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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04280770

Collaborator

(none)

Enrollment

Arms

49.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment	Procedure: 23 PARS PLANA VITRECTOMY	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Each of the recruited patients were assigned a study number and randomized in accordance with a simple block randomization scheme.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 30, 2009

Actual Primary Completion Date :

Mar 11, 2013

Actual Study Completion Date :

Mar 30, 2013

Arms and Interventions

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

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

Other Names:

SILICONE OIL REMOVAL

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Years to 58 Years

Sexes Eligible for Study:

All

Accepts 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.