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OpenTrials
Completed

NCT Number: NCT04010110

Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics

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).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The Eye Center

Riyadh, 11534, Saudi Arabia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

visual field testing (10-2), spectral domain ocular coherence tomography and Fundus auto-fluorescence

Diagnostic Test

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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

The Eye Center and The Eye Foundation for Research in Ophthalmology

Other

Collaborators

  • King Khalid University Hospital

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2019
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.