NCT07354009 Efficacy and Safety of iStent in Reducing Intraocular Pressure in Open-angle Glaucoma
| NCT ID | NCT07354009 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-07 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-10-07 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the efficacy and safety of istent inject W in reducing intraocular pressure in Chinese adult patients with open-angle glaucoma complicated with cataract.
Eligibility Criteria
Inclusion Criteria: * Gender is not limited. Applicants must be 18 years old or above; * Study patients whose eyes were diagnosed with open-angle glaucoma; * The study eye was diagnosed with cataract and met the conditions for phacoemulsification, with the best corrected visual acuity ≤0.7(patients with the best corrected visual acuity \>0.7 who were determined by the researcher to need cataract surgery could be enrolled); * Angular endoscopy confirmed that the opening Angle of the study eye was normal (defined as Shaffer grade ≥3, and there was no peripheral anterior iris adhesion, polycythemia or other abnormal conditions that might affect the correct placement of the stent); * The patient is capable and willing to provide written informed consent and participate in the regular postoperative follow-up as required. Exclusion Criteria: * Patients with angle-closure, pigmentary or pseudo-exfoliative glaucoma; * Patients with traumatic, malignant uveitis, neovascular or glaucoma related to vascular diseases; * Suffering from severe diabetic retinopathy, retinal detachment, central retinal vein or artery occlusion, retinal chromosomal degeneration, macular degeneration, macular edema, and determined by researchers to potentially affect surgical safety; * Patients with identifiable congenital abnormalities of the anterior chamber Angle; * Having clinically significant corneal dystrophy, active inflammation or having undergone surgery that may interfere with the reliability of intraocular pressure measurement; * Patients with retrobulbar tumors, thyroid eye disease, cavernous sinus fistula, Sturge-Weber syndrome or any other disease that may cause elevated venous pressure in the outer sclera; * Suffering from eye or systemic diseases that affect surgical safety or subsequent examinations; * Pregnant women, lactating women, women of childbearing age who plan to get pregnant during the research period or are unable to take effective contraceptive measures; * Failure to follow the doctor's advice; * Other circumstances where the researcher determines that the patient is not suitable for inclusion
Contact & Investigator
Kaijun Wang
STUDY DIRECTOR
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang Universit
Frequently Asked Questions
Who can join the NCT07354009 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07354009 currently recruiting?
Yes, NCT07354009 is actively recruiting participants. Contact the research team at wkj992@126.com for enrollment information.
Where is the NCT07354009 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07354009 clinical trial?
NCT07354009 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Kaijun Wang at Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang Universit. The trial plans to enroll 60 participants.