Evaluation of the flexibility, efficacy, and safety of a foldable capsular vitreous body in the treatment of severe retinal detachment.

PURPOSE: To determine the flexibility, efficacy, and safety of a novel foldable capsular vitreous body (FCVB) in the treatment of severe retinal detachment in human eyes.

METHODS

The study involved 11 patients with 11 severe retinal detachments. A standard three-port pars plana vitrectomy was performed, and the FCVB was triple-folded and implanted into the vitreous cavity. Balanced salt solution was then injected into the capsule of the FCVB to support the retina. The treated eyes were examined by ophthalmoscopy, fundus photography, and tonometry during a 3-month implantation period. B-scan ultrasonography, optical coherence tomography (OCT), ultrasound biomicroscopy (UBM), and electroretinogram (ERG) were also performed. The FCVB was removed and examined in the laboratory at the end of the 3-month treatment time.

RESULTS

The FCVB was easily implanted into the vitreous cavity through a 3-mm incision and was easily removed through a 2-mm scleral incision. Retinal reattachment was found in 8 (73%) of 11 eyes at the end of the 3-month treatment time. The fundus, B-scan, and OCT showed that the FCVB was well distributed in the vitreous cavity and evenly supported the retina. IOP and visual acuity in the FCVB-treated eyes did not show a significant difference when compared with the preoperative measurements. UBM showed that the FCVB smoothly contacted but did not crush the ciliary body. Laboratory examinations showed no significant inflammatory cells in the balanced salt solution, no decrease in spectral transmittance, and no blocking of tiny apertures from the FCVB after a 3-month implantation period.

CONCLUSIONS

The FCVB was shown to be flexible, effective, and safe as a vitreous substitute over a 3-month implantation time. (ClinicalTrials.gov number, NCT00910702.).