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Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010110
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
King Khalid University Hospital
Information provided by (Responsible Party):
The Eye Center and The Eye Foundation for Research in Ophthalmology

Brief Summary:
This study assesses the ocular toxicity in patients on high dose hydroxychloroquine (HCQ) as per the latest guidelines of the American Academy of Ophthalmology (AAO).

Condition or disease Intervention/treatment
Hydroxychloroquine Toxic Retinopathy Diagnostic Test: visual field testing (10-2), spectral domain ocular coherence tomography and Fundus auto-fluorescence

Detailed Description:

Hydroxychloroquine (HCQ) is an anti-malarial drug that is used to treat a variety of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus, juvenile idiopathic arthritis and Sjogren's syndrome. Hydroxychloroquine is a less toxic metabolite of chloroquine. There is an ongoing increase in the number of patients who are using HCQ for prolonged duration because of the expanding indications and the relatively safe systemic profile.

Hydroxychloroquine can cause variable ocular adverse effects including corneal deposits, posterior sub-capsular cataract, ciliary body dysfunction and toxic retinopathy. Toxic retinopathy caused by HCQ has been recognized for many years. Patients with toxic retinopathy usually complain of blurry vision. The classical clinical picture of HCQ toxic retinopathy is a bilateral bull's-eye maculopathy, which is caused by a ring of parafoveal RPE depigmentation that spares the fovea. The exact mechanism responsible for the development of this pattern is not fully understood, however, it is believed that the primary damage is in the photoreceptors and outer nuclear layer leading to secondary disruption of the RPE.

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients on hydroxychloroquine
A data collection sheet was used to collect patient's information. All patients underwent a complete ophthalmic examination including assessment of visual acuity, anterior segment examination looking for corneal verticillata and a dilated fundus examination looking for retinal pigment epithelium (RPE) depigmentation either in a para-foveal or extra-macular distribution within the retina. Ancillary tests were done which included: visual field testing (10-2), spectral domain ocular coherence tomography (SDOCT). Fundus auto-fluorescence and mf-ERG were done if further ancillary testing was needed in doubtful cases or to confirm findings.
Diagnostic Test: visual field testing (10-2), spectral domain ocular coherence tomography and Fundus auto-fluorescence
The diagnosis of toxic retinopathy was based on the positivity of at least two objective tests to confirm the subjective findings. The presence or absence of toxicity was recorded.




Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by clinical signs and ancillary tests [ Time Frame: 2 years ]

    A data collection sheet used to collect patient's information regarding the dose per body weight and duration of hydroxychloroquineuse and any risk factors associated with the use of the medication as per the latest AAO guidelines for hydroxychloroquine screening.

    Complete ophthalmic examination including assessment of visual acuity, anterior segment examination looking for corneal verticillata and a dilated fundus examination looking for retinal pigment epithelium (RPE) depigmentation either in a para-foveal or extra-macular distribution within the retina. Ancillary tests including visual field (10-2) testing, spectral domain ocular coherence tomography (SDOCT) fundus auto-fluorescence and multifocal Electroretinogram (ERG).




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients attending the ophthalmology clinics at King Khalid University Hospital and The Eye Center in Riyadh, Saudi Arabia.
Criteria

Inclusion Criteria:

  • Patients on hydroxychloroquine therapy who came for their ophthalmology screening appointment irrespective of the duration of use of the medication.

Exclusion Criteria:

  • Patients who have stopped their hydroxychloroquine medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010110


Locations
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Saudi Arabia
The Eye Center
Riyadh, Saudi Arabia, 11534
Sponsors and Collaborators
The Eye Center and The Eye Foundation for Research in Ophthalmology
King Khalid University Hospital
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Responsible Party: The Eye Center and The Eye Foundation for Research in Ophthalmology
ClinicalTrials.gov Identifier: NCT04010110    
Other Study ID Numbers: TEC 2017-003
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Eye Center and The Eye Foundation for Research in Ophthalmology:
Hydroxychloroquine
Toxic retinopathy
Hydroxychloroquine screening
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases