Ocular Changes in Vitiligo Patients on Therapy

• Conditions: Vitiligo; Chorioretinitis; Chorioretinopathy
• Interventions: Diagnostic Test: Optical coherence tomography angiography (OCT-A)

• Registration Number: NCT05335746
• Lead Sponsor: Benha University

Brief Summary

Vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy.

Detailed Description

Chorioretinal changes associated with vitiligo therapy could address patients visual acuity and life style. Early detection of these changes can help these patients to evade such adverse effects.

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2022-03-28
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-17
• Last Update Submitted: 2022-04-17
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• vitiligo patients on systemic and local therapy that regularly visit dermatology clinic at banha university.
• normal subjects seeking regular ophthalmic examination at ophthalmology clinic at banha university.

Exclusion Criteria

• patients with known chronic retinal diseases that may alter OCT-A parameters as age related macular degeneration and diabetic retinopathies.
• patients that refuse to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Optical coherence tomography angiography (OCT-A)	Normal subjects recruited from ophthalmology clinic and visit the clinic for regular check-up.
Vitiligo patients on therapy	Optical coherence tomography angiography (OCT-A)	Patients diagnosed as vitiligo and on systemic and local therapy.

Primary Outcome Measures

Name	Time	Method
Percentage of vessel density (VD) in superficial and deep retinal layer.	Immediately after OCT-A for each eye and at one month of follow-up.	Percentage (%) of superficial and deep vessel density changes in both groups measured by OCT-A software to asses retinal ischemia.

Secondary Outcome Measures

Name	Time	Method
Foveal avascular zone (FAZ) in millimeter (mm).	Immediately after OCT-A for each eye and at one month of follow-up.	Foveal avascular zone measurement in both groups in mm measured by OCT-A software.

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banhā, QA, Egypt