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

Recruiting now · Not applicable

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT07354009

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

60

Starts

2025-10-07

Expected to finish

2027-10-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University — Hangzhou, China (enrolling)

Full record on ClinicalTrials.gov

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