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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT05223205
Eligibility Criteria:
Inclusion Criteria:
* Patient must be able and willing to give informed consent.
* Patient must be between 18 and 100 years of age.
* Patient must not have any significant media opacity which interferes with the examination.
* Patient must have an (stage 1-4) idiopathic macular hole requiring surgery.
Exclusion Criteria:
* Unwilling or unable to provide informed consent
* Under 18 or over 100 years of age
* Significant media opacities
* Systemic pathologies making an examination difficult or cumbersome to the patient
* Primary and/or secondary epiretinal membranes (ERM), except incipient ERMs not affecting the foveal contour and not requiring surgery
* Full-thickness idiopathic macular hole \> 600 μm in minimum diameter
* Nonclosure
* Lamellar holes not requiring surgery
* Pseudo holes
* Glaucoma
* Diabetes
* Anisometropia \> 2 diopters
* High myopia (spherical equivalent \> 6 diopters and/or axial length \> 26 mm
* Other retinal or ophthalmic pathologies except moderate cataract
* OCTA scan signal strength \< 5
* Low image quality
* Failure of automatic layer segmentation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05223205
Study Brief:
Protocol Section:
NCT05223205