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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Maculopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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"En face" OCT (C-scan)

Group Type EXPERIMENTAL

spectral domain optical coherence tomography

Intervention Type DEVICE

multifocal electroretinogram

Intervention Type DEVICE

Interventions

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spectral domain optical coherence tomography

Intervention Type DEVICE

multifocal electroretinogram

Intervention Type DEVICE

Eligibility Criteria

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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