Validation of a Wearable Virtual Reality Perimeter for Glaucoma Staging, The NOVA Trial: Novel Virtual Reality Field Assessment.

Purpose: Compare estimated sensitivities of SITA-Standard to the RATA-Standard algorithm of the Radius virtual reality perimeter (VRP), and measure concordance in glaucoma staging. Methods: One hundred adult glaucoma patients-half with suspect or mild glaucoma, and half with moderate or severe-from five clinics performed four 24-2 visual field tests during a single visit, two with the Humphrey Field Analyzer (HFA) and two with Radius, in randomized order: HRHR or RHRH. Only one eye was tested per participant. We used the Wilcoxon rank sum test with Bonferroni correction to compare distributions of estimated sensitivities across all 54 test locations over the 15 to 40 dB measurement range of the Radius. Weighted kappa measured concordance in glaucoma staging between two masked glaucoma experts using Medicare definitions of severity. Results: A total of 62 OD and 38 OS eyes were tested. Estimated sensitivities for SITA-Standard and RATA-Standard were not significantly different for OD, but were for OS-likely because of SITA-Standard OD and OS being significantly different in our sample, but not for RATA-Standard. Low agreement was observed between 15 to 22 dB. Concordance in glaucoma staging was high for both graders: kappa = 0.91 and kappa = 0.93. Average test duration was 298 seconds for RATA-Standard and 341 seconds for SITA-Standard. The correlation in mean deviation was 0.94. Conclusions: Estimated sensitivities of RATA-Standard are comparable to SITA-Standard between 23 to 40 dB with high concordance in glaucoma staging. Translational Relevance: Radius VRP is statistically noninferior to HFA when staging glaucoma using Medicare definitions.

Toward a Real-world Optical Coherence Tomography Reference Database: Optometric Practices as a Source of Healthy Eyes.

SIGNIFICANCE: The reports from optical coherence tomography (OCT) instruments depend on a reference database (RDB) of healthy eyes. Although these RDBs tend to be relatively small, they are time consuming and expensive to obtain. A larger RDB should improve our ability to screen for diseases such as glaucoma. PURPOSE: To explore the feasibility of developing a large RDB from OCT scans obtained by optometrists as part of their pre-test gathering of information, we tested the hypothesis that these scans are of sufficient quality for an RDB and contain a relatively low base rate of glaucoma and other pathologies (OPs). METHODS: Optical coherence tomography widefield (12 × 9 mm) scans from 400 eyes of 400 patients were randomly selected from a data set of more than 49,000 scans obtained from four optometry sites. Based on a commercial OCT report and a previously validated reading center method, two OCT graders categorized eyes as unacceptable to use for RDB, healthy (H), optic neuropathy consistent with glaucoma (ON-G), glaucoma suspect, or OPs. RESULTS: Overall, 29 (7.25%) of the eyes were graded unacceptable. Of the remaining 371 eyes, 352 (94.9%) were graded H. Although, for one site, 7.4% of the eligible eyes were graded ON-G, the average for the other three sites was 1.4%. Adjustments of the reading center criteria resulted in exclusion of more than half of these ON-G and OP eyes. CONCLUSIONS: The OCT scans obtained from optometry practices as part of their pre-test regimen are of sufficient quality for an RDB and contain a relatively low base rate of glaucoma and OPs. With the suggested exclusion criteria, the scans from optometry practices that are primarily involved in refraction and medical screening services should yield a large, real-world RDB with improved specificity and a base rate of glaucoma and/or OPs comparable with existing RDB.

Negative Pressure Application via a Multi-Pressure Dial to Lower IOP in Patients with Suspected Glaucoma or Open Angle Glaucoma.

PRCIS: The multi-pressure dial applies localized periocular negative pressure to safely and effectively lower IOP and represents the first non-invasive, non-pharmacologic device for IOP reduction. OBJECTIVE: To evaluate the safety and effectiveness of the Multi-Pressure Dial (MPD) system, a device that applies periocular negative pressure to lower intraocular pressure (IOP). SETTING: 6 investigational sites, United States. DESIGN: Prospective, assessor-masked, randomized controlled trial. METHODS: Subjects with suspected glaucoma, ocular hypertension (OHTN), and open angle glaucoma (OAG) with baseline IOP ≥13 mmHg and ≤32 mmHg were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. The study eye negative pressure setting was programmed for 60% of the baseline IOP. The primary effectiveness endpoint was the proportion of study eyes versus control eyes achieving an IOP reduction ≥20% at Day 90. Secondary endpoints included the proportion of eyes achieving an IOP reduction ≥25% at Day 90 as well as the proportion of eyes achieving an IOP reduction ≥20% at Days 30 and 60. RESULTS: 116 eyes of 58 subjects completed the study. At the Day 90 visit, 89.7% ( n =52) of study eyes versus 3.4% ( n =2) of control eyes achieved an IOP reduction ≥20% ( P <0.001). At Day 90, 77.6% ( n =45) of study eyes achieved a ≥25% IOP reduction compared to 1.7% ( n =1) of control eyes ( P <0.001). The most commonly reported adverse events were lid (17.2% study eye, 7.8% control eye) and periorbital edema (14.1% study eye, 10.9% control eye). CONCLUSIONS: This trial demonstrates that the MPD safely and effectively lowers IOP in a group of patients that included glaucoma suspects, OHTN, and patients with OAG.

