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

Not Applicable

Completed

• Conditions: Maculopathy
• Interventions: Device: spectral domain optical coherence tomography; Device: multifocal electroretinogram

• Registration Number: NCT02805686
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"En face" OCT (C-scan)	spectral domain optical coherence tomography	-
"En face" OCT (C-scan)	multifocal electroretinogram	-

Primary Outcome Measures

Name	Time	Method
concordance between mfERG and "En-face" OCT	after 1 hour	measure of kappa coefficient