Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials

NCT02719002 | Completed

• 1 other identifier: MMT_2015_45
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Maculopathy induced by retinal toxicity of synthetic antimalarials is to be screened at the sub-clinical stage. Indeed, when the first visual symptoms appear, macular damage is already irreversible and the clinical picture may even continue to deteriorate for several years after the end of synthetic antimalarial use. In opposition, the early termination of hydroxychloroquine in patients showing recent alterations on the multifocal electroretinogram (nfERG) allowed he reversibility of toxic damage over a six month period. It is therefore critical to detect early retinal anatomic changes during retinotoxicity screening before the occurrence of irreversible anatomical and functional consequences. The usual patient monitoring consists of an annual eye examination, detecting subjective functional abnormalities (visual acuity, color vision, central visual field testing) or macular lesions (eye fundus). These abnormalities show a constituted infringement and do not contribute to the early diagnosis of synthetic antimalarial maculopathy. The mfERG is an objective examination, able to detect retinal damage whilst still reversible. It is recommended during the annual monitoring and is, today, the gold standard for the screening and diagnosis of synthetic antimalarial maculopathy. However, its realization is time consuming, requires a good patient cooperation and is difficult to access due to the few ophthalmology centers offering it. In practice, it is rarely done as a systematic annual screening for patients on long-term synthetic antimalarial treatment. It is often limited to second-line studies (for patients already showing functional or anatomical abnormalities) whereas its interest lies in the detection of early lesions. The Optical Coherence Tomography Spectral Domain (OCT-SD) is a non-invasive eye examination, commonly used since nearly 10 years. A special image analysis provides a panoramic viewing of the state of the photoreceptor layer, and a non-invasive detection of any anatomical changes, even subtle, within this layer. The concordance between the "en face" OCT and the mfERG in the screening of synthetic antimalarial maculopathy is considered in this study.

Conditions

Toxicity, Drug; Maculopathy

Outcome Measures

Primary Outcomes (1)

• concordance between mfERG and SD OCT C-scan

  measure of kappa coefficient

  2 years

Study Arms (1)

OCT C-scan

EXPERIMENTAL

Device: spectral domain optical coherence tomography C-scan and multifocal electroretinogram

Interventions

spectral domain optical coherence tomography C-scan and multifocal electroretinogram DEVICE

OCT C-scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients treated with synthetic antimalarials for at least 5 years

You may not qualify if:

• state of ocular structures preventing the realization of exams

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• Marques Dias JI, Chevalier K, Vasseur V, Laumonier E, Derrien S, Morel N, Le Guern V, Mathian A, Mouthon L, Mauget Faysse M, Nguyen Y, Costedoat-Chalumeau N. Comparison of flares in 85 patients with SLE who maintained, discontinued or reduced dose of hydroxychloroquine during a prospective study of ophthalmological screening for retinopathy (PERFOCTAPS Study). Lupus Sci Med. 2025 Mar 12;12(1):e001434. doi: 10.1136/lupus-2024-001434.

  PMID: 40081891 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Macular Degeneration

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 24, 2016
• Study Start: August 26, 2016
• Primary Completion: February 18, 2021
• Study Completion: May 15, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Locations

FR (1)