Assessing the Impact of En Face Retinal Nerve Fiber Layer Imaging on Clinical Decision Making for Glaucoma Suspects.

SIGNIFICANCE: Assessing and managing glaucoma are a complicated process in which experience plays a key role in decision making. Although advanced glaucoma is more easily diagnosed, patients with early glaucoma or who present with suspicious findings are more complicated. A need to aid clinicians in the decision-making process exists. PURPOSE: The purpose of this study was to assess the impact of en face ocular coherence tomography images to clinical decision making when added to standard presentations of circumpapillary retinal nerve fiber layer thickness and automated perimetry. METHODS: Thirty participants from two centers presenting either as a glaucoma suspect or for an initial glaucoma evaluation were enrolled. Six masked investigators were given standard presentations of circumpapillary retinal nerve fiber layer thickness and perimetry. They were asked if glaucomatous damage was present as well as a recommended plan of management on 5-point Likert scales. They were then given en face images of the retinal nerve fiber layer in three different presentations coupled with the standard presentation, and the questions were repeated. An intraclass correlation coefficient (ICC) was generated. RESULTS: The masked investigators had moderate agreement from the standard presentation for assessment (ICC = 0.67 [95% confidence interval {CI}, 0.54 to 0.80] and ICC = 0.69 [95% CI, 0.52 to 0.80], respectively), as well as with the addition of the en face images (ICC = 0.69; 95% CI, 0.56 to 0.81). The en face images tended to change decisions in both assessment and plan toward likely to have glaucoma and likely to start treatment. CONCLUSIONS: The addition of en face images to a standard presentation has an impact on clinical decision making. Although en face images seem to influence the decision toward likely to have glaucoma and likely to treat, it is unclear if this leads to a more accurate decision. Further investigations seem warranted to assess sensitivity and specificity of this approach.

The development of a reference database with the Topcon 3D OCT-1 Maestro.

IMPORTANCE: The paper presents the range for measurements taken with a new spectral domain optical coherence tomography (OCT) device to establish a reference database for discrimination purposes. OBJECTIVE: To report the range of thickness values for the new Topcon Maestro 3D OCT device with 2 scan size settings: the 12×9 mm wide field and 6×6 mm scans. DESIGN: Prospective, multicenter cohort study conducted at 7 clinical sites across the USA. SETTING: Primary eyecare clinics within academic, hospital, and private practice locations. PARTICIPANTS: Healthy volunteers; all enrolled participants underwent a complete ophthalmological examination to confirm healthy ocular status prior to being enrolled in the study. MAIN OUTCOME MEASURE: Average and 1st, 5th, 95th, and 99th percentile ranges for OCT parameters Early Treatment Diabetic Retinopathy Study macula full retinal thickness, ganglion cell + inner plexiform layer thickness (GCL + IPL), ganglion cell complex (GCC) thickness, circumpapillary retinal nerve fiber layer (cpRNFL) thickness. RESULTS: Three hundred and ninety-nine eyes of 399 subjects were included in the analysis. Mean (SD) age was 46.3 (16.3) years (range 18-88 years). Forty-three percent of the subjects were male. Mean (SD) measurements (in µm) for the 12×9 mm wide scan were as follows: foveal thickness=237.079 (20.899), GCL + IPL=71.363 (5.924), GCC=105.949 (8.533), cpRNFL=104.720 (11.829); measurements for the 6×6 mm scans were as follows: foveal thickness=234.000 (20.657), GCL + IPL=71.726 (5.880), GCC=106.698 (9.094), cpRNFL=104.036 (11.341). CONCLUSION: The overall normal thickness values reported with Topcon 3D OCT-1 Maestro were like those studies with OCT from different manufactures. The reference limits at the 1st, 5th, 95th, and 99th percentile points establish the thresholds for the quantitative comparison of the cpRNFL and the macula in the human retina to a database of known healthy subjects.