An interventional study of Selective retina therapy SPECTRALIS CENTAURUS device in Retinal Diseases, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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.
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.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
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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
Safety SPECTRALIS CENTAURUS - AEs
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
Time frame: 26 weeks
Safety SPECTRALIS CENTAURUS - DDs
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.
Time frame: At treatment (baseline)
Evaluation of OCT for SRT dosimetry
During treatment, OCT M-scans are recorded collinear to the treatment laser application. Post-treatment, all lesions are examined by fluorescein angiography (FA) for RPE cell damage. In addition, the OCT-M scan data is examined for fringe washouts (signal washouts) that occur with RPE cell damage. An analysis of these data (RPE cell damage vs. OCT fringe washouts) will reveal whether OCT is suitable for real-time dosimetry of SRT.
Time frame: At treatment (baseline)
Progression of AMD after laser treatment according to best-corrected visual acuity (BCVA)
Course of disease monitoring on AMD and confluent soft drusen with BCVA: Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart (consisting of rows of letters) / LogMAR chart (Logarithm of the Minimum Angle of Resolution), after appropriate refraction. Visual acuity represents the basic and most clinically relevant functional test to evaluate of central visual acuity.
Time frame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Progression of AMD after laser treatment according to OCT imaging
Course of disease monitoring on intermediary AMD and confluent soft drusen with OCT: OCT provides non-invasive morphological assessment of the retinal layers including the RPE and the choroid. It is a commonly used objective method during clinical assessment. OCT allows to identify structural changes such as Bruch's membrane ruptures, choroidal neovascularizations (CNV) with exudative macular edema, photoreceptor damage and drusen evolution. A macular volume OCT scan centered at the fovea will be acquired routinely. Additionally, volume OCT scans across the laser area will be acquired. This allows, for example, that a change in retinal thickness (μm) can be observed in the short term as well as in the long term. No single endpoint is given for this examination. However, experience shows that CNV would be the most likely case which can be expected with this laser treatment.
Time frame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Progression of AMD after laser treatment according to FA imaging
Course of disease monitoring on intermediary AMD and confluent soft drusen with FA: Fluorescein is injected intravenously before serial fundus image are taken after excitation of the fluorescein dye. No single endpoint is given for this examination. However, experience shows that CNV and subtle laser scars would be the most likely cases which can be expected with this laser treatment.
Time frame: At treatment (baseline) and after 12 weeks
Progression of AMD after laser treatment according to color fundus photography (CFP)
Course of disease monitoring on intermediary AMD and confluent soft drusen with CFP: CFP will be used to document and monitor pigmentary changes of the fundus and potential formation of scars after laser application. Since it is difficult to quantify fundus image changes, the principal investigator as well as a safety committee will evaluate fundus changes on an individual basis, taking into account the location and laser parameters used in the participant.
Time frame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Plan to share: No
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Insel Gruppe AG, University Hospital Bern