Abstract
Purpose
The aim of this study is to assess the efficacy and complications of trabeculectomy with a biodegradable implant (ologen implant) vstrabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open-angle glaucoma in a prospective randomised clinical trial.
Methods
In the MMC group (10 patients), trabeculectomy was performed according to standard protocols. In the ologen group (10 patients) after standard trabeculectomy the implant was positioned on top of the scleral flap and no MMC was applied. Follow-up was continued for 12 months after surgery and included testing of intraocular pressure (IOP), visual acuity, visual field, ultrasound biomicroscopy, and filtering bleb score.
Results
The mean preoperative IOP was 24.8±8.9 mm Hg for all patients enrolled. At 1 year after surgery, the mean IOP was 15.6±2.4 mm Hg in the ologen group (P<0.01, 43% reduction) and 11.5±4.1 mm Hg in the MMC group (P<0.01, 50% reduction). No anti-glaucomatous medication was necessary in the MMC group in the first year of follow-up, whereas five patients in the ologen group required topical treatment. The absolute success rate was 100% in the MMC group and 50% in the ologen group (P=0.01). After 1 year, filtering blebs developed significantly more avascular areas in the MMC group (score=1.4) than in the ologen group (score=2.8; P<0.01).
Conclusion
The complete success rate using trabeculectomy with the ologen implant is lower than that achieved by trabeculectomy with MMC. However, the bleb morphology caused more problems in the MMC group (avascularity score).
Similar content being viewed by others
Log in or create a free account to read this content
Gain free access to this article, as well as selected content from this journal and more on nature.com
or
References
Azuara-Blanco A, Katz LJ . Dysfunctional filtering blebs. Surv Ophthalmol 1998; 43: 93–126.
Martini E, Laffi GL, Sprovieri C, Scorolli L . Low-dosage mitomycin C as an adjunct to trabeculectomy. A prospective controlled study. Eur J Ophthalmol 1997; 7: 40–48.
Wilkins M, Indar A, Wormald R . Intra-operative mitomycin C for glaucoma surgery. Cochrane Database Syst Rev 2005 Issue 4. Art. no.: CD002897..
Mac I, Soltau JB . Glaucoma-filtering bleb infections. Curr Opin Ophthalmol 2003; 14: 91–94.
Reibaldi A, Uva MG, Longo A . Nine-year follow-up of trabeculectomy with or without low-dosage mitomycin-c in primary open-angle-glaucoma. Br J Ophthalmol 2008; 92: 1666–1670.
Beckers HJ, Kinders KC, Webers CA . Five-year results of trabeculectomy with mitomycin C. Graefes Arch Clin Exp Ophthalmol 2003; 241: 106–110.
Young MJ, Borras T, Walter M, Ritch R . Potential applications of tissue engineering in glaucoma. Arch Ophthalmol 2005; 123: 1725–1731.
Chen HS, Ritch R, Krupin T, Hsu WC . Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ohthalmol Vis Sci 2006; 47: 5310–5314.
Hsu WC, Ritch R, Krupin T, Chen HS . Tissue bioengineering for surgical bleb defects: an animal study. Graefes Arch Clin Exp Ophthalmol 2008; 246: 709–717.
Papaconstantinou D, Georgalas I, Karmiris E, Diagourtas A, Koutsandrea C, Ladas I et al. Trabeculectomy with OloGen versus trabeculectomy for the treatment of glaucoma: a pilot study. Acta Ophthalmol 2010; 88: 80–85.
Klink T, Schrey S, Elsesser U, Klink J, Schlunck G, Grehn F . Interobserver variability of the Würzburg bleb classifiaction score. Ophthalmologica 2008; 222: 408–413.
Lüke C, Dietlein TS, Jacobi PC, Konen W, Krieglstein GK . A prospective randomized trial of viscocanalostomy versus trabeculectomy in open-angle glaucoma: a 1-year follow-up study. J Glaucoma 2002; 11: 294–299.
Cillino S, Di Pace F, Casuccio A, Calvaruso L, Morreale D, Vadalà M et al. Deep sclerectomy versus punch trabeculectomy with or without phacoemulsification: a randomized trial. J Glaucoma 2004; 13: 500–506.
Chiselita D . Non-penetrating deep sclerectomy versus trabeculectomy in primary-open-angle glaucoma surgery. Eye 2001; 15: 197–201.
Cairns JE . Trabeculectomy. Preliminary report of a new method. Am J Ophthalmol 1968; 66: 673–679.
Chen CW, Huang HT, Bair JS, Lee CC . Trabeculectomy with simultaneous topical application of mitomycin-c in refractory glaucoma. J Ocul Pharmacol 1990; 6: 175–182.
Okuda T, Higashide T, Fukuhira Y, Sumi Y, Shimomura M, Sugiyama K . A thin honeycomb-patterned film as an adhesion barrier in an animal model of glaucoma filtration surgery. J Glaucoma 2009; 18: 220–226.
Takeuchi K, Nakazawa M, Yamazaki H, Miyagawa Y, Ito T, Ishikawa F et al. Solid hyaluronic acid film and the prevention of postoperative fibrous scar formation in experimental animal eyes. Arch Ophthalmol 2009; 127: 460–464.
Tsurumaru N, Arai M, Teruya K, Sueda J, Yamakawa R . Seprafilm as a new antifibrotic agent following trabeculectomy in rabbit eyes. Jpn J Ophthalmol 2009; 53: 164–170.
Aptel F, Dumas S, Denis P . Ultrasound biomicroscopy and optical coherence tomography imaging of filtering blebs after deep clerectomy with new collagen implant. Eur J Ophthalmol 2009; 19: 223–230.
Stenzel KH, Miyata T, Rubin AL . Collagen as a biomaterial. Annu Rev Biophys Bioeng 1974; 3: 231–253.
Acknowledgements
PJ Dahlhausen & Co. GmbH (Emil-Hoffmann-Str. 53, 50996 Cologne, Germany) supported the study.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no conflict of interest.
Additional information
The sponsor had no role in the design or conduct of this research.
Rights and permissions
About this article
Cite this article
Rosentreter, A., Schild, A., Jordan, J. et al. A prospective randomised trial of trabeculectomy using mitomycin C vs an ologen implant in open angle glaucoma. Eye 24, 1449–1457 (2010). https://doi.org/10.1038/eye.2010.106
Received:
Revised:
Accepted:
Published:
Issue date:
DOI: https://doi.org/10.1038/eye.2010.106
Keywords
This article is cited by
-
Revision des PRESERFLO® MicroShunts mit Ologen und Mitomycin C
Die Ophthalmologie (2023)
-
Comparison of surgical outcomes with and without Ologen collagen matrix augmentation during XEN gel stent implantation
BMC Ophthalmology (2022)
-
Subconjunctival implantation of ologen Collagen Matrix to treat ocular hypotony after filtration glaucoma surgery
Eye (2017)
-
Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up
BMC Ophthalmology (2016)
-
Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial
BMC Ophthalmology (2016)
