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NCT04928196 Clinical Trial

Retinal Microvasculature Before and After Silicone Oil by OCTA

Retinal Vascular Clinical Trial

Official title:
Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04928196
Other study ID # 6-1-2021-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 12, 2021
Est. completion date October 15, 2022

Study information
Verified date March 2023
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 15, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Microperimtery and optical coherence tomography angiography OCTA
observational: Investigations are done to assess the retinal microvasculature and function before and after silicone oil removal

Locations
Country Name City State
Egypt Cairo University teaching hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Macular and optic nerve head vascular density Using OCTA to assess vascular density changes of the macula and optic nerve head before and after silicone oil removal one year
Primary Retinal sensitivity by microperimetry Using microperimetry to assess the retinal sensitivity changes before and after silicone oil removal one year
Secondary Retinal vascular density and best corrected visual acuity Correlate the change in the retinal vascular density with best corrected visual acuity one year
Secondary Optic nerve head vascular density and best corrected visual acuity Correlate the change in the optic nerve head vascular density with best corrected visual acuity one year
Secondary Retinal sensitivity and best corrected visual acuity Correlate the change in the retinal sensitivity with best corrected visual acuity one year
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