View abstract

This abstract is assigned to session AOB and FRO E-Posters

Title	Foldable capsular vitreous body implantation study
Abstract Nr.	3001

Purpose	Recently, some clinical trials were reported in which an inflatable balloon-like device was introduced into the vitreous cavity and inflated with silicone oil after its insertion. The device is named “Foldable Capsular Vitreous Body” (FCVB) and is used with patients requiring a permanent silicone oil tamponade to avoid phtysis, but who are suffering from silicone oil emulsification. This study evaluates the clinical usefulness of the FCVB, but for a different racial type than the existing (Asians-only) studies. The FCVB was inserted in two Caucasian patients with permanent vision loss after retinal detachment, whereby a permanent use of silicone oil was required to maintain eye pressure.
Methods	Investigator-initiated, unblended, single-arm, mono-center, prospective, interventional case series phase IV trial (post-marketing, on-label use). Two patients were included and a 3-year follow-up is provided.
Results	Preliminary results after 4-month follow-up show a stable visual acuity for both patients and good toleration of the FCVB. Both patients also report an increased level of comfort since the implantation of the FCVB. One patient presents an increased IOP from 3mmHg (pre-op) to 9 mmHg (post-op), the other has a variable post-op IOP ranging between 1 and 9 mmHg, with normal digital eye pressure. No severe adverse events were yet reported, except for a mild discomfort for one patient which improved after increasing the frequency of corticoid eye drops.
Conclusion	These interim results indicate that the silicone oil-filled FCVB can be effective and safe as a vitreous substitute.
Conflict of interest	No

Authors 1

Last name	BEVERS
Initials	C
Department	U.Z. Leuven
City	Leuven

Authors 2

Last name	STALMANS
Initials	P
Department	U.Z. Leuven
City	Leuven