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OpenTrials
Completed

NCT Number: NCT03316092

Monitoring and Preventing Hydroxychloroquine, Plaquenil, 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.

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Key information

Conditions

Hydroxychloroquine Toxicity

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. S.S. Michel Clinic

Edmonton, Alberta, T5R5W9, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Optical coherence tomography

Diagnostic Test

screening and monitoring all patients who are to use or have been using oral Hydroxychloroquine

Primary outcomes

  1. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dr. S.S. Michel Clinic

Other

Registry information

Official study title

Update on Monitoring and Preventing Hydroxychloroquine Toxicity.

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2017
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.