Top

Graefe's Archive for Clinical and Experimental Ophthalmology

Published in:

01-11-2016 | Retinal Disorders

Intraocular silicone implant to treat chronic ocular hypotony—preliminary feasibility data

Authors: Wesal Bayoudh, Markus Frentz, Dörthe Carstesen, Barbara Dittrich, Caroline Reismann, Norbert F. Schrage, Peter Walter, Andreas W. A. Weinberger

Published in: Graefe's Archive for Clinical and Experimental Ophthalmology | Issue 11/2016

Abstract

Purpose

Ocular hypotony secondary to proliferative vitreoretinopathy-related retinal detachment, trauma or inflammation is difficult to treat. Besides endotamponades such as silicone oil, vitreous implants such as iris diaphragms or balloons have been developed to stabilize the eye and to prevent phthisis of the globe. Vitreous implants tested thus far exhibit a seam at the attachment site of the hemispheres, or micropores. This manuscript reports the development of a seamless silicone balloon implant without micropores, which can be filled with silicone oil and surface-modified to improve its biocompatibility. Developed for intraocular placement in the management of chronic hypotony and phthisis prevention, it may also be suitable for tamponading retinal detachments.

Methods

Silicone was used as the basic structure for the fabrication of a seamless balloon-shaped intraocular implant, which was coated by employing a six-arm star-shaped (sP) macromer of a copolymer of 80 % ethylene oxide (EO) and 20 % propylene oxide (PO) with conjugated functional terminal isocyanate groups, NCO-sP(EO-stat-PO), with and without heparin. Three variants of implants, which differ in their surfaces, were manufactured: uncoated silicone, NCO-sP (EO-stat-PO) coated silicone and heparin-NCO-sP (EO-stat-PO) coated silicone implants. To exert a tamponade effect, the implant was filled with silicone oil and its properties were studied.

Results

Seamless thin balloon implants made of silicone, which are considered biocompatible and intrinsically resistant to biological attacks in vivo, could be fabricated in different sizes. The silicone oil-filled implant can mimic the mechanism of buoyant force and high surface tension of silicone oil, which is the only long-term vitreous substitute currently available. The silicone oil-filled implant can also mimic the natural vitreous body by occupying the entire posterior segment.

Conclusions

The intraocular silicone implant as an alternative long-term treatment of chronic ocular hypotony might offer a new option for clinical ophthalmological practice. In vivo studies need to be performed to collect more data on the implant’s long-term mechanical and optical properties, as well as long-term biocompatibility.

Jonas JB, Vossmerbaeumer U, Kamppeter BA (2004) Chronic prephthisical ocular hypotony treated by intravitreal triamcinolone acetonide. Acta Ophthalmol Scand 825:637CrossRef

De Smet MD, Gunning F, Feenstra R (2005) The surgical management of chronic hypotony due to uveitis. Eye 191:60–64CrossRef

Cadera W, Harding PW, Gonder JR, Hooper PL (1993) Management of severe hypotony with intravitreal injection of Healon. Can J Ophthalmol 28(5):236–237PubMed

Arevalo JF, Garcia RA, Fernandez CF (2004) Anterior segment inflammation and hypotony after posterior segment surgery. Ophthalmol Clin N Am 17(4):527–537CrossRef

Kapur R, Birnbaum AD, Goldstein DA, Tessler HH, Shapiro MJ, Ulanski LJ, Blair MP (2010) Treating uveitis-associated hypotony with pars planavitrectomy and silicone oil injection. Retina 30(1):140–145CrossRefPubMedPubMedCentral

Küçükerdönmez C, Beutel J, Bartz-Schmidt KU, Gelisken F (2009) Treatment of chronic ocular hypotony with intraocular application of sodium hyaluronate. Br J Ophthalmol 93(2):235–239CrossRefPubMed

Morse LS, McCuen BW (1991) The use of silicone oil in uveitis and hypotony. Retina 11(4):399–404CrossRefPubMed

O’Connell SR, Majji AB, Humayun MS, de Juan E Jr (2000) The surgical management of hypotony. Ophthalmology 107(2):318–323CrossRefPubMed

Pivetti-Pezzi P, Da Dalt S, La Cava M, Pinca M, De Gregorio F, Virno M (2000) Ibopamine treatment in chronic hypotony secondary to long-lasting uveitis. Eur J Ophthalmol 10(4):332–334PubMed

10.

