GlaucomaNCT07354009
Efficacy and Safety of iStent in Reducing Intraocular Pressure in Open-angle Glaucoma
A study testing PHACO+PC-IOL+iStent and PHACO+PC-IOL in people with Glaucoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- PHACO+PC-IOL+iStent and PHACO+PC-IOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
Hangzhou
Kaijun Wang, MD, +86 0571 87783759, wkj992@126.com
About this study
Official title: 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.
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.
- Conditions
- Glaucoma
- Being tested
- PHACO+PC-IOL+iStent, PHACO+PC-IOL
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHACO+PC-IOL+iStentProcedure or surgery
Also called PHACO+PC-IOL
PHACO+PC-IOL+iStent
PHACO+PC-IOLProcedure or surgery
PHACO+PC-IOL
| Study group | Role | What they receive |
|---|---|---|
| PHACO+PC-IOL+iStent | Experimental | Cataract extraction combined with intraocular lens implantation + istent imp Receives: Procedure: PHACO+PC-IOL+iStent |
| PHACO+PC-IOL | Sham comparator | Cataract extraction combined with intraocular lens implantation Receives: Procedure: PHACO+PC-IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
intraocular pressure
Measured: Baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start7 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaijun Wang, Study director, Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang Universit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354009
- Sponsor's protocol ID
- 2025-1421
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of iStent in Reducing Intraocular Pressure in Adult Patients With Open-angle Glaucoma and Cataract
- ClinicalTrials.gov ID
- NCT07354009
- Acronym / sponsor ID
- 2025-1421
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHACO+PC-IOL+iStent | Experimental | Procedure: PHACO+PC-IOL+iStentCataract extraction combined with intraocular lens implantation + istent imp |
| PHACO+PC-IOL | Sham comparator | Procedure: PHACO+PC-IOLCataract extraction combined with intraocular lens implantation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHACO+PC-IOL+iStentAlso: PHACO+PC-IOLPHACO+PC-IOL+iStent | Procedure or surgery | PHACO+PC-IOL+iStent |
| PHACO+PC-IOLPHACO+PC-IOL | Procedure or surgery | PHACO+PC-IOL |
Primary outcome
intraocular pressure
Time frame: Baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months
intraocular pressure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaijun Wang study director
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang Universit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHACO+PC-IOL+iStent and PHACO+PC-IOL in people with Glaucoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaijun wang, MD (+86 0571 87783759, wkj992@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: Baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.