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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT05638906
Eligibility Criteria:
Inclusion Criteria:
* 1\. Male or female ≥ 18 years to ≤ 85 years old 2. Unsatisfactory IOP level, i.e., IOP ≥21 mmHg, at the screening visit in the study eye 3. Manifest open angle glaucoma (OAG) with typical disc or visual field changes and open iridocorneal angle in the study eye (in accordance with European Glaucoma Society (EGS) criteria 1) 4. Optic nerve appearance characteristic of glaucoma in the study eye 5. Shaffer grade ≥ III in all four angle quadrants in the study eye 6. Subject is treated with 0 to 5 hypotensive medications in the study eye 7. Subject is able and willing to attend all scheduled follow-up exams 8. Subject understands and signs the informed consent
Exclusion Criteria:
* 1\. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye 2. Closed angle forms of glaucoma in either eye unless scheduled for cataract surgery immediately prior to the Minimally Invasive Nasal Trabeculostomy procedure or the study eye is pseudophakic with posterior chamber intraocular lens (PCIOL) 3. Congenital or developmental glaucoma in either eye 4. Fixation threatening visual-field defects or IOP ≥40 mmHg in the study eye
1. Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye
2. Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
3. Subject has history of penetrating keratoplasty (PKP)
4. Any previous surgery in the study eye (at the access site of the Minimally Invasive Nasal Trabeculostomy System application), where the conjunctiva is not intact and elastic (except for clear corneal cataract surgery)
5. Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
6. Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemm's canal in the study eye.
7. Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye
8. History of idiopathic or autoimmune uveitis in either eye
9. Severe trauma in study eye
10. Active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil, need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month period
11. Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eye
12. Aphakia
13. Prior vitreoretinal surgery in study eye
14. Clinically significant ocular inflammation or infection within 90 days prior to screening
15. Unable to discontinue use of blood thinners in accordance with surgeon's standard preoperative instructions
16. Uncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visits
17. Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit
18. Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05638906
Study Brief:
Protocol Section:
NCT05638906