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OpenTrials
Completed

NCT Number: NCT05817630

Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment

Our study observes and analyses the influence of the duration of tamponade with silicone oil on the foveal and parafoveal thickness.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr alainy faculty of medicine

Cairo, 12311, Egypt

About this study

Retrospective Cohort study Retrospective review of records of eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed, in the period between January 2019 and December 2021.

After checking inclusion and exclusion criteria; we will enroll all the cases.

We shall observe the duration of silicone oil tamponade, and then divide the cases; accordingly; into 2 groups (Cohort).

  • Group A: 3 months SO Tamponade
  • Group B: 6 months SO Tamponade

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Silicone oil (SO) tamponade ( up to 6 months)
  • Attached retina under SO
  • Attached retina 3 months after Silicone oil Removal (SOR)
  • Normal fellow eye ( no retinal detachment or macular disease)
  • OCT scan performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)

Exclusion criteria

  • • Rhegmatogenous Retinal Detachment (RRD) with other tamponades ( e.g.: Gas, Densiron)
  • SO tamponade less than 3 months, or more than 6 months
  • Recurrent RD under SO
  • Recurrent RD within 3 months after SOR
  • One eyed
  • Vitrectomized fellow eye
  • Retinal detachment, or macular disease in the fellow eye.
  • Posterior staphyloma
  • Anisometropia (history, refraction if possible, spectacles prescription)
  • Absence of any of the OCT scans performed for the operated eyes (before SOR, and 3 months after SOR), and for the fellow eye (at any time during the study)

Treatment and study plan

Silicone oil Tamponade for Retinal Detachment

Other

eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed

Primary outcomes

  1. Change in CFT just before SOR (central foveal thickness)

    Time frame: baseline to time just before silicone oil removal

    Change in CFT just before SOR (from baseline fellow eye) (microns, %) (each group)

  2. Change in PFT just before SOR (Parafoveal thickness)

    Time frame: baseline to time just before silicone oil removal

    Change in PFT just before SOR (from baseline fellow eye) (microns, %) (each group)

  3. • Change in CFT after SOR

    Time frame: from baseline fellow eye to 1 month after silicone oil removal

    • Change in CFT after SOR (from baseline fellow eye) (microns, %) (each group)
  4. • Change in PFT after SOR

    Time frame: from baseline fellow eye to 1 month after silicone oil removal

    • Change in PFT after SOR (from baseline fellow eye) (microns, %) (each group)

Secondary outcomes

  1. • Relative Risk of severe CFT Thinning before SOR (between group A and B)

    Time frame: baseline to time just before silicone oil removal

    • Relative Risk of severe CFT Thinning before SOR (between group A and B)
  2. • Relative Risk of severe PFT Thinning before SOR (between group A and B

    Time frame: baseline to time just before silicone oil removal

    • Relative Risk of severe PFT Thinning before SOR (between group A and B
  3. • Relative Risk of severe CFT Thinning after SOR (between group A and B)

    Time frame: from baseline fellow eye to 1 month after silicone oil removal

    • Relative Risk of severe CFT Thinning after SOR (between group A and B)
  4. • Relative Risk of severe PFT Thinning after SOR (between group A and B)

    Time frame: from baseline fellow eye to 1 month after silicone oil removal

    • Relative Risk of severe PFT Thinning after SOR (between group A and B)

Sponsors and collaborators

Lead sponsor

Dar El Oyoun Hospital

Other

Registry information

Official study title

Impact of Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study

Acronym: siliconeoil

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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