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

Not Applicable

Completed

• Conditions: Retinal Detachment
• Interventions: Procedure: 23 PARS PLANA VITRECTOMY

• Registration Number: NCT04280770
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2009-01-30
• Primary Completion: 2013-03-11
• Study Completion: 2013-03-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-20
• Last Update Submitted: 2020-02-20
• Study First Posted: 2020-02-21
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• they had retinal detachment,
• moderate degrees of PVR
• PVR ≥ Grade C
• previous buckle surgery
• pseudophakia.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
retinal detachment group	23 PARS PLANA VITRECTOMY	15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.
Non retinal detachment group	23 PARS PLANA VITRECTOMY	35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.

Primary Outcome Measures

Name	Time	Method
success rate	42 days	success rate after first RD surgery and silicone oil removal
number of surgical interference	4 years	numbers of vitrectomies done after silicone oil removal
The failure rate	42 days	The failure rate after silicone oil removal

Secondary Outcome Measures

Name	Time	Method
lower retinal breaks	4 years	The rate of lower retinal breaks in RD group versus the rate of lower retinal breaks in NRD group was