Tube Versus Trabeculectomy IRIS Registry Study: 1-Year Secondary Treatment Outcomes.

PURPOSE: To describe 1-year secondary outcomes in the Tube Versus Trabeculectomy IRIS® (Intelligent Registry In Sight) Registry Study (TVTIRIS), and to compare to the TVT randomized controlled trial (TVTRCT). DESIGN: TVTIRIS was a retrospective cohort study. METHODS: The 2013-2017 IRIS Registry was used to identify eyes that received a tube shunt (tube) or trabeculectomy after a previous trabeculectomy and/or cataract surgery and had 1 year of follow-up. The TVTRCT compared a Baerveldt 350-mm2 glaucoma implant to trabeculectomy in similar eyes. RESULTS: In the TVTIRIS cohort, the tube (n = 236, 56.3%) and trabeculectomy (n = 183, 43.7%) groups had similar and significant reductions in intraocular pressure (IOP) from baseline to 1 year. In the tube group, IOP (mean ± SD) decreased from 26.6 ± 6.5 mm Hg at baseline to 14.3 ± 4.8 mm Hg at 1 year. In the trabeculectomy group, IOP decreased from 25.3 ± 6.4 mm Hg at baseline to 13.5 ± 5.2 mm Hg at 1 year. The trabeculectomy groups from both studies had similar 1-year IOP reduction (P = .18), although the TVTRCT cohort used fewer medications at all time points (P < .01). There were more pronounced differences in the mean IOP and medications between the tube groups in the 2 studies, presumably due to the inclusion of valved tubes in TVTIRIS. More reoperations occurred in TVTIRIS. CONCLUSIONS: The TVTIRIS tube and trabeculectomy groups had comparable 1-year IOP reduction, although trabeculectomy eyes used fewer glaucoma medications. The trabeculectomy group in TVTIRIS and TVTRCT had similar IOP and medication reduction at 1 year. Randomized controlled trials and electronic health record data both provide invaluable insight into surgical outcomes.

The effect of photographic light brightness on cup to disc ratio grading.

BACKGROUND: Digital optic disc photographs are integral to remote telehealth ophthalmology, yet no quality control standards exist for the brightness setting of the images. This study evaluated the relationship between brightness setting and cup/disc ratio (c/d) grading among glaucoma specialists. METHODS: Optic disc photographs obtained during routine examinations under anesthesia were collected to construct an image library. For each optic disc, photographs were obtained at 3 light intensity settings: dark, medium, and bright. From the image library, photograph triads (dark, medium and bright) of 50 eyes (50 patients) were used to construct the study set. Nine glaucoma specialists evaluated the c/d of the study set photographs in randomized order. The relationships between the brightness levels and the c/d grading as well as graders' years in practice and variability were evaluated. RESULTS: The c/d were graded as significantly larger in bright photographs when compared to photographs taken at the medium light intensity (0.53 vs 0.48, P < 0.001) as well as those taken at the dark setting (0.47, P < 0.001). In addition, no relationship was found between ophthalmologists' years in practice and the variability of their c/d grading (P = 0.76). CONCLUSION: Image brightness affects c/d grading of nonstereoscopic disc photographs. The brighter intensity is associated with larger c/d grading. Photograph brightness may be an important factor to consider when evaluating digital disc photographs.

Tube Versus Trabeculectomy IRISⓇ Registry 1-Year Composite Outcome Analysis with Comparisons to the Randomized Controlled Trial.

PURPOSE: This study compared 1-year results for the composite treatment outcome from the Tube Versus Trabeculectomy (TVT) randomized controlled trial (RCT) to those from an IRISⓇ (Intelligent Research In Sight) Registry cohort of analogous eyes. DESIGN: Retrospective clinical study with comparison to an RCT. METHODS: Subjects' eyes in the IRIS Registry received either a glaucoma drainage implant (tube) or underwent trabeculectomy after a previous trabeculectomy and/or cataract extraction and had data for 1-year follow-up analyses. OUTCOME: Eyes were classified as failing if they had hypotony (intraocular pressure (IOP) ≤5 mm Hg) or inadequate IOP control (IOP >21 mm Hg or not reduced at least 20% below baseline) on 2 consecutive follow-up visits after 3 months, a reoperation for glaucoma, or no light perception vision and as successful otherwise. Failure risk was compared by treatment, demographic, and clinical variables and was compared to analogous failure risks from the TVT RCT. RESULTS: The TVT IRIS Registry cohort included 419 eyes, 236 tube eyes (56.3%) and 183 trabeculectomy eyes (43.7%). In this cohort, there was no significant failure risk difference (12.3% for tube eyes and 16.4% for trabeculectomy eyes, P = 0.231). Comparing the studies, there was a significantly greater risk of failure in the TVT IRIS Registry tube eyes than in the TVT RCT tube eyes (3.8%; P <.001). Reasons for treatment failure included reoperations for glaucoma (none in the TVT RCT at 1 year). CONCLUSIONS: Our results were different from those in the TVT RCT. Possible reasons include non-Baerveldt tubes, greater severity among tube eyes, and practice patterns that reflect real-world data, which are different than those in RCTs.