Singh K, Byrd S, Egbert PR, Budenz D (1998) Risk of hypotony after primary trabeculectomy with antifibrotic agents in a black West African population. J Glaucoma 7(2):82–85CrossRefPubMed

11.

Tosi GM, Schiff W, Barile G, Yoshida N, Chang S (2005) Management of severe hypotony with intravitreal injection of viseoeplastic. Am J Ophthalmol 140(5):952–954CrossRefPubMed

12.

Schramm C, Spitzer M, Henke-Fahle S, Steinmetz G, Januschowski K, Heiduschka P, Geis-Gerstorfer J, Biedermann T, Bartz-Schmidt K, Szurman P (2012) The cross-linked biopolymer hyaluronic acid as an artificial vitreous substitute. Invest Ophthalmol Vis Sci 2(53(2)):613–621. doi:10.1167/iovs.11-7322 CrossRef

13.

Maruoka S, Matsuura T, Kawasaki K, Okamoto M, Yoshiaki H, Kodama M, Sugiyama M, Annaka M (2006) Biocompatibility of polyvinylalcohol gel as a vitreous substitute. Curr Eye Res 31:599–606CrossRefPubMed

14.

Keller GK, Dahlke C, Kuckelkorn R, Schrage N (2003) Experience with the artificial iris diaphragm in hypotonous eyes. Ophthalmology 100(3):203–208CrossRef

15.

Glynne GC, Freeman HM, Schepens CL (1970) Vitreous surgery. 3. Intraocular balloon: Instrument Report. Arch Ophthalmol 83:713–714CrossRef

16.

Tolentino FI, Refojo MF, Liu HS, Schepens CL and Freeman HM (1978) Intravitreous silicone balloon: an experimental study. Ophtalmic Surg. 73–80

17.

Gand H, Paroussis P, Skorpik C (1986) An intraocular balloon for silicone oil implantation. Graefes Arch Exp Clin Ophthalmol 224:18–20CrossRef

18.

Binder S (1986) Repair of retinl detachments with temporary balloon buckling. Retina 6:210–214CrossRefPubMed

19.

Kreissig I, Failer J, Lincoff H, Ferrari F (1989) Results of temporary balloon buckle in the treatment of 500 retinal detachments and a comparison with pneumatic retinopexy. Am J Ophthalmol 107:381–389CrossRefPubMed

20.

Peng YJ, Lu YT, Liu KS, Liu SJ, Fan L, Huang WC (2012) Biodegradable balloon-expandable self-locking polycaprolactone stents as buckling explants for the treatment of retinal detachment: an in vitro and in vivo study. J Biomed Mater Res A 101(1):167–175. doi:10.1002/jbm.a.34315, 2013 Jan PubMed

21.

Liu Y, Jiang Z, Gao Q, Ge J, Chen J, Cao X, Shen Q, Ma P (2010) Technical standards of a foldable capsular vitreous body in terms of mechanical, optical, and biocompatible properties. Artif Organs 34(10):836–845CrossRefPubMed

22.

Lin X, Wang Z, Jiang Z, Long C, Liu Y, Wang P, Jin C, Yi C, Gao Q (2012) Preliminary efficacy and safety of a silicone oil-filled foldable capsular vitreous body in the treatment of severe retinal detachment. Retina 32(4):729–741CrossRefPubMed

23.

Qian-Ying G, Yue F, Yan-Nian H (2015) Vitreous substitutes: challenges and directions. Int J Ophthalmol 18(8 (3)):437–440

24.

Barr S, Hill E, Bayat A (2009) Current implant surface technology: an examination of their nanostructure and their influence on fibroblast alignment and biocompatibility. Eplasty 9:e22PubMedPubMedCentral

25.

Fischer S, Carstesen D, Klee D, Walter P, Weinberger AW (2012) Surface-modified siliconefoils for intraocular implantation. Graefes Arch Clin Exp Ophthalmol 250(6):823–827CrossRefPubMed

26.

Groll J, Ameringer T, Spatz JP, Moeller M (2005) Ultrahin coatings form isocyanate- terminated star PEG prepolymers: Layer formation and characterization. Langmuir 1(21(5)):1991–1999CrossRef

27.

Gates DP (2009) Inorganic and organometallic polymers. Annual Rep ProgChem Sec A 105397–415

28.

Jones RG, Andos W, Chojnowski J (eds) (2000) Silicone-containing polymers: The science and technology of their synthesis and applications. Kluwer Academic Publishers, Boston, MA

29.

