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Completed

NCT Number: NCT04280770

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

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.

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Key information

Age range

23 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

23 PARS PLANA VITRECTOMY

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 21, 2020
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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