Functional evaluation of a novel vitreous substitute using polyethylene glycol sols injected into a foldable capsular vitreous body

Chen, Han; Feng, Songfu; Liu, Yaqin; Huang, Zhen; Zhou, Lian; Lu, Xiaoyan; Gao, Qianying

doi:10.1002/jbm.a.34560

Cited by 23 publications

(23 citation statements)

References 30 publications

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“…Since 2008, there have been at least 20 publications on the FCVB, ranging from original design and in vitro mechanical testing to animal testing and human clinical trials. [124][125][126][127][128][129][130][131][132][133][134][135][136][137][138][139][140][141][142][143] While radically different from the natural vitreous humor as well as other hydrogel vitreous substitute designs, the FCVB has been shown to be a safe and effective vitreous substitute in humans over a 1-and 3-year observation period. With clinical trials currently underway in China, the FCVB is arguably closest to routine clinical use in humans compared to other experimental hydrogel vitreous substitutes.…”

Section: The Strive For Improved Vitreous Substitutes and Intraocularmentioning

confidence: 99%

Macro- and Microscale Properties of the Vitreous Humor to Inform Substitute Design and Intravitreal Biotransport

Tram

Maxwell

Swindle-Reilly

2020

Current Eye Research

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Research on the vitreous humor and development of hydrogel vitreous substitutes have gained a rapid increase in interest within the past two decades. However, the properties of the vitreous humor and vitreous substitutes have yet to be consolidated. In this paper, the mechanical properties of the vitreous humor and hydrogel vitreous substitutes were systematically reviewed. The number of publications on the vitreous humor and vitreous substitutes over the years, as well as their respective testing conditions and testing techniques were analyzed. The mechanical properties of the human vitreous were found to be most similar to the vitreous of pigs and rabbits. The storage and loss moduli of the hydrogel vitreous substitutes developed were found to be orders of magnitude higher in comparison to the native human vitreous. However, the reported modulus for human vitreous, which was most commonly tested in vitro, has been hypothesized to be different in vivo. Future studies should focus on testing the mechanical properties of the vitreous in situ or in vivo. In addition to its mechanical properties, the vitreous humor has other biotransport mechanisms and biochemical functions that establish a redox balance and maintain an oxygen gradient inside the vitreous chamber to protect intraocular tissues from oxidative damage. Biomimetic hydrogel vitreous substitutes have the potential to provide ophthalmologists with additional avenues for treating and controlling vitreoretinal diseases while preventing complications after vitrectomy. Due to the proximity and interconnectedness of the vitreous humor to other ocular tissues, particularly the lens and the retina, more interest has been placed on understanding the properties of the vitreous humor in recent years. A better understanding of the properties of the vitreous humor will aid in improving the design of biomimetic vitreous substitutes and enhancing intravitreal biotransport.

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Section: The Strive For Improved Vitreous Substitutes and Intraocularmentioning

confidence: 99%

Macro- and Microscale Properties of the Vitreous Humor to Inform Substitute Design and Intravitreal Biotransport

Tram

Maxwell

Swindle-Reilly

2020

Current Eye Research

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“…FCVB have been approved in vitro and animal experiments [21][22][23]. Nevertheless, the clinical safety and efficacy of FCVB have not been verified yet, and previous associated clinical studies were not enough [18,19,24,25].…”

Section: Introductionmentioning

confidence: 99%

Study on the effectiveness and safety of Foldable Capsular Vitreous Body implantation

