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:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT03020459
Eligibility Criteria:
Inclusion Criteria:
* The patients are diagnosed as macular hole by optical coherence tomography.
* Age ranges from 50 to 80 years.
* The patients have indication for surgery.
Exclusion Criteria:
* Traumatic macular hole.
* Combined with serious epiretinal membrane.
* Combined with diabetic retinopathy, hypertensive retinopathy.
* Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.
* \- 6.0 diopters or more of spherical equivalent, 26mm or more of axial length.
* History of intraocular surgery.
* Presence of staphyloma.
* Other ocular diseases that could influence macular microstructure or visual function
Exit criteria:
* For reposition group, the patients will exit the research if the peeled ILM cannot reposition successfully.
* Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;
* Drop out;
* The patients voluntarily withdraw the informed consent;
* Serious violation of the study protocol due to the subjects or investigators' reasons;
* Other reasons that the researchers believe for quitting the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT03020459
Study Brief:
Protocol Section:
NCT03020459