Purpose: We previously invented a novel foldable capsular vitreous body (FCVB) in the treatment of severe retinal detachment. The purpose of this study was to determine its hydrolytic stability in vitro and further evaluate its efficacy and safety in human eyes.
Methods: The hydrolytic stability test proceeded according to State Food and Drug Administration guidelines about intraocular lenses of the ophthalmic implants. A standard three-port pars plana vitrectomy was performed, and FCVB was triple folded and sent into the vitreous cavity of three eyes; then silicone oil was injected into the capsule to support the retina. The treated eyes were examined using Goldmann applanation tonometry, fundus photography, optical coherence tomography, noncontact specular microscopy, and ultrasound biomicroscopy during a 12-month follow-up appointment.
Results: The mass of FCVB with silicone oil after 60-day accelerating aging temperature was equal to that at baseline. The FCVB can easily be implanted into the vitreous cavity through a 3-mm incision. The visual acuity and intraocular pressure after FCVB implantation show a slight elevation compared with those of preoperative eyes. The fundus and optical coherence tomography showed that the FCVB was well distributed in the vitreous cavity and evenly supported the retina. Retinal reattachment was found in 3 eyes at the 12-month examination. There was no statistically significant decrease in the density of corneal endothelial cells from baseline to 12 months after FCVB implantation. Ultrasound biomicroscopy showed that the FCVB smoothly contacted but not crushed the ciliary body.
Conclusion: Silicone oil-filled FCVB was shown to be effective and safe in 3 eyes as a vitreous substitute over a 12-month observation time.