We appreciate the commenters’ interest in and keen evaluation of our report. Their query into adverse events (AEs) identified in our study underscores a critical limitation that exists in evaluating ophthalmology surgical interventions, and highlights the pressing need to develop and adopt standardized AE reporting protocols for vision research. The onus is currently on individual researchers to decide which AEs are relevant to a particular study, and AE selection and reporting remains without guidelines. This shortcoming causes difficulty in accurately assessing AE incidence across studies in a uniform way. It is confusing to describe an overall AE rate as a simple relationship between the total number of AEs vs study eyes while ignoring the varied clinical significance of different AEs—for example, mild conjunctival hyperemia substantively differs from hyphema. Additionally, studies using a proactive, well-monitored AE reporting process (including registered studies) tend to capture more AEs in general, leading to perceptually higher AE rates than studies without regulated reporting. In studying 10 eyes, for example, the unadjusted AE rate would be identical if all eyes experienced 1 vision-threatening permanent AE vs if a single eye experienced 10 minor transient AEs. Most AEs in our report were minor, transient, and not vision-threatening. We strongly encourage frank collaborative discourse among vision scientists to develop standardized AE reporting guidelines for human interventional trials.

During peer review, we were advised to report efficacy outcomes on a per-protocol (PP) basis that excluded subjects rescued with secondary surgical intervention such as trabeculectomy; this is reasonable because safety profiles significantly differ between trabeculectomy and minimally invasive surgeries. We also performed intention-to-treat (ITT) analyses, consistent with evolving human trials assessment trends. Of 65 enrollees, 12 required reoperation during follow-up and were excluded from PP analysis. Seven nonreoperated subjects withdrew or were lost to follow-up; additionally, 3 reoperated subjects were lost to follow-up and excluded from ITT assessment, giving a final N = 55 for ITT assessment. Both PP and ITT analyses of intraocular pressure (IOP) reduction rates are provided in the last two paragraphs of the Results. We appreciate that our wording should have better clarified application of these different analyses. This emphasizes the necessity of vision researchers to standardize outcome analysis and reporting approaches.

According to the prespecified analysis plan, our paper reported primary efficacy outcomes, that is, change in IOP and glaucoma medication use at postoperative 12 months. There are multitudinous possible efficacy endpoints in glaucoma trials—118 outcomes are commonly used in the glaucoma clinical trial literature, per a recent systematic review of Cochrane database glaucoma trials and protocols! This variability poses an ongoing challenge for comparing study results and underscores the need to adopt uniform outcomes nomenclature for glaucoma clinical trials. While unreasonable to provide a long list of additional efficacy outcomes from our study within this correspondence, as requested, of N = 55 at 12 months follow-up, 18, 13, 11, and 13 subjects used 0, 1, 2, and ≥3 medications, respectively, which was significantly reduced from baseline. Minimally invasive supraciliary microstenting effectively reduced IOP and glaucoma medication use in our cohort.

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Jan 6, 2017 | Posted by in OPHTHALMOLOGY | Comments Off on Reply
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