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

Retinal Detachment Clinical Trial

Official title:

Surgical Techniques for Epiretinal Membrane Removal in Pars Plana Vitrectomy: A Comparative Study Between 20-Gauge and 23-Gauge Vitrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280770
• Other study ID #: FWA000017585 FMASU 25/2017
• Status: Completed
• Phase: N/A
• Start date: January 30, 2009
• Est. completion date: March 30, 2013

Study information

• Verified date: February 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 30, 2013
• Est. primary completion date: March 11, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 58 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate	success rate after first RD surgery and silicone oil removal	42 days
Primary	The failure rate	The failure rate after silicone oil removal	42 days
Primary	number of surgical interference	numbers of vitrectomies done after silicone oil removal	4 years
Secondary	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