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Clinical Trials in China / NCT07354009
Recruiting Not applicable

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

NCT07354009 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2025-10-07
Last updated
2026-01-21

Condition(s) studied

Glaucoma

Investigational drug(s) / intervention(s)

PHACO+PC-IOL+iStentPHACO+PC-IOL

PHACO+PC-IOL+iStent: PHACO+PC-IOL+iStent

PHACO+PC-IOL: PHACO+PC-IOL

Study 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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University Hangzhou China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07354009 on ClinicalTrials.gov ↗ ← All trials in China