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

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

Recruiting
18-90 years
All
Phase N/A

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Overview

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.

Description

Group A: Cataract extraction combined with intraocular lens implantation and iStent implantation; Group B: Cataract extraction combined with intraocular lens implantation. The Intraocular pressure changes at 1 day, 1 week, 1 month, 3 months, 6 months and 12 months were observed and compared between the two groups.

Eligibility

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 details
    Glaucoma

NCT07354009

Second Affiliated Hospital, School of Medicine, Zhejiang University

1 February 2026

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