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

Study Contact Backup

Study Locations

  • Egypt
    • QA
      • Banhā, QA, Egypt, 13511
        • Recruiting
        • Benha University
        • Contact:
        • Contact:
        • 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.
Diagnostic test: Optical coherence tomography angiography (OCT-A)
Optical coherence tomography angiography scanning will be done for all subjects in the study.
Other Names:
  • OCT-A
Control group
Normal subjects recruited from ophthalmology clinic and visit the clinic for regular check-up.
Diagnostic test: Optical coherence tomography angiography (OCT-A)
Optical coherence tomography angiography scanning will be done for all subjects in the study.
Other Names:
  • OCT-A

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

Benha University

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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