Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT07291960
Eligibility Criteria:
Inclusion Criteria:
Clinician Participants (Report Writers)
1. Board-certified ophthalmologists or ophthalmology trainees (registrars or fellows) with clinical experience in interpreting fundus images.
2. Capable of independently completing retinal clinical reports based on fundus photography.
3. Willing and able to participate in the study tasks (report writing) under assigned study conditions.
4. Able to provide informed consent.
Expert Evaluators (Outcome Assessors)
1. Senior ophthalmologists with at least 5 years of post-certification clinical experience.
2. Not involved in the report-writing stage of the study.
3. Willing to evaluate de-identified reports across predefined quality dimensions.
4. Able to provide informed consent.
Fundus Images (Data Inputs)
1. Retinal fundus photographs of sufficient quality for clinical interpretation.
2. Images representing a range of common retinal findings (normal or abnormal).
3. Previously collected, de-identified images with no patient-identifiable information.
Exclusion Criteria:
Clinician Participants
1. Lack of experience in interpreting fundus images (e.g., interns, medical students).
2. Prior involvement in the development, training, or validation of the AI system being tested.
3. Inability to complete reporting tasks due to time constraints or technical limitations.
4. Any condition that may interfere with ability to perform study tasks (e.g., prolonged absence).
Expert Evaluators
1. Participation in the intervention or control reporting arms.
2. Prior exposure to or involvement in development of the AI system.
3. Any conflict of interest affecting impartiality of report quality evaluation.
Fundus Images
1. Poor-quality images with insufficient clarity for interpretation.
2. Images containing artifacts or cropping that prevent accurate segmentation or assessment.
3. Images with any remaining patient identifiers (excluded to maintain confidentiality).
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT07291960
Study Brief:
Protocol Section:
NCT07291960