Decellularized Human Sclera; an Optimized Biomaterial for Scleral Reconstruction

The sclera, a dense tissue that provides structural support to the eye, can be damaged by various factors, necessitating surgical repair. Decellularization techniques, which preserve the essential extracellular matrix (ECM) while removing cells, offer a promising solution. This study aimed to develop an optimized decellularization protocol for human sclera and evaluate its effectiveness using a rabbit model for scleral defects.

Twelve New Zealand white rabbits underwent lamellar sclerectomy. The right eye was grafted with human native sclera (HNS), while the left eye received human acellular sclera (HAS) patches prepared by methods A, B, and C. Method A used sodium dodecyl sulfate (SDS); Method B combined SDS with Triton X-100; and Method C used a mix of SDS, EDTA, Triton X-100, and trypsin. Outcomes were assessed through cell nucleus visualization, cytotoxicity tests, SDS residue checks, structural assessments, slit lamp evaluations, AS-OCT scans, and histopathological reviews.

All protocols successfully decellularized tissues, confirmed by DAPI staining. With 80% cell viability, cytotoxicity was minimal and SDS residues were safely reduced. Method C best preserved collagen structures and ECM integrity. Slit lamp tests showed distinctions between HNS and HAS patches for Methods A and B, while Method C had superior biodegradability. All rabbits displayed conjunctival congestion, more so with HNS patches. AS-OCT showed the thinnest grafts with Method C. By the study's end, all patches had effectively healed the defects. Despite evident inflammation, especially in HNS patches, inflammation levels across HAS patches remained consistent.

The decellularized human sclera emerges as an ideal material for reconstructing the sclera. The proposed decellularization processes efficiently retained ECM while eliminating cells, making them robust and safe choices for mending damaged scleral tissue. This optimized biomaterial holds the potential to improve surgical outcomes in scleral reconstruction procedures.