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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280770
Recruitment Status : Completed
First Posted : February 21, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
khaled hamdi elbaklish, 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.


Condition or disease Intervention/treatment Phase
Retinal Detachment Procedure: 23 PARS PLANA VITRECTOMY Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : January 30, 2009
Actual Primary Completion Date : March 11, 2013
Actual Study Completion Date : March 30, 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: SILICONE OIL REMOVAL




Primary Outcome Measures :
  1. success rate [ Time Frame: 42 days ]
    success rate after first RD surgery and silicone oil removal

  2. The failure rate [ Time Frame: 42 days ]
    The failure rate after silicone oil removal

  3. number of surgical interference [ Time Frame: 4 years ]
    numbers of vitrectomies done after silicone oil removal


Secondary Outcome Measures :
  1. lower retinal breaks [ Time Frame: 4 years ]
    The rate of lower retinal breaks in RD group versus the rate of lower retinal breaks in NRD group was



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: khaled hamdi elbaklish, Clinical Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04280770    
Other Study ID Numbers: FWA000017585 FMASU 25/2017
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan till now

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by khaled hamdi elbaklish, Ain Shams University:
retina
silicone
laser
break
vitrectomy
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Diseases
Eye Diseases