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Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.

Update on Monitoring and Preventing Hydroxychloroquine Toxicity.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03316092
Enrollment
1000
Registered
2017-10-20
Start date
2010-01-07
Completion date
2017-10-10
Last updated
2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydroxychloroquine Toxicity

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.

Interventions

DIAGNOSTIC_TESToptical coherence tomography

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

Sponsors

Dr. S.S. Michel Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 85 Years

Inclusion criteria

all patients who need treatment with oral Hydroxychloroquine. \-

Exclusion criteria

patients who are not using oral Hydroxychloroquine. \-

Design outcomes

Primary

MeasureTime frameDescription
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 HydroxychloroquineTen yearsOCT 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026