A Clinical Investigation of MINIVISC® PLUS 14 mg/ml Fermented Ophthalmic Viscosurgical Device (OVD-F), Used for Cataract Surgery and Implantation of Intraocular Lenses, Glaucoma Surgery, Anterior Segment Surgery and Corneal Transplantation (CGAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 10
- 主要终点
- Primary efficacy endpoint is the postoperative intraocular pressure (IOP)
研究概览
简要总结
A clinical investigation to confirm the clinical safety and performance of OVD-F device MINIVISC® PLUS 1.4 % for cataract surgery and implantation of intraocular lenses, glaucoma surgery, anterior segment surgery and corneal transplantation.
详细描述
The investigation will include two phases, Phase A and Phase B. The duration of the patient follow-up in Phase A is 90 days, in Phase B - 7 days, alternatively 30 days, depending on intraocular pressure, during which the safety and performance of the IMD will be assessed. AEs will be followed up until resolution or the follow-up assessment, whichever comes first, or according to the judgement of the PI or authorized designee.
In Phase A, eligible subjects will undergo surgery on one or both eyes. In case of both eye surgery, subjects will receive the IMD (MINIVISC®PLUS 14 mg/ml) in one eye and the control OVD (Healon GV® PRO 18 mg/ml OVD) in the other eye. OVDs will be randomly assigned by investigator to each eye to reach an as even as possible distribution of the IMD and comparator. In case of one eye surgery, MINIVISC® PLUS 14 mg/ml OR Healon GV® PRO 18 mg/ml will be randomly assigned to the eye.
Healon GV® PRO 18 mg/ml OVD is a legally marketed alternative with similar indications for use and similar properties as the MINIVISC®PLUS 14 mg/ml OVD.
In the Phase B, eligible subjects will undergo surgery on one eye. The subjects will receive the IMD (MINIVISC®PLUS 14 mg/ml OVD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, >18 years, in need of ophthalmic surgery for:
- •Glaucoma surgery
- •Anterior segment trauma or diseases
- •Damaged or diseased cornea
- •Able and willing to give informed consent for participation in the investigation.
- •For the participation in Phase A of the study, patients that need surgery on one or both eyes will be included. For the participation in Phase B of the study, patients that need surgery on one or both eyes will be included but only one eye can be included in the clinical investigation.
排除标准
- •Pregnant or lactating females.
- •Any previous hypersensitivity reaction to any constituent of the IMD.
- •Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial.
- •Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject.
- •Ocular hypertension of ≥22 mmHg, after 3 repeated measurements pre-surgery.
- •An endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively, based on the average of the three cell counts as taken by the Specular Microscope (only in Phase A).
- •Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator, including but not exclusive to diagnosis of wide-angle glaucoma, severe myopia, uveitis, and physical traits such as a small pupil, an extremely shallow anterior chamber, or a compromised endothelial cell function.
- •Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.
结局指标
主要结局
Primary efficacy endpoint is the postoperative intraocular pressure (IOP)
时间窗: 7 days
The primary endpoint is the postoperative intraocular pressure (IOP). A patient is defined as a failure if the IOP ≥ 30 mmHg within 7 days post-surgery (Data from Phase A and Phase B pooled, IMD only).
次要结局
- Secondary endpoint is the Postoperative inflammation, as measured by slit-lamp bio-microscopy, and graded using a standard grading system, such as The Standardization of Uveitis Nomenclature (SUN) Working group(+2hours, 7, 30 and 90 days,)
- Secondary endpoint is the central corneal endothelial cell density (cells/mm2), as measured by Specular Microscope images.(90 days)
- Secondary endpoint Principal investigator evaluation of adverse events during surgery, and at all follow-up visits.(Assessed during the whole study, in Phase A up to 90 (+/-14d) days, and in Phase B up to 30 (+/- 7d) days.)
- Secondary endpoint is Investigator/surgeon evaluation of IMD performance through ratings of a number of performance related criteria(Assessed by surgeon after surgery +2h)