iStent with cataract surgery to lower eye pressure in open-angle glaucoma

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

This trial will see if placing an iStent during cataract surgery helps lower eye pressure in adults with open-angle glaucoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07354009 on ClinicalTrials.gov

What this trial studies

This interventional trial compares outcomes after cataract surgery with and without the iStent device in adults who have open-angle glaucoma and a cataract. One group undergoes phacoemulsification with intraocular lens implantation plus iStent implantation, and the other group undergoes phacoemulsification with intraocular lens implantation alone. Intraocular pressure is measured at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months to compare pressure changes and record safety events. Enrollment requires an anatomically open angle (Shaffer grade ≥3) and cataract suitable for phacoemulsification.

Who should consider this trial

Good fit: Adults aged 18 or older with open-angle glaucoma and a cataract suitable for phacoemulsification who have an anatomically open angle (Shaffer grade ≥3) and can attend follow-up visits are eligible.

Not a fit: Patients with angle-closure, pigmentary or pseudo-exfoliative glaucoma, traumatic/uveitic/neovascular glaucoma, or other angle abnormalities that prevent correct stent placement are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, adding the iStent during cataract surgery could lower intraocular pressure and reduce the need for glaucoma medications after surgery.

How similar studies have performed: Previous studies of iStent implanted at the time of cataract surgery have shown modest reductions in intraocular pressure and use of glaucoma medications, so this approach has prior supportive evidence.

Eligibility criteria

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

Where this trial is running

Hangzhou

• Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University — Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: Kaijun wang, MD

Conditions Glaucoma