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      Novel Glaucoma Procedures

      , , , , , ,
      Ophthalmology
      Elsevier BV

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          Abstract

          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. 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). Literature searches of the PubMed and the Cochrane Library databases were conducted up to October 2009 with no date or language restrictions. 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. 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 theoretic advantages and disadvantages of each surgery. 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. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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          Most cited references3

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          Ab interno trabeculectomy: development of a novel device (Trabectome) and surgery for open-angle glaucoma.

          To design an instrument to selectively remove trabecular meshwork and Schlemm's canal inner wall (SCIW), and demonstrate its effectiveness by histologic analysis of treated cadaveric human tissue. The design parameters of the instrument were the ability to permanently remove a segment of trabecular meshwork and Schlemm's canal inner wall without causing damage to surrounding tissue, and to allow use with standard anterior segment surgical techniques and equipment via an ab interno approach. Treatment was applied to 20 segments of human corneoscleral rims. The treated areas were examined using a confocal microscope and compared with matching areas in untreated controls and simulated goniotomy. The resultant instrument system surgically removes the trabecular meshwork and Schlemm's canal inner wall from an anterior chamber approach. It consists of a disposable surgical handpiece with irrigation, aspiration, and electrocautery to focally ablate the target tissues. The attached console includes a high-frequency (550 KHz) electrosurgical generator and irrigation/aspiration controlled by a foot pedal. Histologic examination of specimens treated with the Trabectome displayed disruption of the trabecular meshwork and Schlemm's canal inner wall without damage to surrounding structures. The specimens treated by simulated goniotomy displayed significant damage to the outer wall of Schlemm's canal and the surrounding sclera. The controls showed no disruption or damage to any tissues. The Trabectome system is designed for performing trabeculectomy via an ab interno approach. It successfully removed sections of trabecular meshwork and Schlemm's canal inner wall with less injury to the adjacent tissue compared with goniotomy knife in vitro. Theoretically, this procedure should provide direct access of aqueous humor to Schlemm's canal.
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            Trabecular bypass stents decrease intraocular pressure in cultured human anterior segments.

            To determine the effect on intraocular pressure (IOP) of bypassing the trabecular meshwork in cultured human anterior segments. Prospective laboratory investigation using normal human eyes obtained at autopsy. Anterior segments from 21 eyes were placed in perfusion culture, and trabecular bypass stents were inserted through the trabecular meshwork, with the lumen of the tube opening into Schlemm's canal. Eyes received from one to four stents, placed equidistant apart. In eyes receiving one or two stents, additional stents were later added to a maximum of four per eye. Intraocular pressure was lowered after placement of a single stent, from 21.4 +/- 3.8 mm Hg to 12.4 +/- 4.2 (P < .001). This corresponded to an 84% increase in facility of outflow. Eyes receiving more than one stent had final IOP of 11.9 +/- 3.7 mm Hg. Nine eyes had sequential addition of stents, and seven of these had a further decrease of IOP (13.6 +/- 4.1 to 10.0 +/- 4.3; P = .02). Excision of the entire meshwork, between stents, dropped IOP to 6.3 +/- 3.2 mm Hg, indicating some residual meshwork or canal resistance remained even after placement of three stents. Bypass of the trabecular meshwork lowers IOP in cultured human anterior segments. One stent produced the greatest change in pressure. The sequential addition of more stents further lowered pressure in seven of nine eyes. This technique holds promise as a new clinical surgery for glaucoma.
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              A trabecular bypass flow hypothesis.

              To introduce a hypothesis that theorizes the effect of a trabecular bypass, a channel created through the trabecular meshwork, on the facility of outflow and the intraocular pressure (IOP).
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                Author and article information

                Journal
                Ophthalmology
                Ophthalmology
                Elsevier BV
                01616420
                July 2011
                July 2011
                : 118
                : 7
                : 1466-1480
                Article
                10.1016/j.ophtha.2011.03.028
                21724045
                fc42c080-afd7-453b-9b16-83cfd880302c
                © 2011

                https://www.elsevier.com/tdm/userlicense/1.0/

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