Using AI to detect and predict eye damage from hydroxychloroquine
| ISRCTN | ISRCTN11308648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11308648 |
- Submission date
- 16/02/2025
- Registration date
- 20/02/2025
- Last edited
- 20/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Hydroxychloroquine is a medication that can cause eye damage (retinal toxicity) in some patients. Detecting this damage early is difficult and depends on the doctor's interpretation of various eye tests. This study aims to use artificial intelligence (AI) to automate the analysis of these tests, making it easier to detect eye damage early and reduce the workload for eye doctors.
Who can participate?
Patients who have been taking hydroxychloroquine for more than 10 years are eligible to participate in this study.
What does the study involve?
Participants will undergo the same eye tests that are typically used to screen for hydroxychloroquine toxicity. These tests include fundus photography and optical coherence tomography with autofluorescence. The data collected will be anonymized and analyzed using AI to detect any signs of eye damage.
What are the possible benefits and risks of participating?
There are no risks associated with participating in this study, as the tests performed are standard procedures. Participants may benefit from early detection of eye damage if the AI algorithm proves to be successful.
Where is the study run from?
Centro Hospitalar de Lisboa Central (Portugal)
When is the study starting and how long is it expected to run for?
August 2023 to February 2025
Who is funding the study?
The study is funded by grants from Grupo de Estudos de Retina, Sociedade Portuguesa de Oftalmologia, Centro Hospitalar de Lisboa Central, and Alphasigma (Portugal)
Who is the main contact?
Rita Anjos, rita.s.anjos@gmail.com
Contact information
Public, Scientific, Principal Investigator
R. José António Serrano
Lisboa
1150-199
Portugal
 ORCID ID |
0000-0002-9058-5836 |
|---|---|
| Phone | +351 935619454 |
| Rita.anjos@ulssjose.min-saude.pt |
Study information
| Study design | Observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Artificial intelligence in the detection and prediction of hydroxychloroquine maculopathy |
| Study acronym | PLAQUINAI |
| Study objectives | We hypothesize that HCQ toxicity can be detected with a deep learning system with OCT |
| Ethics approval(s) |
Approved 28/12/2023, Ethics commission of Centro Hospitalar de Lisboa Central (R. José António Serrano, 1150-199 Lisboa, Lisboa, 1150-199, Portugal; +351914535963; rita.s.anjos@gmail.com), ref: 1304/2022 |
| Health condition(s) or problem(s) studied | Hydroxychloroquine maculopathy |
| Intervention | Patients on long-term hydroxychloroquine (HCQ) therapy will have an optical coherence tomography (OCT) examination. Controls (no HCQ maculopathy) and toxicity (HCQ maculopathy) will be selected. OCT scans will be analysed by RETINAI algorithm. |
| Intervention type | Other |
| Primary outcome measure | Age, sex, weight, total cumulative HCQ/CHLOROQUINE dose; daily HCQ/CHLOROQUINE dose, time of HCQ/CHLOROQUINE use, baseline disease for HCQ/CHLOROQUINE , Other systemic diseases, Steroid use and dose, immunosuppressant, other medications and dose, ocular disease, ocular medication collected from patients notes as well as interviews during normal consultations |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/08/2023 |
| Completion date | 20/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Case group: Patients with diagnosis of HCQ or Chloroquine toxicity Control group: Patients with > 10 years of HCQ intake |
| Key exclusion criteria | Patients with ocular diseases that may mimic HCQ maculopathy or interfere with its screening |
| Date of first enrolment | 01/08/2024 |
| Date of final enrolment | 19/02/2025 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Lisboa
1150-199
Portugal
Sponsor information
Hospital/treatment centre
R. José António Serrano
Lisbon
1150-199
Portugal
| Phone | +351 213 596 402 |
|---|---|
| projetos.inv@chlc.min-saude.pt | |
| Website | http://www.chlc.min-saude.pt/homepage.aspx?menuid=1 |
"ROR" |
https://ror.org/00k6r3f30 |
Funders
Funder type
Research organisation
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Rita Anjos rita.s.anjos@gmail.com |
Editorial Notes
17/02/2025: Trial's existence confirmed by Ethics commission of Centro Hospitalar de Lisboa Central.
