Clinical trial NCT05817630: Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment
Official title: Impact of Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Lead sponsor: Dar El Oyoun Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Change in CFT just before SOR (central foveal thickness)
timeFrame: baseline to time just before silicone oil removal
measure: Change in PFT just before SOR (Parafoveal thickness)
timeFrame: baseline to time just before silicone oil removal
measure: • Change in CFT after SOR
timeFrame: from baseline fellow eye to 1 month after silicone oil removal
measure: • Change in PFT after SOR
timeFrame: from baseline fellow eye to 1 month after silicone oil removal
Secondary outcomes:
measure: • Relative Risk of severe CFT Thinning before SOR (between group A and B)
timeFrame: baseline to time just before silicone oil removal
measure: • Relative Risk of severe PFT Thinning before SOR (between group A and B
timeFrame: baseline to time just before silicone oil removal
measure: • Relative Risk of severe CFT Thinning after SOR (between group A and B)
timeFrame: from baseline fellow eye to 1 month after silicone oil removal
measure: • Relative Risk of severe PFT Thinning after SOR (between group A and B)
timeFrame: from baseline fellow eye to 1 month after silicone oil removal
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy faculty of medicine
Study officials:
References: