Study On The Performance And Safety Of The REVISYON SDS 100 Device On Visual Acuity In Subjects With Cataract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 20
- 主要终点
- Change in Visual Acuity
研究概览
简要总结
Single arm, unmasked study to evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract.
详细描述
This single arm, unmasked study will evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract.
Only one of the subject's eyes will be treated with the REVISYON SDS 100 Device during the study (blue light treatment beam: Visit 1: 15 minutes, Visits 2 - 9: 20 minutes). The Treatment period will last 19 days (+ 1 day), starting with the day of first treatment (Visit 1, day 1). During this period, subjects will be treated with the REVISYON SDS 100 investigational device three-times a week for 3 weeks (Visit 1 to Visit 9) up to a maximum of 20 days (or 2.9 weeks). The Treatment period will be followed by 84 days (± 10 days) of follow up, up to a maximum of 94 days (or 13.4 weeks).
The subject's eyes will be examined throughout the study to allow safety and performance to be monitored. The safety examinations includes standard ophthalmological tests.
Clinical assessments in the study will use traditional ophthalmic methods including LogMAR best corrected visual acuity (BCVA) for distance, and grading of cataracts using LOCS III.
In addition, spectral data (fluorescent emission) will be collected using the REVISYON SDS 100 Device to monitor the progress of the treatment, and to determine the suitability of these measurements for future clinical diagnoses.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator
- •Subject aged between 40 and 85 years of age (inclusive) at the time of consent
- •Best Corrected Visual Acuity (BCVA) of 0.3 LogMAR or worse due to cataract only
- •Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study
- •Subject who is judged suitable for the study after ophthalmic examination carried out by the Investigator
- •Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator - including being able to sit upright for at least 20 mins (duration of the treatment)
排除标准
- •Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalised by court or official order, or in a dependency relationship with sponsor, testing centre or investigator
- •Subject who had been clinically diagnosed with any eye diseases which may impact upon the treatment, or the subject's ability to be assessed after treatment
- •Subjects with intraocular lens (IOL) implant in either eye
- •Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period
- •Subject with shallow anterior chamber
- •Subject who have had a fluorescence angiogram or any use of fluorescein within the last 3 days
- •Subject presenting eye infection or eye damage in either eye
- •Any condition which could interfere with the subject's ability to comply with the study including participation in all study assessments and visits.
- •Subject who had undergone a treatment using photodynamic drugs within the last 30 days. (Including but not limited to methylene blue, toluidine blue, Visudyne®, Foscan, Photofrin or 5-aminolevulinic acid/ALA)
- •Subject diagnosed with any other health condition which, in the opinion of the Investigator, would pose a safety risk to the subject by participating in the study, or may interfere with or jeopardise the study evaluation, procedures or completion
- •Subject currently receiving treatment in another investigational study or has completed another investigational study within the last 30 days
- •Subject participated in the previous study with the REVISYON Device (EB-14-LAT)
- •Females who are pregnant or lactating
- •Females who are of childbearing potential (menses within the last 12 months) and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable contraceptive precautions may be included.
结局指标
主要结局
Change in Visual Acuity
时间窗: 4 weeks
Change in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale.
次要结局
- Change in Cataract Severity(4 weeks)
- Subjective satisfaction using Visual Function Index(4 weeks)