Retinal Microvasculature Before and After Silicone Oil by OCTA

Completed

• Conditions: Retinal Vascular

• Registration Number: NCT04928196
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

Detailed Description

Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

The study includes 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Study Timeline

• Study First Submitted: 2021-06-05
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Study Start: 2021-07-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-10-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Exclusion Criteria

• Proliferative diabetic retinopathy, recurrent detachment or macular hole
• Patients with chorioretinal degenerations involving the macula
• Secondary complications as cataract, silicone oil emulsification, or secondary glaucoma
• Media opacity hindering proper imaging

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Macular and optic nerve head vascular density	one year	Using OCTA to assess vascular density changes of the macula and optic nerve head before and after silicone oil removal
Retinal sensitivity by microperimetry	one year	Using microperimetry to assess the retinal sensitivity changes before and after silicone oil removal

Secondary Outcome Measures

Name	Time	Method
Retinal vascular density and best corrected visual acuity	one year	Correlate the change in the retinal vascular density with best corrected visual acuity
Optic nerve head vascular density and best corrected visual acuity	one year	Correlate the change in the optic nerve head vascular density with best corrected visual acuity
Retinal sensitivity and best corrected visual acuity	one year	Correlate the change in the retinal sensitivity with best corrected visual acuity

Trial Locations

Locations (1)

Cairo University teaching hospital; 🇪🇬 Cairo, Egypt