Abstract
Purpose :
Ophthafutur® safelight is a single-use, hand-held, sterile ophthalmodiaphanoscope. This study was established to evaluate the safety and efficacy of ophthafutur® safelight (CE marked on 2021-04-16) for the transscleral illumination during vitreoretinal surgeries.
Methods :
This Post Market Clinical Follow-Up study for the class Is medical device was registered prospectively (DRKS00025483). The study programm started on 2022-03-04. 43 participants were included. Investigated diseases were retinal detachment, proliferative diabetic retinopathy, epiretinal membrane and vitreous haemorrhage. Patient management comprises six visits: the initial screening, the surgical intervention, and postoperative follow-up visits on 1 to 3 days as well as at 4, 12, and 24 weeks. The primary endpoint was defined as illuminability of more than 50% of the retinal periphery.
Results :
With date of 05-Dec-2023, updated interim results are available: ophthafutur® safelight was applied successfully to 31 participants, including 27 participants with completed follow-up; the remaining 4 patients will complete their follow-up until March 2024. Up to now, during the use of the device and the observation period of the eyes, no toxic side effects was observed. The following benefits were reported in the postoperative questionnaires: 1) good illumination of the working area in the periphery 2) fewer reflections as advantage over fibre optics, especially during fluid-air exchange 3) The indentation significantly reduces the energy used by the laser to fix the retina. 5) Any haemorrhaging of the choroid can be stopped quickly by denting the safelight. While a use of ophthafutur® safelight totally without an additional chandelier endoillumination was scored as impossible with the current operating microscope, the transscleral illumination using the ophthafutur® safelight device reduces the chandelier illumination from 80% to 10-15% during macula treatment.
Conclusions :
Currently, the illumination of the entire globe during the procedure requires a handheld vitrectomy light pipe or chandelier additional to ophthafutur® safelight, but the transscleral illumination reduces to intensity of the light pipe to at least10%. This could be improve with the market launch of digital operating microscope.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.