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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT06063005
Eligibility Criteria:
Inclusion Criteria:
* Participants who can understand the purpose of this clinical trial, volunteer to participate, sign an informed consent form, and can complete the postoperative follow-up on time.
* Participants diagnosed with idiopathic macular hole (IMH).
* Based on OCT scans, the minimum horizontal diameter of the macular hole is \>500 and \<900 µm.
* Participants with an axial length \<26.0mm and a myopic degree lower than 6D.
* For participants with bilateral macular holes, the eye with a larger hole diameter will be included.
Exclusion Criteria:
* Patients with the following retinal disorders: age-related macular degeneration, epi-macular membrane neovascularization, non-macular retinal tears, lesions of the retinal pigment epithelium and choroid, inherited or degenerative retinal diseases, optic neuropathies, retinal vascular diseases; patients with large macular holes accompanied by retinal detachment;
* Patients with high myopia (axial length ≥ 26.0mm and myopia exceeding 6D);
* Patients with a history of ocular trauma or retinal laser treatment;
* Patients with glaucoma, ocular infections, inflammations, tumors, corneal diseases, or amblyopia;
* Patients with contraindications to vitrectomy;
* Patients with severe or unstable systemic diseases;
* Patients with a fasting blood glucose level ≥ 9mmol/L before surgery;
* Patients who participated in other clinical trials involving drugs or medical devices within 30 days prior to screening;
* Patients with a history of intraocular surgery within 3 months prior to screening;
* Patients with reduced visual function or vision in the contralateral eye as determined by the investigator;
* Patients who are not considered suitable for enrollment by the investigator for other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT06063005
Study Brief:
Protocol Section:
NCT06063005