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JARVISDHL Screening Tools

NCT05626517 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2022-11-23

No results posted yet for this study

Summary

The main purpose of this study is to pioneer an easy risk stratification tools, which is developed using novel artificial intelligence (AI) algorithms, that will be able to detect common and fatal heart diseases easily simply through a picture of the back of the eye, the retina. The retinal images will be analysed using a computer application with the risk stratification tool to predict health outcome of individual. The study also aims to correlate between clinical characteristics, lifestyle (eg. exercise, sleep, erectile dysfunction) and diet to retinal and coronary vasculature and clinical outcomes.

Conditions

Interventions

DIAGNOSTIC_TEST

Ocular Imaging

The retinal photography will be acquired from macula-centre and an optic-disc centre for both left and right eye after their cardiac assessment. Patient will be required to focus at a target inside the machine for approximately 5 to 10 seconds, with a flash followed at the end when eye image is captured. Based on patients' eye conditions, additional or less images may be taken. This allows a snapshot of both retinal and coronary vessels at a single point in time, no mydriatic drops will be used. Participants will be given the option to undergo mydriatic photographs of the retina at SNEC/SERI depending on participant eye condition. For mydriatic photograph, images will be obtained after pupil dilation and graded for presence and severity of diabetic retinopathy according to the modified ETDRS system and other retinal abnormalities by trained graders.

OTHER

Questionnaires

3 to 4 questionnaires will be administered (i.e. EQ5D, International Index of Erectile Function, Pittsburgh Sleep Quality Index, General Questionnaire) to investigate the correlation between clinical characteristics, lifestyle (eg. exercise, sleep, erectile dysfunction) and diet to retinal and coronary vasculature and outcomes.Only male patients who are literate in English language will be invited to complete the International Index of Erectile Function (IIEF) questionnaire. Participants have the option to not complete the whole IIEF questionnaire or some of the questions if they are not comfortable with answering those questions.

Sponsors & Collaborators

  • Singapore Eye Research Institute

    collaborator OTHER

  • National Heart Centre Singapore

    lead OTHER

Principal Investigators

  • Gavin Tan Siew Wei · Singapore National Eye Centre

  • Weiting Huang · National Heart Centre Singapore

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2024-06-30
Completion
2027-06-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626517 on ClinicalTrials.gov