Implantation Protocol of the Foldable Capsular Vitreous Body for Complex Vitreoretinal Surgery

Summary

The Foldable Capsular Vitreous Body (FCVB) is an intraocular implant that encapsulates silicone oil within a flexible capsule to reduce silicone oil-related complications. This protocol describes the surgical implantation of the FCVB via scleral incision for the treatment of complex retinal detachment and ocular trauma.

Abstract

The Foldable Capsular Vitreous Body (FCVB) is an implantable vitreous substitute designed to provide internal tamponade in eyes with complex vitreoretinal conditions. This protocol describes a standardized surgical procedure for FCVB implantation via a scleral incision, followed by silicone oil injection. The protocol outlines key preoperative considerations, including patient selection and device sizing, followed by detailed intraoperative steps, including capsule folding, insertion into the vitreous cavity, controlled silicone oil injection, device positioning, and scleral fixation. Postoperative management strategies, including patient positioning, medication regimens, and follow-up evaluation, are also described to support procedural reproducibility.

This protocol is intended for adult patients aged 18 to 65 years, with no sex-related restrictions. Eligible subjects must have a best-corrected visual acuity of less than 0.05 in the treated eye, an ocular axial length ranging from 16 to 28 mm, and present with severe retinal detachment that cannot be effectively managed using currently available vitreous substitutes. Previous clinical studies have reported that FCVB implantation can reduce silicone oil–related complications, such as emulsification and secondary glaucoma, by physically isolating silicone oil from intraocular tissues. These reported outcomes provide the clinical rationale for the use of FCVB but are not generated by this protocol itself. By presenting a step-by-step surgical workflow and highlighting critical technical considerations, this protocol serves as an instructional guide for vitreoretinal surgeons seeking to perform FCVB implantation or adapt the technique to their own surgical settings.

Introduction

Retinal detachment remains a sight-threatening condition, particularly in eyes with severe ocular trauma, multiple recurrences, or prolonged dependence on intraocular tamponade. Silicone oil is widely used as a vitreous substitute in complex vitreoretinal surgery because it provides long-term internal support; however, direct contact between silicone oil and intraocular tissues has been associated with complications such as emulsification, corneal endothelial damage, secondary glaucoma, hypotony, and long-term silicone oil dependence¹. Despite their widespread clinical use, no currently available vitreous substitute fully meets the requirements....

Protocol

This protocol describes a standard surgical technique using an approved medical device and does not involve experimental interventions. Therefore, formal institutional ethics committee approval was not required. Written informed consent was obtained from all patients or their legal guardians prior to surgery, in accordance with the principles of the Declaration of Helsinki.

1. Preoperative preparation¹²

1. Select appropriate patients, including those with severe ocular trauma (e.g., perforating injury, choroidal rupture), recurrent retinal detachment, silicone oil-dependent eyes, endophthalm....

Results

To evaluate the clinical relevance of the proposed procedure, we reviewed previously published studies reporting postoperative complication rates following FCVB implantation and conventional silicone oil tamponade. The data are summarized and compared to highlight differences in safety profiles between the two approaches (Table 1).

Published studies consistently demonstrate that accurate FCVB folding and implantation (Figure 1) result in lower rat.......

Discussion

Within this manuscript, intraoperative and postoperative images demonstrate procedural checkpoints indicating correct execution of the protocol, such as complete capsule unfolding, correct orientation, and anatomical stabilization. In contrast, statements regarding safety, complication rates, and long-term outcomes are derived from previously published studies and should be interpreted as literature-supported expectations rather than outcomes demonstrated by this protocol.

The FCVB implantatio.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Anesthetic agent	As per institutional protocol		Local or general anesthesia Quantity: 1
Balanced saline solution (BSS) / sterile normal saline	—		30ml Quantity: 1
Caliper	—		Ophthalmic surgical caliper Quantity: 1
Foldable Capsular Vitreous Body (FCVB)	Guangzhou Vesber Biotechnology		Size determined preoperatively (AV-10P, AV-10PX, AV-12P, AV-13.5P, AV-15P, and AV-17P) Quantity: 2
Intraocular lens (IOL) implantation forceps	—		Ophthalmic Quantity: 1
Iris repositor	—		Ophthalmic type Quantity: 1
Lid speculum	—		Adult ophthalmic Quantity: 1
Lint-free sterile gloves			Quantity: 1
Microsurgical forceps (non-toothed)	—		Ophthalmic Quantity: 1
Microsurgical forceps (toothed)	—		Ophthalmic Quantity: 1
Microsurgical scissors (angled)	—		Ophthalmic Quantity: 1
Needle (25G) or 25G vitrectomy trocar needle	—		25-gauge Quantity: 1
Ophthalmic viscosurgical device (sodium hyaluronate)	Bausch + Lomb		1 mL Quantity: 1
Positioning hook	—		Ophthalmic Quantity: 1
Silicone oil	Bausch + Lomb		VRL600 Quantity: 1
Silicone oil	Fluoron (Germany)		Siluron 5000 Quantity: 1
sterile beaker	—		30 mL Quantity: 1
Sterile gauze pads	—		Quantity: 1
Sterile syringe	—		2 mL Quantity: 1
Sterile syringe	—		10 mL Quantity: 1
Suture, absorbable (Vicryl)	Ethicon		7-0 Quantity: 1
Suture, non-absorbable	—		10-0, Model 8065307901 Quantity: 1
Suture, non-absorbable	—		5-0
Suture, non-absorbable (US)	—		10-0 Quantity: 1