Preclinical Safety and Feasibility Study of Line-Field Confocal Optical Coherence Tomography for Ophthalmology Applications.

PURPOSE: The purpose of this study was to demonstrate the first use of a commercially available, CE-marked line-field confocal optical coherence tomography (LC-OCT) in ophthalmology and assess its safety and feasibility for ocular imaging in rabbits, focusing on phototoxicity and tissue integrity.

METHODS

Five 14-week-old New Zealand White rabbits underwent corneal imaging using the DeepLive device (DAMAE Medical, Paris, France), originally developed for dermatologic applications. Imaging sessions lasted 5 to 10 minutes per eye, using illumination at a center wavelength of 820 nm and a power of 13.2 mW. Safety was evaluated in silico according to International Electrotechnical Commission (IEC) 60825-1 standards and in vivo through clinical assessments including slit-lamp examination, retinal imaging, and intraocular pressure (IOP) measurements at baseline, immediately after imaging, and on days 7 and 14. Histological analysis was performed day 14.

RESULTS

LC-OCT provided high-resolution three-dimensional imaging of the cornea (1.2 × 0.5 × 0.5 mm) and two-dimensional views of corneal layers, conjunctiva, and the nictitating membrane, revealing cellular details. In silico analysis confirmed that laser exposure remained below IEC safety limits. In vivo evaluations showed no corneal opacity, neovascularization, inflammation, or retinal alterations at any time point. Lens transparency remained normal (Lens Opacities Classification System [LOCS] III grade = 0), and IOP showed no treatment-related differences (P = 0.6713). Histology confirmed preservation of corneal and retinal structures.

CONCLUSIONS

Ophthalmologic use of CE-marked LC-OCT demonstrated safe, effective imaging in rabbits without phototoxicity, supporting its potential for clinical ophthalmic applications.

TRANSLATIONAL RELEVANCE: These findings provide preclinical safety evidence supporting LC-OCT as a noninvasive, high-resolution imaging modality for future clinical ophthalmology applications.