Evaluating the Safety of the SPECTRALIS CENTAURUS Device
NCT ID: NCT04968756
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-09-09
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment with the SPECTRALIS CENTAURUS device
In Stage 1, two laser pattern will be applied in areas of the retina that require ablative laser photocoagulation.
In Stage 2, a laser pattern will be applied along and on the outside of the arcades. Furthermore, a treatment pattern will be applied to an area temporal to the fovea affected by intermediary age-related macular degeneration (AMD) and confluent soft drusen.
Selective retina therapy SPECTRALIS CENTAURUS device
Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device
Interventions
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Selective retina therapy SPECTRALIS CENTAURUS device
Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
95 Years
ALL
No
Sponsors
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Bern University of Applied Sciences
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Chantal Dysli, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bern
Locations
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University Hospital Inselspital
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Chantal Dysli, PhD Dr. med.
Role: primary
Other Identifiers
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CENTAURUS
Identifier Type: -
Identifier Source: org_study_id
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