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

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

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

Study Overview

• Status: Completed
• Conditions: Retinal Detachment
• Intervention / Treatment: Other: Silicone oil Tamponade for Retinal Detachment

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

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Kasr Alainy Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Group A: 3 months SO Tamponade	Other: Silicone oil Tamponade for Retinal Detachment; eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed
Group B; Group B: 6 months SO Tamponade	Other: Silicone oil Tamponade for Retinal Detachment; eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CFT just before SOR (central foveal thickness)	Change in CFT just before SOR (from baseline fellow eye) (microns, %) (each group)	baseline to time just before silicone oil removal
Change in PFT just before SOR (Parafoveal thickness)	Change in PFT just before SOR (from baseline fellow eye) (microns, %) (each group)	baseline to time just before silicone oil removal
• Change in CFT after SOR	• Change in CFT after SOR (from baseline fellow eye) (microns, %) (each group)	from baseline fellow eye to 1 month after silicone oil removal
• Change in PFT after SOR	• Change in PFT after SOR (from baseline fellow eye) (microns, %) (each group)	from baseline fellow eye to 1 month after silicone oil removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Relative Risk of severe CFT Thinning before 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 PFT Thinning before SOR (between group A and B	• Relative Risk of severe PFT Thinning before SOR (between group A and B	baseline to time just before silicone oil removal
• Relative Risk of severe CFT Thinning after 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 PFT Thinning after 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

Collaborators and Investigators

• Sponsor: Dar El Oyoun Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 5, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Retinal Detachment; Dissociative Disorders
• Other Study ID Numbers: N-19-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No