Deep Learning in the Detection and Prediction of Hydroxychloroquine Maculopathy

NCT06839443 | Recruiting

• 1 other identifier: CHULC.CI.638.2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Hydroxychloroquine retinal toxicity affects a significant number of patients using this medication. Detection of toxicity is difficult in the early stages of the disease and depends on the subjectivity of the clinician who reads the tests (optical coherence tomography, autofluorescence and visual fields). Automating the reading of these diagnostic exams could lead to earlier detection of this pathology and reduce the burden associated with interpreting these exams in the ophthalmology service. The images that are usually taken in the screening and monitoring of hydroxychloroquine toxicity by will be collected - photography of the ocular fundus and optical coherence tomography with autofluorescence.

Conditions

Hidroxicloroquine Intake

Keywords

Hidroxicloroquine maculopathy; Hidroxicloroquine toxicity

Outcome Measures

Primary Outcomes (1)

• To develop an automated screening method in hydroxychloroquine (HCQ) screening based on OCT features

  We hypothesize that HCQ toxicity can be detected with a deep learning system with OCT

  One year

Secondary Outcomes (1)

• To explore early changes of toxicity in HCQ-user patients using deep learning

  One year

Study Arms (2)

Retinopathy group

Patients with HCQ intake with retinopathy

Diagnostic Test: Retinopathy group

Control group

Patients with HCQ intake without retinopathy

Diagnostic Test: Control group

Interventions

Retinopathy group DIAGNOSTIC_TEST

OCT scans and Retinai algorithm will be performed

Retinopathy group

Control group DIAGNOSTIC_TEST

OCT scans and Retinai algorithm will be performed

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HCQ intake

You may qualify if:

• Patients with \> 10 years of HCQ intake

You may not qualify if:

• Patients with ocular diseases that might mimic HCQ maculopathy or interfer with HCQ maculopathy screening

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead

Study Sites (1)

Local de Saúde São José

Portugal, 1150-199, Portugal

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dense macular OCT scans focusing on the retina and RPE will be analysed by the Retinai algorithm.

Study Officials

• Rita Anjos, MD

  ULS São José

  STUDY CHAIR

Central Study Contacts

Rita Anjos, MD

CONTACT

+351 914535963; RITA.Anjos@gmail.com

Ana Luisa Basílio, MD

CONTACT

+351 96557040; a.luisabasilio@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: August 1, 2024
• Primary Completion: April 20, 2025
• Study Completion: June 20, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

PT (1)