- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05335746
Ocular Changes in Vitiligo Patients on Therapy
April 17, 2022 updated by: Ahmed Abdelshafy, Benha University
Chorioretinal Changes in Vitiligo Patients on Therapy
Vitiligo patients on systemic and local therapy may have some ocular adverse effects associated with the disease and its therapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed Abdelshafy, MD
- Phone Number: 01222328766
- Email: ahmad4lg@gmail.com
Study Contact Backup
- Name: Amal Yousif, MD
- Phone Number: 01008128810
- Email: amalderma@gmail.com
Study Locations
-
-
QA
-
Banhā, QA, Egypt, 13511
- Recruiting
- Benha University
-
Contact:
- Ahmed Abdelshafy, MD
- Phone Number: 01222328766
- Email: ahmad4lg@gmail.com
-
Contact:
- Amal Yousif
- Phone Number: 01008128810
- Email: amalderma@gmail.com
-
Sub-Investigator:
- Amal Yousif, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Dermatology and ophthalmology clinics at banha university.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vitiligo patients on therapy
Patients diagnosed as vitiligo and on systemic and local therapy.
|
Optical coherence tomography angiography scanning will be done for all subjects in the study.
Other Names:
|
Control group
Normal subjects recruited from ophthalmology clinic and visit the clinic for regular check-up.
|
Optical coherence tomography angiography scanning will be done for all subjects in the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of vessel density (VD) in superficial and deep retinal layer.
Time Frame: 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.
|
Immediately after OCT-A for each eye and at one month of follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foveal avascular zone (FAZ) in millimeter (mm).
Time Frame: 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.
|
Immediately after OCT-A for each eye and at one month of follow-up.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in visual acuity
Time Frame: Immediately after OCT-A for each eye and at one month of follow-up.
|
Visual acuity measurements in decimal form
|
Immediately after OCT-A for each eye and at one month of follow-up.
|
Changes in choroidal thickness
Time Frame: Immediately after OCT-A for each eye and at one month of follow-up.
|
Choroidal thickness in mm.
|
Immediately after OCT-A for each eye and at one month of follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amal A Yousif, MD, Benha University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2022
Primary Completion (Anticipated)
September 30, 2022
Study Completion (Anticipated)
September 30, 2022
Study Registration Dates
First Submitted
March 28, 2022
First Submitted That Met QC Criteria
April 17, 2022
First Posted (Actual)
April 19, 2022
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 17, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rc 6-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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