Efficacy and Safety of iStent in Reducing Intraocular Pressure in Open-angle Glaucoma

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура PHACO+PC-IOL+iStent
  PHACO+PC-IOL+iStent
• Процедура PHACO+PC-IOL
  PHACO+PC-IOL

Первичные конечные точки

• intraocular pressure [Срок оценки: Baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07354009 · 2025-1421

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