| Registry | NCT02805686, acronym OCTAPS |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, screening |
| Enrollment | 45 (Actual) |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild (Network) |
| Conditions | Maculopathy |
| Interventions | spectral domain optical coherence tomography, multifocal electroretinogram (Device) |
| Dates | start 2014-06-01, primary completion 2016-02-01, completion 2016-02-01, first posted 2016-06-20, last updated 2018-01-26 |
Related Papers Related Patents Related Grants Related Experts
All trials for Maculopathy All trials of spectral domain optical coherence tomography All trials of multifocal electroretinogram
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| "En face" OCT (C-scan) | Experimental | Device: spectral domain optical coherence tomography; Device: multifocal electroretinogram |
Sex: All, ages: 18 Years to any
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