Condition or disease | Intervention/treatment | Phase |
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Retinal Diseases | Device: Selective retina therapy SPECTRALIS CENTAURUS device | Early Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Label Early Feasibility Study Evaluating the Safety of the SPECTRALIS CENTAURUS Device for Dosimetry of Selective Retina Therapy With Optical Coherence Tomography |
Estimated Study Start Date : | September 2021 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2023 |
Arm | Intervention/treatment |
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Experimental: 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. |
Device: Selective retina therapy SPECTRALIS CENTAURUS device
Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device
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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:
In addition to the AEs, the following potential device deficiencies (DDs) can be listed in relation to the treatment and the SPECTRALIS CENTAURUS device:
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.
Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sebastian Wolf, MD PhD | +41 (0)31 632 85 03 | sebastian.wolf@insel.ch | |
Contact: Chantal Dysli, MD PhD | +41 (0)31 632 25 01 | chantal.dysli@insel.ch |
Switzerland | |
University Hospital Inselspital | Recruiting |
Bern, Switzerland, 3010 | |
Contact: Chantal Dysli, PhD Dr. med. |
Principal Investigator: | Chantal Dysli, MD PhD | University of Bern |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 26, 2021 | ||||||||
First Posted Date ICMJE | July 20, 2021 | ||||||||
Last Update Posted Date | September 16, 2021 | ||||||||
Estimated Study Start Date ICMJE | September 2021 | ||||||||
Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Evaluating the Safety of the SPECTRALIS CENTAURUS Device | ||||||||
Official Title ICMJE | Open Label Early Feasibility Study Evaluating the Safety of the SPECTRALIS CENTAURUS Device for Dosimetry of Selective Retina Therapy With Optical Coherence Tomography | ||||||||
Brief 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. | ||||||||
Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Early Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Retinal Diseases | ||||||||
Intervention ICMJE | Device: Selective retina therapy SPECTRALIS CENTAURUS device
Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device
|
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Study Arms ICMJE | Experimental: 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. Intervention: Device: Selective retina therapy SPECTRALIS CENTAURUS device
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
30 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2023 | ||||||||
Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 95 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Switzerland | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04968756 | ||||||||
Other Study ID Numbers ICMJE | CENTAURUS | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University Hospital Inselspital, Berne | ||||||||
Study Sponsor ICMJE | University Hospital Inselspital, Berne | ||||||||
Collaborators ICMJE | Bern University of Applied Sciences | ||||||||
Investigators ICMJE |
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PRS Account | University Hospital Inselspital, Berne | ||||||||
Verification Date | September 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |