Automated Detection of Malarial Retinopathy in Patients Diagnosed With Cerebral Malaria

NCT06915285 | Completed Results

• 1 other identifier: SB1AI162452
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Malaria; Malarial Retinopathy

Keywords

Malarial retinopathy; Cerebral malaria; Automated screening

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of ASPIRE to Detect Malarial Retinopathy in Eyes of the Subjects Clinically Diagnosed With CM

  The primary endpoint is the non-inferiority test for sensitivity and specificity (with two-sided 95% confidence intervals or CIs) of ASPIRE to detect malarial retinopathy in eyes of the subjects clinically diagnosed with CM, when compared to the reference standard. ASPIRE and the ophthalmic grader panel (reference standard) give their outputs based on the analysis of a set of retinal fundus photographs captured with mydriasis from the study subjects, that are compared to calculate ASPIRE's performance.

  Through the study completion, an average of 2 years

Secondary Outcomes (1)

• Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of ASPIRE to Detect Malarial Retinopathy in Eyes of the Subjects Clinically Diagnosed With CM

  Through the study completion, an average of 2 years

Study Arms (1)

Automated detection of malarial retinopathy in patients diagnosed with cerebral malaria

EXPERIMENTAL

All recruited patients are subjected to retinal imaging using Vistaview retinal camera. The retinal images for each patient are processed by ASPIRE software. As per ASPIRE's image quality analysis (IQA) protocol, each image is processed by the IQA algorithm to determine a probability score for the image to have adequate quality. The algorithm for malarial retinopathy (MR) detection requires at least four images with clinically acceptable/adequate quality to complete the processing. The MR detection algorithm uses the adequate quality case to determine the probability of detecting MR by combining individual MR probability scores of all adequate quality images obtained from the patient. The result for each clinically diagnosed CM patient is either "Malarial retinopathy detected", "Malarial retinopathy not detected", or "Inadequate photo quality" when adequate-quality images are not present. The ASPIRE results for each patient are compared to the clinical reference standard.

Diagnostic Test: Automated software for malarial retinopathy detection

Interventions

Automated software for malarial retinopathy detection DIAGNOSTIC_TEST

ASPIRE mobile application (App) software is intended to perform computer-aided detection of malarial retinopathy (MR) in digital retinal images of clinically diagnosed cerebral malaria (CM) patients under 21 years of age, to be used by a healthcare provider (user) with basic training, in primary care settings such as healthcare clinics and hospitals. The mobile Application hosts a software module developed using Deep-Learning algorithms to analyze digital retinal images of diagnosed CM patients for features suggestive of malarial retinopathy. ASPIRE requires at least four adequate quality retinal images (as determined by the image quality analysis software) captured from a patient to process it for MR detection. ASPIRE outputs a screening result of "Malarial retinopathy detected" or "Malarial retinopathy not detected" to the user. ASPIRE software is designed and validated to perform at clinically acceptable sensitivity and specificity in the detection of MR.

Automated detection of malarial retinopathy in patients diagnosed with cerebral malaria

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VisionQuest Biomedical LLC: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Kamuzu University of Health Sciences: collaborator
• Federal Ministry of Health, Nigeria: collaborator

Study Sites (1)

Mlambe mission hospital

Mlambe, Malawi

Location

Related Publications (24)

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MeSH Terms

Conditions

Malaria, Cerebral

Condition Hierarchy (Ancestors)

Central Nervous System Protozoal Infections; Central Nervous System Parasitic Infections; Central Nervous System Infections; Infections; Parasitic Diseases; Malaria; Protozoan Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Vinayak Joshi
• Organization: VisionQuest Biomedical Inc

vjoshi@visionquest-bio.com

3054845674

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 8, 2025
• Study Start: March 15, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)