Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.

Sponsor

Dr. S.S. Michel Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03316092

Collaborator

(none)

1,000

Enrollment

Location

93.1

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hydroxychloroquine Toxicity	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 Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Update on Monitoring and Preventing Hydroxychloroquine Toxicity.

Actual Study Start Date :

Jan 7, 2010

Actual Primary Completion Date :

Jan 10, 2017

Actual Study Completion Date :

Oct 10, 2017

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 85 Years

Sexes Eligible for Study:

All

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

Exclusion Criteria: patients who are not using oral Hydroxychloroquine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. S.S. Michel Clinic	Edmonton	Alberta	Canada	T5R5W9

Sponsors and Collaborators

Dr. S.S. Michel Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Shawkat Michel, Principal Investigator, Dr. S.S. Michel Clinic

ClinicalTrials.gov Identifier:

NCT03316092

Other Study ID Numbers:

Ocular Plaquenil Toxicity

First Posted:

Oct 20, 2017

Last Update Posted:

Oct 23, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 23, 2017