Ocular Changes in Vitiligo Patients on Therapy
Chorioretinal Changes in Vitiligo Patients on Therapy
1 other identifier
observational
100
1 country
1
Brief Summary
Vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2022
CompletedFirst Submitted
Initial submission to the registry
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedApril 19, 2022
April 1, 2022
7 months
March 28, 2022
April 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Foveal avascular zone (FAZ) in millimeter (mm).
Immediately after OCT-A for each eye and at one month of follow-up.
Other Outcomes (2)
Changes in visual acuity
Immediately after OCT-A for each eye and at one month of follow-up.
Changes in choroidal thickness
Immediately after OCT-A for each eye and at one month of follow-up.
Study Arms (2)
Vitiligo patients on therapy
Patients diagnosed as vitiligo and on systemic and local therapy.
Control group
Normal subjects recruited from ophthalmology clinic and visit the clinic for regular check-up.
Interventions
Optical coherence tomography angiography scanning will be done for all subjects in the study.
Eligibility Criteria
Dermatology and ophthalmology clinics at banha university.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Benha University
Banhā, QA, 13511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amal A Yousif, MD
Benha University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
March 28, 2022
First Posted
April 19, 2022
Study Start
March 10, 2022
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
April 19, 2022
Record last verified: 2022-04