Zhang

Tian²,

Zhang³

et al. 2019

BMC Ophthalmol

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Background: Foldable capsular vitreous body (FCVB) was designed to treat severe retinal detachment. The aim of this study was to evaluate the efficacy and safety of the implantation of foldable capsular vitreous body in 1-year follow-up. Methods: A retrospective analysis was conducted for 20 patients with severe ocular trauma or silicone oil (SO) dependent eyes underwent vitrectomy and FCVB implantation in a 1-year follow-up. All treated eyes were peformed clinical examinations involved the visual acuity (VA) examination, Goldmann applanation tonometer, noncontact specular microscopy, fundus photography, B-Scan examination and optical coherence tomography (OCT). The groups were compared with t-test and the McNemar-Bowker test. Results: In 1-year follow-up, 20 eyes were evaluated in the study. FCVB well supported the vitreous retina in all treated eyes, and 6 treated eyes achieved retinal reattachment 12 months after FCVB implantation. There were no significant differences in VA before and after FCVB implantation (P = 1.000). In addition, the postoperative IOP markedly elevated from the preoperative IOP of 12.90 ± 7.06 mmHg to 15.15 ± 3.36 mmHg (P = 0.000017). The intraocular pressure (IOP) of 10 eyes maintained at a normal level after surgeries. The other 10 eyes showed slightly lower IOP within the acceptable level. Though two patients developed keratopathy and ocular inflammation respectively, other treated eyes were symmetric with fellow eyes showing satisfactory appearance. Moreover, there was no SO emulsification or leakage happened in the observation. Conclusions: FCVB implantation was an effective and safe treatment in the eyes with severe retinal detachment.

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“…Due to the good retinal support provided by the FCVB, a study of the FCVB combined with a retinal prosthesis currently is in process. Results of FCVB combined with polyethylene glycol 30 and polyvinylalcohol hydrogel 31 have been reported. Based on this trial, a nine-center clinical trial (122 cases) is enrolling patients in China to further evaluate the efficacy and safety of the FCVB in human eyes.…”

Section: Discussionmentioning

confidence: 99%

Three-Year Efficacy and Safety of a Silicone Oil-Filled Foldable-Capsular-Vitreous-Body in Three Cases of Severe Retinal Detachment

Lin

Wang

Jiang

et al. 2016

Trans. Vis. Sci. Tech.

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PurposeWe previously designed a novel foldable capsular vitreous body (FCVB) to treat severe retinal detachment and evaluated its performance in a 1-year follow up study. The purpose of this study was to determine the efficacy and safety of a silicone oil (SO)-filled FCVB in a 3-year follow-up.MethodsStandard three-port pars plana vitrectomy was performed, and the FCVB was triple folded and implanted in the vitreous cavity of three eyes. The SO then was injected into the capsule to support the retina. The eyes were examined using Goldmann applanation tonometry, fundus photography, optical coherence tomography (OCT), noncontact specular microscopy, and ultrasound biomicroscopy over a 3-year implantation period.ResultsAt the 3-year follow-up, retinal reattachment was achieved in all three cases, with steady intraocular pressure. The visual acuity showed slight fluctuations, and it was slightly increased compared to baseline. Optical coherence tomography revealed decreased retinal thickness and an altered retinal structure in the implanted eyes compared to the control eyes. No keratopathy, glaucoma, SO leakage, SO emulsification, or other apparent complications occurred during the observation period.ConclusionThe SO-filled FCVB was effective and safe as a vitreous substitute in three eyes over a 3-year observation period.Translational RelevanceSilicone oil emulsification is a severe complication after retinal detachment surgery. On the basis of animal experiments, we investigated a new strategy and product, the FCVB, to overcome this complication. In this pilot study, FCVB limited SO emulsification and migration. This study could lay the foundation for a further multicenter clinical trial.

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Functional evaluation of a novel vitreous substitute using polyethylene glycol sols injected into a foldable capsular vitreous body

Cited by 23 publications

References 30 publications

Macro- and Microscale Properties of the Vitreous Humor to Inform Substitute Design and Intravitreal Biotransport

Macro- and Microscale Properties of the Vitreous Humor to Inform Substitute Design and Intravitreal Biotransport

Study on the effectiveness and safety of Foldable Capsular Vitreous Body implantation

Three-Year Efficacy and Safety of a Silicone Oil-Filled Foldable-Capsular-Vitreous-Body in Three Cases of Severe Retinal Detachment

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