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

Primary Purpose

Toxicity, Drug, Maculopathy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
spectral domain optical coherence tomography C-scan and multifocal electroretinogram
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Toxicity, Drug

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients treated with synthetic antimalarials for at least 5 years

Exclusion Criteria:

  • state of ocular structures preventing the realization of exams

Sites / Locations

  • Fondation Ophtalmique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OCT C-scan

Arm Description

Outcomes

Primary Outcome Measures

concordance between mfERG and SD OCT C-scan
measure of kappa coefficient

Secondary Outcome Measures

Full Information

First Posted
March 16, 2016
Last Updated
December 17, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02719002
Brief Title
Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials
Acronym
PERFOCTAPS
Official Title
Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 26, 2016 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxicity, Drug, Maculopathy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCT C-scan
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
spectral domain optical coherence tomography C-scan and multifocal electroretinogram
Primary Outcome Measure Information:
Title
concordance between mfERG and SD OCT C-scan
Description
measure of kappa coefficient
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients treated with synthetic antimalarials for at least 5 years Exclusion Criteria: state of ocular structures preventing the realization of exams
Facility Information:
Facility Name
Fondation Ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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

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