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NCT Number: NCT07354009

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University

Hangzhou, China

Location status: Recruiting

Location contact

Kaijun Wang, MD

CONTACT

[email protected]

+86 0571 87783759

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PHACO+PC-IOL+iStent

Procedure

PHACO+PC-IOL+iStent

Other names: PHACO+PC-IOL

PHACO+PC-IOL

Procedure

PHACO+PC-IOL

Primary outcomes

  1. intraocular pressure

    Time frame: Baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months

    intraocular pressure

Study contacts

Contact information is provided by the study sponsor or research team.

Kaijun wang, MD

CONTACT

[email protected]

+86 0571 87783759

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Evaluation of the Efficacy and Safety of iStent in Reducing Intraocular Pressure in Adult Patients With Open-angle Glaucoma and Cataract

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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