23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical

Ain Shams University

Status: Completed

Conditions: Retinal Detachment

Treatments: Procedure: 23 PARS PLANA VITRECTOMY

Study type: Interventional

Funder types: Other

Identifiers

NCT04280770

FWA000017585 FMASU 25/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 23 to 58 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Non retinal detachment group

Sham Comparator group

Description:

35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.

Treatment:

Procedure: 23 PARS PLANA VITRECTOMY

retinal detachment group

Active Comparator group

Description:

15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.

Treatment:

Procedure: 23 PARS PLANA VITRECTOMY