Procedural treatments: New surgical options

Abstract

Commentary in this section is limited to devices that represent new technologies or improvements over preexisting technologies for IOP control that reached the marketplace during or after 1998. The order of device commentary herein is roughly based on the timing of their appearance by year or by the appearance of literature support. Evidence-based support for various technologies is rated by the author according to the American Academy of Ophthalmology's (AAO) scheme as Level I (strong evidence to support it), Level II (substantial evidence), or Level III (weak body of evidence) and the Oxford system, which is based on avail-able peer reviewed publications [1] (see Table 39.1). Commonly used study designs in clinical vision literature are interventional (including therapy), observational (no intervention), or others (meta-analyses and systematic reviews) [2]. To date, few new technologies for glaucoma can be considered well supported by high-level evidence. For many devices, there may be only one or no randomized clinical trials (RCTs) comparing them with existing therapies (highest level of evidence), or the RCTs available may not have been well done. Concerns with the quality of an RCT may revolve around the presence of an adequate control group, sufficiently long follow-up and compliance with the protocol, study execution in a manner that produces reliable and accurate data, the power of the study to adequately detect differences, and whether the analyses were performed using appropriate statistical methods. To evaluate the quality of a randomized trial, readers are advised to view the CONSORT statement (http://www.consort-statement.org/?o = 1011). For observational studies, readers may refer to the recently published STROBE document http://www.annals.org/cgi/content/full/147/8/573. Guidelines for evaluating inter-ventional case series and other study designs most fre-quently published in clinical vision journals have been published in Ophthalmology[2]. © 2010 Springer-Verlag Berlin Heidelberg.