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Efficacy and Safety of iStent in Reducing Intraocular Pressure in Open-angle Glaucoma

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.

ClinicalTrials.gov IDNCT07354009
PhaseNA
Enrollment60
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Age18 Years
SexALL
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Conditions studied

Glaucoma

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.