Clinical trial NCT04280770: 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
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Keywords: retina
silicone
laser
break
vitrectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 23
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: success rate
timeFrame: 42 days
measure: The failure rate
timeFrame: 42 days
measure: number of surgical interference
timeFrame: 4 years
Secondary outcomes:
measure: lower retinal breaks
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
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