A Non-interventional, Extension Study on the Long-term Maintenance of Safety and Performance of the REVISYON SDS 100 Medical Device in Subjects With Mild-to-moderate Cataract
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- A summary of adverse events
研究概览
简要总结
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
详细描述
This study is an ancillary study to the EB-CE-01 clinical investigation. No treatment or any study-specific intervention is foreseen for the study subcohort. This study is designed to evaluate the maintenance of safety and efficacy an average 20 months following the end of treatment of mild-to-moderate senile cataract with the medical device in the EB-CE-01 clinical investigation in the Romanian subcohort of subjects. Due to the long enrolment gap and different treatment intervals, the tracking of subjects provided a significant difference in the intervals since treatment completion among subjects.
Therefore, the study approach involves a single additional visit for subjects who initiated treatment, during which supplementary data will be collected from standard-of-care ophthalmological assessments.
In the initial EB-CE-01 study, treatment with the non-invasive medical device REVISYON SDS 100 was administered between April 2023 and December 2024 to 92 patients, all of whom were included in both the Full Analysis Set and the Safety Set. Best corrected visual acuity (BCVA) was assessed at 7 (±1) days, 28 (±4) days, and 84 (±10) days following the final treatment session (known as Visit 9). Treatment efficacy was evaluated at 7 (±1) days only, corresponding to one-week post-treatment.
In this extension study, prospective data will be collected to assess the incidence of any safety events and to evaluate the maintenance of best-corrected visual acuity (BCVA), cataract severity grade, and visual functioning at an additional follow-up visit. The following timepoints from the parent study will be used as reference: EB-CE-01 V0 (pre-treatment), EB-CE-01 V1-V9 (treatment visits), and EB-CE-01 V12 (last efficacy visit), which will serve as the baseline for the current extension study.
The main objective of the study is capturing any new clinically significant findings that meet the definition of an AE in accordance with EU MDR 2017/745 and ISO 14155:2020, as to generate robust safety findings in the pre-market stage.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have initiated the EB-CE-01 study treatment phase in Romania
- •Availability of complete retrospective data from the EB-CE-01 study- specifically from visit 12 assessment- including binocular BCVA, binocular LOCS III assessments, binocular slit-lamp assessment, and baseline assignment of the study eye.
- •Be able and willing to follow instructions
- •Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study. Note: Subjects who underwent cataract surgery in either eye will be allowed to participate
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 involved in other clinical investigation that may compromise the results of the study.
- •Subjects developing mental illnesses that can influence their participation in the study (cognitive impairment, psychiatric condition, or neurological disorder).
- •Any health condition which could interfere with the subject's ability to comply with the study.
结局指标
主要结局
A summary of adverse events
时间窗: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
A summary of adverse events collected over an average of 20 months following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation. The types of adverse events to be collected (AEs, SADEs, USADEs, AESIs, and SAEs) will be classified by type, severity, outcome, seriousness and causality).
次要结局
- The mean change from Baseline post-treatment in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale(An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),)
- Preservation of the cataract severity grade, assessed using LOCS III grading scale for nuclear domain beyond 3 months(An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),)
- Subjective assessment of Visual function and Quality-of-life will be defined by the Visual Function Index-14 (VF-14) questionnaire data collected an average 20 months following the end of treatment with the medical device initiated in the EB-CE-01 study(An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),)