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).

Study Overview

• Status: Completed
• Conditions: Hydroxychloroquine Toxic Retinopathy
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11534
    • The Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by clinical signs and ancillary tests	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).	2 years

Collaborators and Investigators

• Sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology
• Collaborators: King Khalid University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Hydroxychloroquine; Toxic retinopathy; Hydroxychloroquine screening
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: TEC 2017-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No