Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.

Update on Monitoring and Preventing Hydroxychloroquine Toxicity.

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.

Study Overview

• Status: Completed
• Conditions: Hydroxychloroquine Toxicity
• Intervention / Treatment: Diagnostic test: optical coherence tomography

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5R5W9
      • Dr. S.S. Michel Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients whose doctors decide to treat them with oral Hydroxychloroquine. This medication is very popular in treating patients with rheumatoid arthritis and some other auto-immune diseases.

Description

Inclusion Criteria: all patients who need treatment with oral Hydroxychloroquine.

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Exclusion Criteria: patients who are not using oral Hydroxychloroquine.

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Ten years

Collaborators and Investigators

• Sponsor: Dr. S.S. Michel Clinic
• Investigators: Principal Investigator: shawkat s michel, FRCS Ed, Dr. S.S. Michel Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2010
• Primary Completion (Actual): January 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Ocular Plaquenil Toxicity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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