success rate
Description
success rate after first RD surgery and silicone oil removal
Time Frame
42 days
Title
The failure rate
Description
The failure rate after silicone oil removal
Time Frame
42 days
Title
number of surgical interference
Description
numbers of vitrectomies done after silicone oil removal
Time Frame
4 years
Secondary Outcome Measure Information:
Title
lower retinal breaks
Description
The rate of lower retinal breaks in RD group versus the rate of lower retinal breaks in NRD group was
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
they had retinal detachment,
moderate degrees of PVR
PVR ≥ Grade C
previous buckle surgery
pseudophakia.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan till now
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23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical
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