The Tube Versus Trabeculectomy IRIS® Registry Study: Cohort Selection and Follow-up and Comparisons to the Randomized Controlled Trial.

PURPOSE: To assess the feasibility of replicating a randomized controlled trial (RCT) with a cohort of eyes, from IRIS® Registry data, analogous to the Tube Versus Trabeculectomy (TVT) RCT cohort and compare characteristics and follow-up. DESIGN: Comparison of RCT and IRIS Registry cohorts and follow-up. METHODS: We identified a cohort of IRIS Registry eyes (2013-2017) that received either a glaucoma drainage implant (tube) or trabeculectomy after a previous trabeculectomy and/or cataract extraction; extracted clinical and demographic characteristics for baseline surgery and follow-up visits through 1 year; and compared treatment groups in the IRIS Registry cohort and this cohort to the TVT RCT cohort. RESULTS: The IRIS Registry cohort included 419 eyes: 183 (43.7%) trabeculectomy; 236 (56.3%) tube. There were significant differences between treatment groups, including race (White: trabeculectomy 61.8%, tube 44.9%; Black: trabeculectomy 20.8%, tube 35.6%; P = .003) and the percentage of follow-up visits completed (trabeculectomy 88.4%, tube 83.8%, P = .004). There were also significant differences between the TVT IRIS Registry cohort and the TVT RCT cohort in the percentage of follow-up visits completed (IRIS Registry 85.6%, RCT 96.1%, P < .001) and in the probability of having a 1-year follow-up visit (IRIS Registry 81.4%, RCT 89.2%, P = .011). CONCLUSION: The TVT IRIS Registry cohort had several significant treatment group differences at baseline, whereas there had been none in the TVT RCT cohort. Follow-up in the TVT IRIS Registry cohort was inferior to that of the TVT RCT. Some data needed to refine the selection of eyes for the cohort were not available in the IRIS Registry.

Potential Lack of Association Between Three Vestigial Muscles in Humans: A Willed Body Donor Study.

PURPOSE: Anatomical agenesis within a population is not well understood, with variations including but not limited to complete absence, unilateral presence, or bilateral presence. Agenesis of human vestigial muscles including the palmaris longus (PL), fibularis tertius (FT), and psoas minor (PM) has been studied; however, the relationship between their presence and absence has not been examined. The purpose of this study is to analyze the prevalence of the PL, FT, and PM muscles, investigate any relationship of prevalence based on sex or race, and investigate any correlation between the presence or absence of each muscle within individual donors. METHODS: Twenty-three willed body donors were comprehensively dissected by medical students, and the presence or absence of the PL, FT, and PM muscles was recorded. RESULTS: The PL was present bilaterally in 87% of donors and absent bilaterally in 13%. The FT was present bilaterally in 96% of donors, and present unilaterally in 4% of donors. There was no evidence of total agenesis of the FT within our sample. The PM was present bilaterally in 39% of donors, and absent bilaterally in 61% of donors. No statistically significant relationship was indicated between muscle presence and the sex or race of the donors. No correlation between the presence or absence of each of the muscles was found. CONCLUSION: In this sample of willed body donors, there was no relationship between muscular agenesis of the vestigial muscles. This suggests that muscle agenesis is a local genetic developmental event at each muscle, and that there is not a single developmental event that leads to agenesis of multiple vestigial muscles. Further understanding of the agenesis of vestigial structures within populations and subpopulations can aid in physician diagnosis and understanding of the anatomical makeup of individuals.