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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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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