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

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.

Study Overview

• Status: Completed
• Conditions: Retinal Detachment
• Intervention / Treatment: Procedure: 23 PARS PLANA VITRECTOMY

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Non retinal detachment group; 35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.	Procedure: 23 PARS PLANA VITRECTOMY; 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.; Other Names: SILICONE OIL REMOVAL
Active Comparator: retinal detachment group; 15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.	Procedure: 23 PARS PLANA VITRECTOMY; 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.; Other Names: SILICONE OIL REMOVAL

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lower retinal breaks	The rate of lower retinal breaks in RD group versus the rate of lower retinal breaks in NRD group was	4 years

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2009
• Primary Completion (Actual): March 11, 2013
• Study Completion (Actual): March 30, 2013

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: laser; vitrectomy; retina; break; silicone
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment
• Other Study ID Numbers: FWA000017585 FMASU 25/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan till now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No