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

  • Retinal Disorders
  • Published:
Graefe's Archive for Clinical and Experimental Ophthalmology Aims and scope Submit manuscript

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.

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Acknowledgments

The technical assistance for this research project, from the Interdisciplinary Centre for Clinical Research BIOMAT within the Faculty of Medicine at the RWTH Aachen University, Aachen Center for Technology Transfer in Ophthalmology , Institute for Technical and Macromolecular Chemistry of RWTH Aachen University, is gratefully appreciated.

Author information

Authors and Affiliations

  1. Department of Ophthalmology, RWTH Aachen University, Pauwelsstr. 30, 52074, Aachen, Germany

    Wesal Bayoudh, Markus Frentz, Dörthe Carstesen, Caroline Reismann, Norbert F. Schrage, Peter Walter & Andreas W. A. Weinberger

  2. Institute of Technical and Macromolecular Chemistry, RWTH Aachen University, Aachen, Germany

    Barbara Dittrich

  3. ACTO Aachen Center for Technology Transfer in Ophthalmology, Aachen, Germany

    Markus Frentz & Norbert F. Schrage

  4. Department of Ophthalmology, Klinikum Köln-Merheim, Köln, Germany

    Caroline Reismann & Norbert F. Schrage

  5. Augenklinik Starnberg, Starnberg, Germany

    Andreas W. A. Weinberger

  6. Klinikum Dortmund gGmbh, Dortmund, Germany

    Wesal Bayoudh

Authors
  1. Wesal Bayoudh
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  2. Markus Frentz
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  3. Dörthe Carstesen
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  4. Barbara Dittrich
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  5. Caroline Reismann
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  6. Norbert F. Schrage
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  7. Peter Walter
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  8. Andreas W. A. Weinberger
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Corresponding author

Correspondence to Andreas W. A. Weinberger.

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Funding

The Interdisciplinary Centre for Clinical Research BIOMAT and the START program, both within the faculty of Medicine at the RWTH Aachen University, provided financial support in the form of grant funding. The sponsor had no role in the design or conduct of this research.

Conflict of interest

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers' bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

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Informed consent was obtained from all individual participants included in the study.

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Bayoudh, W., Frentz, M., Carstesen, D. et al. Intraocular silicone implant to treat chronic ocular hypotony—preliminary feasibility data. Graefes Arch Clin Exp Ophthalmol 254, 2131–2139 (2016). https://doi.org/10.1007/s00417-016-3364-4

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  • DOI: https://doi.org/10.1007/s00417-016-3364-4

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