CompletedNot Applicable

" En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials

45 participantsStarted 2014-06

Plain-language summary

The maculopathy induced by the retinal toxicity of the synthetic antimalarials must be detected at the infra-clinical state, when it can still be reversible. Identifying early retinal anatomical changes has always represented (a challenge for medical interns, dermatologists, rheumatologists, and ophthalmologists). Currently, the gold-standard for its screening and its diagnostic is the multifocal electroretinogram (mfERG), however it is a long and tedious exam, offered by only few medical centers. It is recommended to find a simple non-invasive alternative, on a commonly used equipment. The study of the ellipsoid (junction line between, the external and internal photoreceptor segments) using optical coherence tomography (OCT-SD) "en face" enables us, to obtain a panoramic viewing of the state of the photoreceptor layer, and to detect any modification, even subtle, within this layer. The OCT-SD "en face" can be easily done by any ophthalmologist who owns one. The proportion of "en face" OCT-SD showing suggestive retinal damage and patients who present retinal damage in relation with synthetic antimalarial treatments and diagnosed by mfERG is considered in this study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients treated with synthetic antimalarials with retinal damage (in relation with the antimalarial treatment) recently diagnosed by mfERG * Patients treated with synthetic antimalarials in the past, who stopped treatment because of a supposed retinal damage not confirmed by mfERG Exclusion Criteria: \- State of ocular structures preventing the realization of exams

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

concordance between mfERG and "En-face" OCT

Timeframe: after 1 hour

Trial details

NCT IDNCT02805686

SponsorFondation Ophtalmologique Adolphe de Rothschild

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2016-02

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