Retinal DiseaseNCT06287645
Color Fundus Photograph With Experts Labelling
An observational study of Retinal Disease and Diabetic Retinopathy, run by Pakistan Council of Scientific and Industrial Research at 1 site in Pakistan.
Trial summary
This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Diabetic Retinopathy
- What is being tested?
- Color Fundus Photography/Non-Mydriatic Opthalmic Cameras
- How many people
- 50,000 participants
- Where
- 1 sitePakistan
- Study dates
- 12 May 2022to 30 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting the diabetic eye care center at our collaborated hospital will be registered for this study.
Who may be able to join
- Patients with Type I or Type II Diabetes.
- Patients of age of 20 years or above
Who cannot join
- The participant is unable or unwilling to comply with study procedures.
- Vulnerable participants (minors, legally detained individuals).
- Prisoners or subjects who are involuntarily incarcerated.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Al Ibrahim Eye Hospital
Karachi
Ghulam Mustafa, mustafabme@gmail.com
About this study
Official title: Development of Digital Fundus Images Dataset of Local Population of Pakistan
This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care.
Read the detailed description
This clinical trial aims to address the scarcity of retinal image datasets in Pakistan by providing a comprehensive digital fundus photograph dataset, accompanied by expert grading. The dataset will encompass retinal images from Pakistani individuals, meticulously labeled by three Vitreo Retinal Specialists. These specialists will assess the presence and severity of common retinal disorders, including No Diabetic Retinopathy (No DR), Mild, Moderate, Severe, Proliferative Diabetic Retinopathy, Clinically Significant Macular Edema (CSME), and Advance diabetic Eye Diseases (ADED). Each image will also be evaluated for diagnostic clarity and the presence of any additional findings. Final grading decisions will be reached through unanimous consensus among the graders, ensuring the dataset's reliability and accuracy. This initiative holds promise for advancing ophthalmic research and improving patient care in Pakistan and beyond.
- Conditions
- Retinal Disease, Diabetic Retinopathy
- Being tested
- Color Fundus Photography/Non-Mydriatic Opthalmic Cameras
- Medical subject headings
- Retinal Diseases, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color Fundus Photography/Non-Mydriatic Opthalmic CamerasDiagnostic test
Participants will undergo retinal imaging by fundus camera. Three specialists will independently grade images for common retinal disorders like Diabetic Retinopathy. Final grading decisions will be unanimous among the specialists.
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale
Each Fundus photograph will be evaluated according to the Severity of Diabetic Retinopathy following International Clinical Diabetic Retinopathy Severity Scale (ICDRSS). Following Diabetic Retinopathy symptoms will be graded according to this scale.
- No DR
- Mild
- Moderate
- Severe
- Proliferative
Measured: 1 Visit (1 day)
Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale
Each Fundus photograph will be evaluated according to the Severity of Diabetic Retinopathy following Early Treatment of Diabetic Retinopathy Scale (ETDRS). Following Diabetic Retinopathy symptoms will be graded according to this scale.
- Clinically Significant Macular Edema
- Advance Diabetic Eye Disease
Measured: 1 Visit (1 day)
Finding inter-rater agreement among the graders
The intraclass correlation coefficient will be calculated using the collected dataset to assess the consistency in grading among all graders.
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start12 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pakistan Council of Scientific and Industrial Research
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Ibrahim Eye Hospital
- Responsible party
- Sponsor
- Investigators
- Ghulam Mustafa, Principal investigator, Pakistan Council of Scientific and Industrial Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287645
- Sponsor's protocol ID
- Retinal Images Dataset
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Digital Fundus Images Dataset of Local Population of Pakistan
- ClinicalTrials.gov ID
- NCT06287645
- Acronym / sponsor ID
- Retinal Images Dataset
- Conditions
- Retinal Disease, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Pakistan Council of Scientific and Industrial ResearchUniversity, hospital or other
- Collaborators
- Al-Ibrahim Eye Hospital
- Study start
- 12 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care.
Detailed description
This clinical trial aims to address the scarcity of retinal image datasets in Pakistan by providing a comprehensive digital fundus photograph dataset, accompanied by expert grading. The dataset will encompass retinal images from Pakistani individuals, meticulously labeled by three Vitreo Retinal Specialists. These specialists will assess the presence and severity of common retinal disorders, including No Diabetic Retinopathy (No DR), Mild, Moderate, Severe, Proliferative Diabetic Retinopathy, Clinically Significant Macular Edema (CSME), and Advance diabetic Eye Diseases (ADED). Each image will also be evaluated for diagnostic clarity and the presence of any additional findings. Final grading decisions will be reached through unanimous consensus among the graders, ensuring the dataset's reliability and accuracy. This initiative holds promise for advancing ophthalmic research and improving patient care in Pakistan and beyond.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the diabetic eye care center at our collaborated hospital will be registered for this study.
Key inclusion criteria (2 listed)
- Patients with Type I or Type II Diabetes.
- Patients of age of 20 years or above
Key exclusion criteria (3 listed)
- The participant is unable or unwilling to comply with study procedures.
- Vulnerable participants (minors, legally detained individuals).
- Prisoners or subjects who are involuntarily incarcerated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Color Fundus Photography/Non-Mydriatic Opthalmic CamerasParticipants will undergo retinal imaging by fundus camera. Three specialists will independently grade images for common retinal disorders like Diabetic Retinopathy. Final grading decisions will be unanimous among the specialists. | Diagnostic test | – |
Primary outcome
Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale
Time frame: 1 Visit (1 day)
Each Fundus photograph will be evaluated according to the Severity of Diabetic Retinopathy following International Clinical Diabetic Retinopathy Severity Scale (ICDRSS). Following Diabetic Retinopathy symptoms will be graded according to this scale. 1. No DR 2. Mild 3. Moderate 4. Severe 5. Proliferative
Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale
Time frame: 1 Visit (1 day)
Each Fundus photograph will be evaluated according to the Severity of Diabetic Retinopathy following Early Treatment of Diabetic Retinopathy Scale (ETDRS). Following Diabetic Retinopathy symptoms will be graded according to this scale. 1. Clinically Significant Macular Edema 2. Advance Diabetic Eye Disease
Finding inter-rater agreement among the graders
Time frame: Two Years
The intraclass correlation coefficient will be calculated using the collected dataset to assess the consistency in grading among all graders.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghulam Mustafa principal investigator
Pakistan Council of Scientific and Industrial Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease and Diabetic Retinopathy, run by Pakistan Council of Scientific and Industrial Research at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghulam Mustafa (+923322340395, mustafabme@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale (time frame: 1 Visit (1 day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.