Actively Recruiting

Age: 20Years +
All Genders
Healthy Volunteers
ID06287645

Development of Digital Fundus Images Dataset of Local Population of Pakistan

Led by Pakistan Council of Scientific and Industrial Research · Updated on 2024-03-07

50000

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

P

Pakistan Council of Scientific and Industrial Research

Lead Sponsor

A

Al-Ibrahim Eye Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are creating a detailed digital retinal image dataset from people in Pakistan, focusing on diabetic retinopathy and other retinal diseases. The aim is to support better research and improve patient care by providing images graded by three eye specialists. These experts assess the severity of diabetic retinopathy and other conditions using recognized clinical scales to ensure accurate and reliable data. Participants will have retinal images taken using a color fundus camera without pupil dilation. Three vitreoretinal specialists will independently grade these images for various retinal conditions, including different stages of diabetic retinopathy and macular edema. Final decisions on each image's grading will be made by unanimous agreement among all graders. During the study, participants will undergo a single visit for retinal imaging and grading. The main outcomes measured include the severity of diabetic retinopathy according to international clinical scales and the agreement among the three specialists over two years. This study welcomes adult participants aged 20 years or older with diabetes and will help advance eye disease research in the local population.

CONDITIONS

Brief Title

Color Fundus Photograph With Experts Labelling

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Type I or Type II Diabetes.
  • Patients of age of 20 years or above
Not Eligible

You will not qualify if you...

  • The participant is unable or unwilling to comply with study procedures.
  • Vulnerable participants (minors, legally detained individuals).
  • Prisoners or subjects who are involuntarily incarcerated.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo retinal imaging using fundus cameras to capture digital fundus photographs. The images will be graded by three specialists for various retinal disorders and diagnostic clarity.

1 visit (in-person)

Long-term Monitoring

Duration - 2 years

The grading results from the retinal images are used to assess inter-rater agreement among the specialists over a period of two years.

Follow-up assessments as needed over 2 years

Trial Site Locations

Total: 1 location

1

Al Ibrahim Eye Hospital

Karachi, Pakistan

Actively Recruiting

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Research Team

G

Ghulam Mustafa

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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