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

Retinal Detachment Clinical Trial

— siliconeoil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05817630
• Other study ID #: N-19-2023
• Status: Completed
• Start date: February 15, 2023
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2023
• Source: Dar El Oyoun Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 5, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Other:
• Silicone oil Tamponade for Retinal Detachment
eyes with Rhegmatogenous Retinal Detachment (RRD, for whom pars plana vitrectomy and silicone oil had been performed

Locations

Country	Name	City	State
Egypt	Kasr alainy faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Dar El Oyoun Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	• 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
Primary	• 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	• 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
Secondary	• 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
Secondary	• 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
Secondary	• 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