NCT04252716已完成不适用
Prospective, Randomized, Multi-centre, Observer-masked, Non-inferiority Comparison of Two Cohesive Viscoelastic Solutions: VISTHESIA v Provisc
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- IOP
研究概览
简要总结
To investigate that VISTHESIA 1.5 is non-inferior to Provisc with regards to elevation in IOP greater than or equal to 30 mm Hg 6 ± 2 hours post-operatively as per methodology set out in EN ISO 15798:2013 (Primary Endpoint) To compare the changes in endothelial cell count and incidences of intraocular inflammation between VISTHESIA and Provisc as per methodology set out in EN ISO 15798:2013
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any gender, 50 years of age or older at the time of study enrolment
- •undergoing age-related cataract removal (phacoemulsification) and IOL implantation in one eye only
- •Patient informed of the needs and visit schedule required of the Clinical Investigational Plan and who has given his/her written informed consent
- •Planned implantation of the IOL in the capsular bag
排除标准
- •Patients not able to / willing to give informed consent
- •Patients not able to comprehend and comply with study requirements
- •Patients scheduled for surgery to the fellow eye within 48 hrs preceding any scheduled study follow up. (Surgery date could be changed)
- •Patients not able to attend follow-up appointments for any reason
- •Patients with known hypersensitivity to anaesthetics of the amide type or hyaluronan
- •Patients with reduced corneal endothelium (e.g. Fuch's dystrophy)
- •Patients with epilepsy, impaired cardiac conduction, bradycardia, or impaired respiratory function
- •Patients being treated with tocainide for cardiac arrhythmia
- •Patients with impaired hepatic function, if the anaesthetic dose or site of application is likely to result in high blood levels
- •Mono-ophthalmic patients
- •Patients who have previously undergone cataract surgery in the contralateral eye
- •Patients with any psychosocial, or other chronic disease conditions that may affect the perception of bodily pain
- •VISTHESIA (topical and intracameral components) or ProVisc is not a suitable device for the patient for any reason
- •Patients with other pathology or condition presenting, according to the investigator opinion, a risk for the patient (to be documented in screen log)
- •Female patients who are menstruating, pregnant, breastfeeding or amenorrheic for less than 2 years at the time of surgery
- •Patients who may require the use of hyaluronidase as part of the study cataract procedure
- •Patients who may be regarded as being vulnerable (e.g. prisoners, residents of care or mental health institutions, trauma, war or disaster victims, dependent on the investigator etc.)
结局指标
主要结局
IOP
时间窗: 6-hours post-operatively
Frequency of incidence of Intraocular Pressure greater than or equal to 30 mm Hg
次要结局
未报告次要终点
研究者
研究点 (1)
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