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

Maculopathy Clinical Trial

— OCTAPS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805686
• Other study ID #: MMT_2014-7
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: January 24, 2018
• Start date: June 2014
• Est. completion date: February 2016

Study information

• Verified date: January 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maculopathy

Intervention

Device:
• spectral domain optical coherence tomography

• multifocal electroretinogram

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance between mfERG and "En-face" OCT	measure of kappa coefficient	after 1 hour