RECRUITINGINTERVENTIONAL
Efficacy and Safety of iStent in Reducing Intraocular 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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form and participate in the regular postoperative follow-up as required.
Who Should NOT Join This Trial:
- 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;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
PHACO+PC-IOL+iStent
PHACO+PC-IOL+iStent
PROCEDURE
PHACO+PC-IOL
PHACO+PC-IOL
Locations (1)
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, China