Evaluating the Safety of the SPECTRALIS CENTAURUS Device (NCT04968756) | Clinical Trial Compass
UnknownNot Applicable
Evaluating the Safety of the SPECTRALIS CENTAURUS Device
Switzerland30 participantsStarted 2021-09-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.