Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics

The Eye Center and The Eye Foundation for Research in Ophthalmology

Status: Completed

Conditions: Hydroxychloroquine Toxic Retinopathy

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

Study type: Observational

Funder types: Other

Identifiers

NCT04010110

TEC 2017-003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 63 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

63 participants in 1 patient group

Patients on hydroxychloroquine

Description:

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.

Treatment:

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