Prospective, Multicenter, Non-comparative Clinical Investigation to Support Safety & Effectiveness of I.SPACE® Ophthalmic Viscosurgical Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- Mean percent change of Corneal Endothelium Cells (CEC) density
研究概览
简要总结
I.SPACE® is a hyaluronic acid injectable gel CE (European Conformity) marketed since 2010. It is indicated for use as a surgical aid in ophthalmic anterior segment surgery. The aim is to protect the corneal endothelium and maintains the intraocular space.The product should be instilled in the anterior chamber of the eye and adjusted according to the volume of the aqueous humour.
In this study, 80 patients aged from 18 to 84 years' old at inclusion, who have at least one eye with cataract (mild to moderate severity) based on subjective ophthalmic examination by the investigator, who have given his/her informed consent and meet all the eligibility criteria, will be enrolled.
Subjects will come to a total of 7 visits over a period of 3 months. Protection of corneal endothelium (Mean percent change of CEC density) after baseline injection will be assessed. Surgeon's satisfaction during cataract surgery, mean change in Intraocular Pressure (IOP), percentage of eyes with IOP spikes ≥ 30mm mmHg, corneal thickness, intraocular inflammation, Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and safety will be also assessed.
详细描述
PROMIR is a prospective, multicenter, non-comparative post-marketing study of a class IIb medical device (medical device regulatory classification IIb).
This uncontrolled open-label study investigates the efficacy and safety of I.SPACE® in corneal endothelium protection and intraocular space maintain.
The study duration is 3 months with a screening visit (V0) up to 14 days before injection, the baseline visit (injection of I.SPACE®), V1) and 5 follow-up visits after 6 hours, 24 hours, 7 days, 30 days and 90 days (V1' to V5). It is envisaged to enroll 80 patients with planned cataract surgery for at least 1 eye in France to obtain at least 68 evaluable patients, which will be monitored over 3 months after baseline injection of I.SPACE® .
The primary endpoint is defined as the mean percent change of CEC density at 3 months (90 days) post-operation (V5) from Baseline (V0). The effectiveness of I.SPACE® will be demonstrated if the CEC density loss is statistically non-superior to a pre-specified threshold of 10% (non-inferiority to -10%).
Surgeon's satisfaction after cataract surgery (questionnaire) will be evaluated at V1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged from 18 to 84 years' old at inclusion.
- •Having at least one eye with cataract (mild or moderate severity) based on subjective ophthalmic examination by the investigator.
- •Informed of the clinical investigation and having given freely and expressly his/her informed consent.
- •Affiliated to a health social security system.
- •Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before screening visit.
排除标准
- •In terms of population
- •Pregnant or breastfeeding women or planning a pregnancy during the clinical investigation.
- •Participating at the same time in another clinical investigation or is in an exclusion period of one.
- •Deprived of their freedom by administrative or legal decision or under guardianship.
- •Known hypersensitivity to one of the investigational medical device (IMD) ingredients.
- •One-eyed patients.
- •In terms of associated pathology
- •Pre-existing :
- •Glaucoma,
- •severe myopia,
- •diabetic retinopathy,
- •retinal vascular disease,
- •Acute ocular disease or external infection or internal infection or uveitis prior to surgery,
- •Known ocular disease/pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention (other than cataract surgery) during the course of the study.
- •Any causes of compromised aqueous humor outflow.
- •History of :
- •Intraocular surgery,
- •ocular trauma,
- •lens pseudoexfoliation capsular syndrome,
- •ocular hypertension > 21 mmHg without treatment
- •chronic or recurrent inflammatory eye disease or a congenital ocular anomaly such as Marfan's Syndrome
- •Endothelial cell density at baseline less than 2000 cells/mm2 or poor quality photograph of preoperative endothelial cells (all reasons including corneal abnormalities).
- •Any abnormalities that prevented reliable Goldmann applanation tonometry.
- •Eyes with Axial Length (AL) >25 mm or < 20 mm or eyes with small pupil diameter, pathologic miosis or pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils);
- •Relating to previous and ongoing treatments:
- •Patient currently treated with Tamsulosine and other alpha 1 antagonist or psychotics
结局指标
主要结局
Mean percent change of Corneal Endothelium Cells (CEC) density
时间窗: 3 months (90 days)
Mean percent change of CEC density at 3 months (90 days) post-operation from Baseline. The effectiveness of I.SPACE® will be demonstrated if the CEC density loss is statistically non-superior to a pre-specified threshold of 10% (non-inferiority to -10%).
次要结局
- Mean percent change of CEC density(30 days)
- Intraocular inflammation evaluation(6 hours, 24 hours, 7 days, 30 days and 90 days.)
- Intraocular space maintenance evaluation(Baseline (surgery))
- Surgeon's satisfaction evaluation(Baseline (surgery))
- Mean change in Intraocular Pressure (IOP)(6 hours, 24 hours, 7 days, 30 days and 90 days.)
- Percentage of eyes with IOP spikes ≥ 30 millimeter of mercury (mmHg)(6 hours, 24 hours, 7 days, 30 days and 90 days.)
- Corneal thickness evaluation(24 hours, 7 days and 90 days.)
- Mean Snellen monocular Uncorrected Distance Visual Acuities (UCDVA), Best Corrected Distance Visual Acuities (BCDVA) and ocular symptoms(24 hours, 7 days, 30 days and 90 days.)
- Report of adverse effects(90 days)