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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05847049
Other study ID # N-20-2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 28, 2023
Est. completion date April 6, 2023

Study information

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

Clinical Trial Summary

describing the influence of; combined Eplerenone, intravitreal Aflibercept, and topical Nepafenac; on serous foveal detachment in eyes with CSCR


Description:

Retrospective Review of records of eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period between 2015 and 2021 After checking inclusion and exclusion criteria; we will enroll all cases that have been treated by the combination of eplerenone, intravitreal aflibercept and topical nepafenac. Investigators collected and recorded the following data: - Age - Gender - Systemic hypertension (present or not) - Smoking (Yes / No) - Best corrected visual acuity (BCVA) (baseline, final) - Central macular thickness (CMT) (baseline, final) - Serous detachment Height (SDH) (baseline, final) - Duration of Follow-up ( in months)


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date April 6, 2023
Est. primary completion date March 25, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria: - CSCR eyes treated by combination of Eplerenone, Aflibercept and Nepafenac. Exclusion Criteria: - • CSCR treated by other modalities - CSCR treated by just 1 or 2 components of :Eplerenone, Aflibercept and Nepafenac

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy
Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy

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 central macular thickness (CMT ) in microns reduction in CMT after therapy (baseline, 6 months)
Primary Change in serous detachment height (SDH) in microns reduction in SDH after therapy (baseline, 6 months)
Secondary Change in BCVA number of lines of improvement in BCVA after therapy (baseline, 6 months)
Secondary Duration of Follow-up ( in months) Duration of Follow-up ( in months) (baseline, 6 months)
Secondary Complications (Eplerenone, Aflibercept, and nepafenac) present or absent (baseline, 6 months)
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