Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics

NCT04010110 | Completed DMC

• 1 other identifier: TEC 2017-003
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Hydroxychloroquine Toxic Retinopathy

Keywords

Hydroxychloroquine; Toxic retinopathy; Hydroxychloroquine screening

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

Patients on hydroxychloroquine

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who have stopped their hydroxychloroquine medication.

Sponsors & Collaborators

• The Eye Center and The Eye Foundation for Research in Ophthalmology: lead
• King Khalid University Hospital: collaborator

Study Sites (1)

The Eye Center

Riyadh, 11534, Saudi Arabia

Location

MeSH Terms

Interventions

Visual Fields

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 8, 2019
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)