NCT07354009

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Oct 2025Oct 2027

Study Start

First participant enrolled

October 7, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 21, 2026

Status Verified

October 1, 2025

Enrollment Period

12 months

First QC Date

November 17, 2025

Last Update Submit

January 19, 2026

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    intraocular pressure

    Baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months

Study Arms (2)

PHACO+PC-IOL+iStent

EXPERIMENTAL

Cataract extraction combined with intraocular lens implantation + istent imp

Procedure: PHACO+PC-IOL+iStent

PHACO+PC-IOL

SHAM COMPARATOR

Cataract extraction combined with intraocular lens implantation

Procedure: PHACO+PC-IOL

Interventions

PHACO+PC-IOL+iStentPROCEDURE

PHACO+PC-IOL+iStent

Also known as: PHACO+PC-IOL
PHACO+PC-IOL+iStent
PHACO+PC-IOLPROCEDURE

PHACO+PC-IOL

PHACO+PC-IOL

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Kaijun Wang

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

    STUDY DIRECTOR

Central Study Contacts

Kaijun wang, MD

CONTACT

+86 0571 87783759wkj992@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

January 21, 2026

Study Start

October 7, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

January 21, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)