N/A
N=834
Automated Detection of Malarial Retinopathy in Patients Diagnosed With Cerebral Malaria
Cerebral Malaria · Malarial Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT06915285 ↗Enrolled (actual)
834
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Sensitivity and Specificity of ASPIRE to Detect Malarial Retinopathy in Eyes of the Subjects Clinically Diagnosed With CM — 87; 85 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Automated software for malarial retinopathy detection (Diagnostic_test)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- VisionQuest Biomedical LLC
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of ASPIRE to Detect Malarial Retinopathy in Eyes of the Subjects Clinically Diagnosed With CM |
87; 85 | — |
| SECONDARY Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of ASPIRE to Detect Malarial Retinopathy in Eyes of the Subjects Clinically Diagnosed With CM |
88; 83 | — |
Summary
The focus of the study is performance validation of ASPIRE software device in processing mydriatic retinal images of a patient with clinically diagnosed Cerebral Malaria (CM), to detect malarial retinopathy (MR). The outcome expected is the sensitivity and specificity of ASPIRE in detecting MR in patients with clinical diagnosis of CM, who may be addressed by a physician or ophthalmic specialist with follow-up and/or treatment. The reference standard for detection of MR is based on an adjudicated diagnoses by a panel of three ophthalmic graders (ophthalmologists) trained in the detection of MR in retinal images.
Eligibility Criteria
Inclusion Criteria
- 1. Pediatric patients under 21 years admitted to any one of the study sites who satisfy the standard clinical case definition of cerebral malaria according to the World health organization (WHO) criteria:
- Blantyre coma score of ≤2
- Known positive result of a malaria test for peripheral Plasmodium falciparum parasitemia (blood smear or malaria rapid diagnostic test) 2. Consent provided by parents/caregivers of the eligible pediatric patients
Exclusion Criteria
- Pediatric patients admitted who satisfy the standard clinical case definition of cerebral malaria, but there is no clinician/nurse available to do an examination within 6 hours of admission, or no consent provided by parents/caregivers.
Data sourced from ClinicalTrials.gov (NCT06915285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.