Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.

Completed

• Conditions: Hydroxychloroquine Toxicity

• Registration Number: NCT03316092
• Lead Sponsor: Dr. S.S. Michel Clinic

Brief Summary

Oral Hydoxychloroquine is a very popular medication widely used by patients with rheumatoid arthritis, Systemic Lupus Erythematosus and other diseases. Ocular side effects of this medication are very serious and causes loss of central vision. In most patients these side effects are dose related, cumulative. This means that the risk of side effects would increase in all patients with continued use of the medication. In few people use of the medication would not be recommended if they have some bilateral macular problems. This is because the side effects of this medication does cause serious degredation of the macula in both eyes.

Detailed Description

The ocular side effects of Hydroxychloroquine has been known for long time. Due to the seriousness of these side effects all possible efforts were done to prevent them. Preventing these side effects would ideally need prior screening of all patients who are to use oral Hydroxychloroquine. If patients are not screened prior to oral Hydroxychloroquine use they should be examined as soon as possible after starting this medication. Advances in technology, specifically the advent of optical coherence tomography, made screening and monitoring for Hydroxychloroquine toxicity much more easier and reliable meantime.

Study Timeline

• Study Start: 2010-01-07
• Primary Completion: 2017-01-10
• Status Verified: 2017-10
• Study Completion: 2017-10-10
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Last Update Submitted: 2017-10-19
• Study First Posted: 2017-10-20
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

all patients who need treatment with oral Hydroxychloroquine.

Exclusion Criteria

patients who are not using oral Hydroxychloroquine.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
optical coherence tomography (OCT) is a very reliable, accessible and documented way for monitoring all people who are to use or have been using oral Hydroxychloroquine	Ten years	OCT would very much help in selecting patients who may safely use oral Hydroxychloroquine. It is also the most preferred way so far for monitoring all patients who use oral Hydroxychloroquine to prevent serious and bilateral ocular side effects

Trial Locations

Locations (1)

Dr. S.S. Michel Clinic; 🇨🇦 Edmonton, Alberta, Canada