CTRI/2019/08/020913暂停1 期
PERFORMANCE AND SAFETY EVALUATION STUDY FOLLOWING MINIMAL INVASIVE MICRO SCLEROSTOMY PROCEDURE IN CASE OF PRIMARY OPEN ANGLE GLAUCOMA - MIMS
Appasamy Ocular Devices Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male or female ââ?°Â¥ 18 years
- •Primary open-angle Glaucoma, pseudoexfoliation Glaucoma or pigmentary Glaucoma in the study eye (EGS criteria)
- •Optic nerve appearance characteristic of Glaucoma in the study eye
- •Patient is treated with 0 to 5 hypotensive medications in the study eye
- •Unsatisfactory IOP ( >21 mmHg) at the screening visit in the study eye
- •If cataract is not present - Shaffer grade ââ?°Â¥ III in all four angle quadrants in the study eye
- •Subject is able and willing to attend all scheduled follow-up exams
- •Subject understands and signs the informed consent
排除标准
- •Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
- •Closed angle forms of Glaucoma in either eye unless scheduled for cataract surgery immediately prior to the MIMSÃ?® procedure or the study eye is pseudophakic with PCIOL.
- •Congenital or developmental Glaucoma in either eye
- •Other secondary Glaucoma (such as neovascular, uveitic, lens- induced, trauma-induced, or Glaucoma associated with increased episcleral venous pressure) in the study eye
- •Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye
- •Subject has history of penetrating keratoplasty (PKP)
- •Any previous surgery in the study eye (except for clear corneal cataract surgery) where the conjunctiva is not intact and elastic.
- •Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
- •Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemmââ?¬•s canal in the study eye.
- •Best-correctedvisualacuityworsethan20/40(Snellen equivalent) in the fellow eye
- •History of idiopathic or autoimmune uveitis in either eye
- •Severe trauma in study eye
- •active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil, need for Glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month period
- •Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eye
- •Prior vitreoretinal surgery in study eye
- •Clinically significant ocular inflammation or infection within 90 days prior to screening
- •Unable to discontinue use of blood thinners in accordance with surgeonââ?¬•s standard preoperative instructions
- •Uncontrolled systemic disease that in the opinion of the investigator would put the subjectââ?¬•s health at risk and/or prevent the subject from completing all study visits
- •Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit
- •Pregnant or lactating women
研究者
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