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RecruitingNCT07354009Updated Jan 21, 2026

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

An interventional study of PHACO+PC-IOL+iStent and PHACO+PC-IOL in Glaucoma, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Glaucoma

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 60 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    PHACO+PC-IOL+iStent

    Cataract extraction combined with intraocular lens implantation + istent imp

    Procedure: PHACO+PC-IOL+iStent

  • Sham comparator
    PHACO+PC-IOL

    Cataract extraction combined with intraocular lens implantation

    Procedure: PHACO+PC-IOL

Interventions

  • ProcedurePHACO+PC-IOL+iStent

    PHACO+PC-IOL+iStent

    Also known as: PHACO+PC-IOL

  • ProcedurePHACO+PC-IOL

    PHACO+PC-IOL

06

What researchers measure

Primary outcomes

  1. intraocular pressure

    intraocular pressure

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

07

Study locations

1 of 1 sites recruiting
  • Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
    Hangzhou, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07354009
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jan 21, 2026
Start date
Oct 7, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Jan 21, 2026

Study contacts

Kaijun wang, MD
Contact
wkj992@126.com
+86 0571 87783759
Kaijun Wang
study director · Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang Universit

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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