Ocular Changes in Vitiligo Patients on Therapy

Vitiligo Clinical Trial

Official title:

Chorioretinal Changes in Vitiligo Patients on Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335746
• Other study ID #: Rc 6-2022
• Status: Recruiting
• Start date: March 10, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2022
• Source: Benha University
• Contact: Ahmed Abdelshafy, MD
• Phone: 01222328766
• Email: ahmad4lg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chorioretinitis
• Chorioretinopathy
• Vitiligo

Intervention

Diagnostic Test:
• Optical coherence tomography angiography (OCT-A)
Optical coherence tomography angiography scanning will be done for all subjects in the study.

Locations

Country	Name	City	State
Egypt	Benha University	Banha	QA

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in visual acuity	Visual acuity measurements in decimal form	Immediately after OCT-A for each eye and at one month of follow-up.
Other	Changes in choroidal thickness	Choroidal thickness in mm.	Immediately after OCT-A for each eye and at one month of follow-up.
Primary	Percentage of vessel density (VD) in superficial and deep retinal layer.	Percentage (%) of superficial and deep vessel density changes in both groups measured by OCT-A software to asses retinal ischemia.	Immediately after OCT-A for each eye and at one month of follow-up.
Secondary	Foveal avascular zone (FAZ) in millimeter (mm).	Foveal avascular zone measurement in both groups in mm measured by OCT-A software.	Immediately after OCT-A for each eye and at one month of follow-up.