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

January 19, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kaijun Wang, MD
  • Phone Number: +86 0571 87783759
  • Email: wkj992@126.com

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
        • Contact:
          • Kaijun Wang, MD
          • Phone Number: +86 0571 87783759
          • Email: wkj992@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PHACO+PC-IOL+iStent
Cataract extraction combined with intraocular lens implantation + istent imp
Procedure: PHACO+PC-IOL+iStent
PHACO+PC-IOL+iStent
Other Names:
  • PHACO+PC-IOL
Sham Comparator: PHACO+PC-IOL
Cataract extraction combined with intraocular lens implantation
Procedure: PHACO+PC-IOL
PHACO+PC-IOL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
intraocular pressure
Time Frame: Baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months
intraocular pressure
Baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kaijun Wang, Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang Universit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-1421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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