Open Label Early Feasibility Study Evaluating the Safety of the SPECTRALIS CENTAURUS Device for Dosimetry of Selective Retina Therapy With Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety SPECTRALIS CENTAURUS - AEs
研究概览
简要总结
The objective of this clinical trial is to evaluate the safety of the SPECTRALIS CENTAURUS device (HuCE-optoLab, BFH TI, Biel, CH) in a clinical setting on patients with retinal diseases.
详细描述
Optical microsurgery of the retinal pigment epithelium (RPE) requires reliable real-time dosimetry to prevent unwanted overexposure of the neuroretina. The SPECTRALIS CENTAURUS device implements optical coherence tomography (OCT) to detect intentional elimination of RPE cells caused by a prototype laser for selective retina therapy (SRT).
Within this clinical trial the safety of the SPECTRALIS CENTAURUS device and its ability to detect RPE cell damage towards selective real-time laser microsurgery will be evaluated.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent
- •For Stage 1, any patient aged >18 years with the need for conventional laser retina ablation
- •For Stage 2, will be restricted to people aged 50 to <95 years with lesion characteristics that meet the criteria for intermediate AMD
排除标准
- •Presence of reticular pseudodrusen
- •Any manifestation of late-stage AMD
- •Known hypersensitivity or allergy to fluorescein or uncontrolled hypertension
- •Concomitant systemic corticosteroid treatment for continuous period longer than 2 weeks
- •History of any vitreous haemorrhage within 4 weeks prior to screening or current haemorrhage in the study eye
- •Inability to obtain fundus photographs or fluorescein angiogram of sufficient quality
- •Photosensitive epilepsy
- •Insufficient retinal pigmentation (albinism)
- •Corneal opacity / lens opacity
- •Women of child-bearing potential
- •Contralateral eye is at an advanced stage of disease and has poor visual acuity
- •Inability to follow the procedures of the study
- •Participation in another study with investigational drug within the 30 days preceding and during the present study - Inability or lack of willingness to commit to return for all clinical visits and complete all study-related procedures
结局指标
主要结局
Safety SPECTRALIS CENTAURUS - AEs
时间窗: 26 weeks
The primary objective of this study is to assess the safety of the SPECTRALIS CENTAURUS device in clinical use by the evaluation of any adverse events (AEs) that may be related to the study device or the study intervention, including device deficiencies (DDs) The following potential AEs are evaluated throughout the study regarding the laser treatment: * Decrease in visual acuity * Choroidal neovascularization at treatment location (laser lesion) * Transient increased edema / decreased vision * Development or worsening of macular edema * Bruch's membrane rupture * Retinal and choroidal haemorrhage * Inadvertent foveal burns
Safety SPECTRALIS CENTAURUS - DDs
时间窗: At treatment (baseline)
In addition to the AEs, the following potential device deficiencies (DDs) can be listed in relation to the treatment and the SPECTRALIS CENTAURUS device: * Unintentional laser delivery * Unintentional OCT (M-scan) failure during the treatment * Unintentional scanning laser ophthalmoscope (SLO) failure during the treatment * Unintentional treatment software failure during the treatment * Unintentional treatment laser failure during the treatment * Basic system failure during the treatment Beside the DDs mentioned above, additional sub-criteria are assessed by default in advance to the treatment visit according to an acceptance test protocol (ATP). The ATP establishes the acceptance test framework for the SPECTRALIS CENTAURUS and describes the scope of the work performed and the approach taken to validate that the system performs as required. An acceptance test is carried out on each day on which a patient is to be treated.
次要结局
- Progression of AMD after laser treatment according to FA imaging(At treatment (baseline) and after 12 weeks)
- Progression of AMD after laser treatment according to color fundus photography (CFP)(At treatment (baseline) and after 1, 4, 12 and 26 weeks)
- Progression of AMD after laser treatment according to best-corrected visual acuity (BCVA)(At treatment (baseline) and after 1, 4, 12 and 26 weeks)
- Evaluation of OCT for SRT dosimetry(At treatment (baseline))
- Progression of AMD after laser treatment according to OCT imaging(At treatment (baseline) and after 1, 4, 12 and 26 weeks)