Post-market, Prospective, Randomised, Controlled, Masked Clinical Investigation to Compare the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD (Ophthalmic Viscosurgical Device)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
Prospective, randomized, subject/evaluator-masked post market clinical study at up to 2 sites at Gemini eye clinic in Czech Republic. Randomization will be done by the eye surgeon. The purpose of this post market clinical trial is to compare the safety and efficacy of Ophtesis Bio 3% with a similar 3% sodium hyaluronate OVD in routine cataract surgery.
详细描述
The purpose of this clinical study is to evaluate the performance of the Ophtesis Bio 3%. The primary endpoint is the rate of intraocular pressure (IOP) spikes of 30 mmHG or greater at the 7-day postoperative visit. The secondary endpoint will be the rate of user acceptance evaluated using the surgeon questionnaire at the surgery day visit. Other key endpoints will include IOP and IOP change from baseline at the 7-day postoperative visit, rate of inflammation measured using Slip Lamp at the 7-day postoperative visit, and rates of serious and/or device-related adverse events. Number of Subjects/eyes: Up to 296 eyes will be enrolled to achieve approximately 148 operated eyes per group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract for which extraction and posterior intraocular lens (IOL) implantation have been planned for one or both eyes
- •Clear intraocular media, other than cataract
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Signed informed consent
排除标准
- •Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
- •Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- •Use of systemic or ocular medications that may affect IOP
- •Known steroid responder
- •Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve
- •Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
- •Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: 7 days
Rate of intraocular pressure (IOP) spikes of 30 mmHG or greater
Surgeon questionnaire
时间窗: first day
The rate of user acceptance ten questions that can be answered on a scale from 1 to 5, 1 means the worst, 5 the best
次要结局
- IOP change(first day)
- Biomicroscopic Slit-Lamp Exam(Pre-operative visit, 7 days)
- Serious and /or Device-Related Adverse Events(first day, 7 days)
- Dilated fundus exam(Pre-operative visit, after only if medically indicated)
研究者
Dr. Pavel Stodulka
Chief eye surgeon
Gemini Eye Clinic