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

Completed
Conditions
Retinal Detachment
Interventions
Other: Silicone oil Tamponade for Retinal Detachment
Registration Number
NCT05817630
Lead Sponsor
Dar El Oyoun Hospital
Brief Summary

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

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Group ASilicone oil Tamponade for Retinal DetachmentGroup A: 3 months SO Tamponade
Group BSilicone oil Tamponade for Retinal DetachmentGroup B: 6 months SO Tamponade
Primary Outcome Measures
NameTimeMethod
• Change in PFT after SORfrom baseline fellow eye to 1 month after silicone oil removal

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

• Change in CFT after SORfrom baseline fellow eye to 1 month after silicone oil removal

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

Change in CFT just before SOR (central foveal thickness)baseline to time just before silicone oil removal

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

Change in PFT just before SOR (Parafoveal thickness)baseline to time just before silicone oil removal

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

Secondary Outcome Measures
NameTimeMethod
• Relative Risk of severe PFT Thinning before SOR (between group A and Bbaseline to time just before silicone oil removal

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

• Relative Risk of severe CFT Thinning after SOR (between group A and B)from baseline fellow eye to 1 month after silicone oil removal

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

• Relative Risk of severe CFT Thinning before SOR (between group A and B)baseline to time just before silicone oil removal

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

• Relative Risk of severe PFT Thinning after SOR (between group A and B)from baseline fellow eye to 1 month after silicone oil removal

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

Trial Locations

Locations (1)

Kasr alainy faculty of medicine

🇪🇬

Cairo, Egypt

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