H35.3
Conditions
Interventions
Group 1: Data from patients who participated in one of the following prospective studies will be analyzed:
TRAMP study (Az 2025-519) and MacuTherm study (DRKS00031781). The studies were conducted usin
Sponsors
Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Data sets from patients are included who: • participated in the MacuTherm study (DRKS00031781) or the TRAMP study (Az 2025-519), • were treated with the Navilas laser system under standardized titration methodology as part of these studies, • have qualitatively usable imaging data (e.g. color image, IR, FA, OCT) at at least two defined time points (e.g. after titration and after 4 weeks), • have agreed to the further use of their data in accordance with the original declaration of consent.
Exclusion criteria
Exclusion criteria: The following data sets are excluded from the analysis: • incomplete or poor quality imaging data, • lack of consent for further use of the data in accordance with the original consent, • significant deviation from the titration methodology used in the original study, • presence of ophthalmologic comorbidities that significantly impair a reliable assessment of the titration areas, • loss of data or lack of assignability of the data sets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comparison of the diagnostic sensitivity of the imaging modalities (color fundus imaging (CFI), blue autofluorescence (BAF), scanning laser ophthalmoscopy (SLO)-infrared (IR) imaging, optical coherence tomography (OCT), fluorescence angiography (FAG)) for detecting visible threshold lesions within two hours after laser titration. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Sensitivity of imaging modalities: is the order of imaging modalities of color fundus imaging (CFI), blue light autofluorescence (BAF), scanner laser ophthalmoscope infrared imaging (SLO-IR), optical coherence tomography (OCT), and fluorescein angiography (FAG) in terms of sensitivity with regards to visible thresholds after laser titration measured one month after laser titration • Tissue healing: Lesion thresholds move toward higher threshold 1 month after titration: meaning that lesions that are initially visible within two hours after titration may no longer be detectable after 1 month with the different imaging modalities CFI, BAF, SLO-IR, and/or OCT indicating partial or complete tissue healing below the threshold for permanent damage. Analysis will be conducted also with data measured within two hours after laser titration. • Probability of lesion visibility: Confirmation by BAF, SLO-IR, and/or OCT that it is safe to treat with 50% CFI-Factor: meaning treatment at 50% of the lesion visibility threshold identified by color fundus imaging (CFI) measured within two hours after later titration does not result in detectable permanent lesions across imaging modalities, indicating a safety margin for subthreshold laser application. Analysis will be conducted also with data measured one month after laser titration. • MSP vs CW: There is no statistically significant difference for threshold of lesions between microsecond-pulsed (MSP) and continuous wave (CW) laser modes when the delivered energy or average power is equivalent measured within two hours and one month after laser titration. Analysis will be conducted with data measured within two hours and one month after laser titration. • Parameters: Identification of parameters influencing the prediction of energy for individual threshold: meaning how does the threshold correlate to those parameters. Analysis will be conducted with data measured within two hours and one month after laser titration. | — |
Countries
Germany
Contacts
Public ContactYoko Miura
Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Outcome results
None listed