NCT05335746

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

March 28, 2022

Last Update Submit

April 17, 2022

Conditions

Keywords

VitiligoChorioretinitis

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.

Diagnostic Test: Optical coherence tomography angiography (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)

Interventions

Optical coherence tomography angiography scanning will be done for all subjects in the study.

Also known as: OCT-A
Control groupVitiligo patients on therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Benha University

Banhā, QA, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

VitiligoChorioretinitis

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesRetinitisRetinal DiseasesEye DiseasesChoroiditisChoroid DiseasesUveal DiseasesUveitis, PosteriorPanuveitisUveitis

Study Officials

  • Amal A Yousif, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

Amal Yousif, MD

CONTACT

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

Locations