PER-041-20已完成未知
CLINICAL PILOT STUDY, IN A SINGLE CENTER, OF OPEN DESIGN TO EVALUATE PRELIMINARY EFFICACY AND SAFETY OF IMPLANTE PLANO MIRANDA (IPM) IN SUBJECTS WITH PRIMARY OPEN ANGLE GLAUCOMA WITH UNCONTROLLED INTRAOCULAR HYPERTENSION.
MM INSTRUMENTOS S.A.C.,0 个研究点目标入组 0 人开始时间: 2020年11月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
- •1. Sign and date an informed consent document in accordance with the GCP guidelines and local regulations approved by a Research Ethics Committee where all aspects of the protocol are explained.
- •2. The subject must be 18 years of age or older.
- •3. The subject must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is not controllable with the maximum tolerated medical treatment with ocular hypotensive drugs or who has failed in traditional glaucoma surgery or who is not considered a reasonable candidate for traditional surgery.
- •4. A documented IOP of the subject should be considered by the treating physician to be too high for their glaucoma status.
- •5. The subject must have, in the study eye, a BCVA between 20/50 and light perception, or not have light perception with pain greater than 03 on a scale of 00 to 10, where, 00 is no pain, 05 is moderate pain and 10 is very severe pain.
- •6. The subject should have a BCVA in the other eye better than that of the study eye.
- •7. The subject must be mentally competent and willing to give informed consent.
- •8. Subject must be willing to return for all study visits and evaluations for at least one (1) year after surgery.
排除标准
- •1. Subjects who have participated in the past three months, are participating, or plan to participate in a study with any investigational agent (drug or device).
- •2. Subjects with serious pulmonary or cardiovascular disorders, progressive stage cancer, chronic unstable diseases or acute diseases that may influence the evaluation of the study.
- •3. Pregnant women.
- •4. Subjects with a diagnosis of glaucoma other than open-angle glaucoma, including recent uveitic, active neovascular, or recent traumatic glaucoma.
- •5. Subjects with a clinically significant corneal condition, including corneal dystrophy.
- •6. Subjects with iridocorneal endothelial syndrome.
- •7. Subjects with an anterior chamber configuration that puts them at high risk for developing angle-closure glaucoma.
- •8. Subjects with any recent eye or periocular inflammation or infection in the past 30 days.
- •9. Subjects with a history of considerable keloid formation.
- •10. Subjects requiring ancillary procedures in the study eye at the time of implantation or during the first year of the study period.
- •11. Subjects with any known intolerance or hypersensitivity to topical anesthetics, mydriatics or device components.
- •12. Subjects who cannot discontinue their anticoagulant, antiplatelet, or NSAID therapy (including aspirin) for at least one (1) week prior to surgery.
- •13. Researchers, medical center staff directly affiliated with this study and their immediate relatives. An immediate family member is defined as a spouse, parent, child, or descendant, whether biological or legally adopted.
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