Incidence and Risk Factor of Hydroxychloroquine and Chloroquine Retinopathy

NCT ID: NCT02550964

Last Updated: 2015-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-01-31

Brief Summary

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The purpose of this study is to evaluate the incidence and risk factor of toxic maculopathy who treated with hydroxychloroquine or chloroquine due to their autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus. Total 5-year of the study periods, the investigators will screen these patients by baseline examination (Fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography) and observe with same examination for every year.

Detailed Description

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Conditions

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Toxic Maculopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCQ/CQ

Patients who treated with HCQ(Hydroxychloroquine) or CQ(Chloroquine) for autoimmune diseases such as Rheumatoid arthritis(RA), systemic lupus erythematosus(SLE) will be recruited, and get the composite examination for toxic maculopathy.

Composite Examination

Intervention Type PROCEDURE

First, patients will get the baseline ophthalmologic exam and medical evaluation by physicians. As a diagnostic method, the composite examination including fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography will be tested once every year.

Interventions

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Composite Examination

First, patients will get the baseline ophthalmologic exam and medical evaluation by physicians. As a diagnostic method, the composite examination including fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography will be tested once every year.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient who treated with HCQ or CQ due to autoimmune diseases such as RA, SLE
* Patient who did not previously diagnosed with HCQ/CQ toxic retinopathy

Exclusion Criteria

* Aged less than 19 years
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JooYong Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JooYong Lee, Professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JooYong Lee

Role: CONTACT

+82-2-3010-3976

Byung-gil Moon

Role: CONTACT

+82-2-3010-1862

Facility Contacts

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JooYong Lee, Professor

Role: primary

+82-2-3010-3976

Other Identifiers

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2013-0826

Identifier Type: -

Identifier Source: org_study_id

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