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

• Sponsor: Dar El Oyoun Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05817630
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 19.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment	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 Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of Duration of Silicone Oil Tamponade on Foveal and Parafoveal Thickness in Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study
• Actual Study Start Date: Feb 15, 2023
• Actual Primary Completion Date: Apr 1, 2023
• Actual Study Completion Date: Apr 5, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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)

3. • Change in CFT after SOR [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 [from baseline fellow eye to 1 month after silicone oil removal]

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

Secondary Outcome Measures

1. • 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)

2. • 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 PFT Thinning before SOR (between group A and B

3. • 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)

4. • 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr alainy faculty of medicine	Cairo		Egypt	12311

Sponsors and Collaborators

• Dar El Oyoun Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wael Ahmed Ewais, Associate Professor of Ophthalmology Cairo university, Dar El Oyoun Hospital
• ClinicalTrials.gov Identifier: NCT05817630
• Other Study ID Numbers: N-19-2023
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Detachment; Dissociative Disorders

Study Results

No Results Posted as of Apr 18, 2023