Efficacy and Safety of iStent in Reducing Intraocular Pressure in Open-angle Glaucoma
Recruiting · NCT07354009 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
PHACO+PC-IOLPHACO+PC-IOL+iStent
What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University - Hangzhou, China