Colas A, Curtis J (2002) Silicone biomaterials: History and chemistry in biomaterials science: An introduction to materials in medicine, eds Ratner BD, Hoffmann AS, Schoen FJ, and Lemons JE, 80–6. Amsterdam, Elsevier Academic Press

30.

Janovsky EC, Kupper LL, Hulka BS (2000) Meta-analysis of the relation between silicone breast implants and the risk of connective tissue disease. N Engl J Med 342:781–790CrossRef

31.

Rachal WF, Burton TC (1979) Changing concepts of failure after retinal detachment surgery. Arch Ophthalmol 97:480–483CrossRefPubMed

32.

Ryan SJ (1985) The pathophysiology of proliferative vitreoretinopathy in its management. Am J Ophthalmol 100:188–193CrossRefPubMed

33.

Hauser J, Esenwein SA, Awakowicz P, Steinau HU, Köller M, Halfmann H (2011) Sterilization of heat-sensitive silicone implant material by low-pressure gas plasma. Biomed Instrum Technol 45(1):75–79CrossRefPubMed

34.

Bartzoka V, McDermott MR, Brook MA (1999) Protein-Silicone Interactions. Adv Mater 11(3):257–259CrossRef

35.

Heyes CD, Groll J, Möller M, Nienhaus GU (2007) Synthesis, patterning and applications of star-shaped poly(ethylene glycol) biofunctionalized surfaces. Mol Biosyst 3(6):419–430CrossRefPubMed

36.

Nagahama K, Saito T, Quchi T, Ohya Y (2010) Biodegradable nano-aggregates of star-shaped 8-arm PEG-PLLA block co-polymers for encapsulation of water-soluble macromolecules. J Biomater Sci Polym Ed 22:407–416CrossRef

37.

Satulovsky J, Caringano MA, Szleifer I (2000) Kinetic and thermodynamic control of protein adsorption. Proc Natl Acad Sci U S A 1(97(16)):9037–9041CrossRef

38.

Hoffmann J, Groll J, Heuts J, Rong H, Klee D, Ziemer G, Moeller M, Wendel HP (2006) Blood cell and plasma protein repellent properties of star-PEG-modified surface. J Biomater Sci Polym Ed 17(9):985–996CrossRefPubMed

39.

Cohen Tervaert JW, Kappel RM (2013) Silicone implant incompatibility syndrome (SIIS): A frequent cause of ASIA (Shoenfeld's syndrome). Immunol Res 56(2–3):293–298CrossRefPubMed

40.

Tervaert JW, Stegeman CA, Kallenberg CG (1998) Silicone exposure and vasculitis. Curr Opin Rheumatol 10:12–17CrossRefPubMed

41.

Parks CG, Conrad K, Cooper GS (1999) Occupational exposure to crystalline silica and autoimmune disease. Environ Health Perspect 107(S5):793–802CrossRefPubMedPubMedCentral

42.

Jewell M, Spear SL, Largent J, Oefelein MG, Adams WP Jr (2011) Anaplastic large T-cell lymphoma and breast implants: A review of the literature. Plast Reconstr Surg 128:651–661CrossRefPubMed

Title: Intraocular silicone implant to treat chronic ocular hypotony—preliminary feasibility data
Authors: Wesal Bayoudh
Markus Frentz
Dörthe Carstesen
Barbara Dittrich
Caroline Reismann
Norbert F. Schrage
Peter Walter
Andreas W. A. Weinberger
Publication date: 01-11-2016
Publisher: Springer Berlin Heidelberg
Published in: Graefe's Archive for Clinical and Experimental Ophthalmology / Issue 11/2016
Print ISSN: 0721-832X
Electronic ISSN: 1435-702X
DOI: https://doi.org/10.1007/s00417-016-3364-4

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Intraocular silicone implant to treat chronic ocular hypotony—preliminary feasibility data

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 11/2016

Outer retinal deformity detected by optical coherence tomography in eyes with foveal hypoplasia

Reply to the comment on “Outcomes of transconjunctıval sutureless 27-gauge vitrectomy wıth silicone oil infusion”

Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, Eighth Edition (2015) Eds: John E. Bennett, Raphael Dolin, Martin J. Blaser. ISBN: 13-978-1-4557-4801-3, Elsevier Saunders

Erratum to: Lamellar macular hole in high myopic eyes with posterior staphyloma: morphological and functional characteristics

Optic disc tilt direction affects regional visual field progression rates in myopic eyes with open-angle glaucoma

The influence of near work on myopic refractive change in urban students in Beijing: a three-year follow-up report