Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 8
- 主要终点
- Cumulative IOP Spike Rate From Safety Endpoint
研究概览
简要总结
Prospective, multicenter, paired-eye, randomized, subject/evaluator-masked clinical investigation of the experimental EndoCoat OVD versus the control EndoCoat OVD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 22 years of age
- •Cataracts for which extraction and posterior chamber IOL implantation have been planned in both eyes
- •Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better
- •Clear intraocular media, other than cataract
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Signed informed consent and HIPAA authorization
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 clinical outcomes or increase risk to the subject
- •Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
- •Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study.
- •Prior, current, or anticipated use during the course of the 3-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
- •Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
- •Use of systemic or ocular medications that may affect vision or IOP
- •Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study, or in the opinion of the investigator, may confound the outcome(s) of the study
- •Poorly-controlled diabetes
- •Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.).
- •Known steroid responder
- •Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve
- •Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the average of the three cell counts as taken by the Konan Specular Microscope)
- •Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
- •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 60 days prior to preoperative visit in any other clinical trial
研究组 & 干预措施
Investigational Healon EndoCoat
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
干预措施: Investigational Healon Endocoat (Device)
Investigational Healon EndoCoat
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
干预措施: Control Healon EndoCoat (Device)
Control Healon EndoCoat
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
干预措施: Investigational Healon Endocoat (Device)
Control Healon EndoCoat
Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
干预措施: Control Healon EndoCoat (Device)
结局指标
主要结局
Cumulative IOP Spike Rate From Safety Endpoint
时间窗: 3-month postoperative
The cumulative IOP spike rate is the proportion of eyes that experienced at least one IOP spike within each arm during the 3-month postoperative period. The status of the cumulative IOP spike is either 'Yes, Spike' or 'No, Non-Spike,' and the results of the cumulative IOP spike rate are presented in percentage. For this outcome measure, subjects have been analyzed as per treated received, which gives investigational OVD of 131 participants and 131 eyes treated; and control OVD of 130 participants and 130 eyes treated.
ECC Percent Change From Effectiveness Endpoint
时间窗: 3-month postoperative
The success criterion for the primary effectiveness endpoint was met (modified ITT Population) as the investigational device (HEALON EndoCoat OVD) demonstrated non-inferiority to the control device (HEALON EndoCoat OVD) with respect to the difference in mean ECC percent change. For this outcome measure, subjects have been analyzed as per planned randomization schema, which gives investigational OVD of 130 participants and 130 eyes randomized; and control OVD of 131 participants and 131 eyes randomized.
次要结局
未报告次要终点