Ophthalmic Technology Assessment Committee Glaucoma Panel: Brian A. Francis, MD1
; Kuldev Singh, MD, MPH2
; Shan C. Lin, MD3
; Elizabeth Hodapp, MD, MHS4
; Henry D. Jampel, MD, MHS5
; John R. Samples, MD6
; Scott D. Smith, MD, MPH7
Ophthalmology, July 2011, Vol 118, 1466-1480 © 2011 by the American Academy of Ophthalmology
Objective:To review the published literature and summarize clinically relevant information about novel, or emerging, surgical techniques for the treatment of open-angle glaucoma and to describe the devices and procedures in proper context of the appropriate patient population, theoretic effects, advantages, and disadvantages.
Design: Devices and procedures that have US Food and Drug Administration clearance or are currently in phase III clinical trials in the United States are included: the Fugo blade (Medisurg Ltd., Norristown, PA), Ex-PRESS mini glaucoma shunt (Alcon, Inc., Hunenberg, Switzerland), SOLX Gold Shunt (SOLX Ltd., Boston, MA), excimer laser trabeculotomy (AIDA, Glautec AG, Nurnberg, Germany), canaloplasty (iScience Interventional Corp., Menlo Park, CA), trabeculotomy by internal approach (Trabectome, NeoMedix, Inc., Tustin, CA), and trabecular micro-bypass stent (iStent, Glaukos Corporation, Laguna Hills, CA).
Methods: Literature searches of the PubMed and the Cochrane Library databases were conducted up to October 2009 with no date or language restrictions.
Main Outcome Measures: These searches retrieved 192 citations, of which 23 were deemed topically relevant and rated for quality of evidence by the panel methodologist. All studies but one, which was rated as level II evidence, were rated as level III evidence.
Results: All of the devices studied showed a statistically significant reduction in intraocular pressure and, in some cases, glaucoma medication use. The success and failure definitions varied among studies, as did the calculated rates. Various types and rates of complications were reported depending on the surgical technique. On the basis of the review of the literature and mechanism of action, the authors also summarized theoreticl advantages and disadvantages of each surgery.
Conclusions: The novel glaucoma surgeries studied all show some promise as alternative treatments to lower intraocular pressure in the treatment of open-angle glaucoma. It is not possible to conclude whether these novel procedures are superior, equal to, or inferior to surgery such as trabeculectomy or to one another. The studies provide the basis for future comparative or randomized trials of existing glaucoma surgical techniques and other novel procedures.
1Doheny Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California
2Department of Ophthalmology, Stanford University, Stanford, California
3Department of Ophthalmology, University of California, San Francisco, San Francisco, California
4Bascom Palmer Eye Institute, Miami, Florida
5Glaucoma Division, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland
6Department of Ophthalmology, Oregon Health and Sciences University, Portland, Oregon; Department of Surgery, Rocky Vista University, Parker, Colorado
7Edward S. Harkness Eye Institute, Columbia University, New York, New York