Early Experience With a Novel Miniaturized Spinal Cord Stimulation System for the Management of Chronic Intractable Pain of the Back and Legs.

INTRODUCTION: A novel, spinal cord stimulation (SCS) system with a battery-free miniaturized implantable pulse generator (IPG) was used in this feasibility study. The system uses an external power source that communicates bidirectionally with the IPG (< 1.5 cm3). Human factors, subject comfort, and effects on low back and leg pain were evaluated in this first-in-human study. MATERIALS AND METHODS: A prospective, multicenter, open-label clinical trial was initiated to evaluate the safety and performance of a novel miniaturized stimulator in the treatment of chronic, intractable leg and low-back pain. Eligible subjects were recruited for the study and gave consent. Subjects who passed the screening/trial phase (defined as ≥ 50% decrease in pain) continued to the long-term implant phase and were followed up at predefined time points after device activation. Interim clinical and usability outcomes were captured and reported at 90 days. RESULTS: Results of 22 subjects who chose a novel pulsed stimulation pattern therapy using the battery-free IPG (< 1.5 cm3) are described here. At 90-days follow-up, the average pain reduction was 79% in the leg (n = 22; p < 0.0001) and 76% in the low back (n = 21; p < 0.0001) compared with baseline. Responder rates (≥ 50% pain relief) at 90 days were 86% in leg pain (19/22) and 81% in low-back pain (17/21). Subjects rated the level of comfort of the external wearable power source to be 0.41 ± 0.73 at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). DISCUSSION: These interim results from the ongoing study indicate the favorable efficacy and usability of a novel, externally powered, battery-free SCS IPG (< 1.5 cm3) for leg and low-back pain. Study subjects wore the external power source continuously and found it comfortable, and the system provided significant pain relief. These preliminary findings warrant further investigation. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is ACTRN12618001862235.

A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain.

OBJECTIVES: The aim of this article is to discuss the possible mechanisms of action (MOAs) and results of a pilot study of a novel, anatomically placed, and paresthesia-independent, neurostimulation waveform for the management of chronic intractable pain. MATERIALS AND METHODS: A novel, multilayered pulsed stimulation pattern (PSP) that comprises three temporal layers, a Pulse Pattern layer, Train layer, and Dosage layer, was developed for the treatment of chronic intractable pain. During preliminary development, the utility was evaluated of anatomical PSP (aPSP) in human subjects with chronic intractable pain of the leg(s) and/or low back, compared with that of traditional spinal cord stimulation (T-SCS) and physiological PSP. The scientific theory and testing presented in this article provide the preliminary justification for the potential MOAs by which PSP may operate. RESULTS: During the pilot study, aPSP (n = 31) yielded a greater decrease in both back and leg pain than did T-SCS (back: -60% vs -46%; legs: -63% vs -43%). In addition, aPSP yielded higher responder rates for both back and leg pain than did T-SCS (61% vs 48% and 78% vs 50%, respectively). DISCUSSION: The novel, multilayered approach of PSP may provide multimechanistic therapeutic relief through preferential fiber activation in the dorsal column, optimization of the neural onset response, and use of both the medial and lateral pathway through the thalamic nuclei. The results of the pilot study presented here suggest a robust responder rate, with several subjects (five subjects with back pain and three subjects with leg pain) achieving complete relief from PSP during the acute follow-up period. These clinical findings suggest PSP may provide a multimechanistic, anatomical, and clinically effective management for intractable chronic pain. Because of the limited sample size of clinical data, further testing and long-term clinical assessments are warranted to confirm these preliminary findings.

Characteristics, Outcomes, and Trends of Patients With COVID-19-Related Critical Illness at a Learning Health System in the United States.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic continues to surge in the United States and globally. OBJECTIVE: To describe the epidemiology of COVID-19-related critical illness, including trends in outcomes and care delivery. DESIGN: Single-health system, multihospital retrospective cohort study. SETTING: 5 hospitals within the University of Pennsylvania Health System. PATIENTS: Adults with COVID-19-related critical illness who were admitted to an intensive care unit (ICU) with acute respiratory failure or shock during the initial surge of the pandemic. MEASUREMENTS: The primary exposure for outcomes and care delivery trend analyses was longitudinal time during the pandemic. The primary outcome was all-cause 28-day in-hospital mortality. Secondary outcomes were all-cause death at any time, receipt of mechanical ventilation (MV), and readmissions. RESULTS: Among 468 patients with COVID-19-related critical illness, 319 (68.2%) were treated with MV and 121 (25.9%) with vasopressors. Outcomes were notable for an all-cause 28-day in-hospital mortality rate of 29.9%, a median ICU stay of 8 days (interquartile range [IQR], 3 to 17 days), a median hospital stay of 13 days (IQR, 7 to 25 days), and an all-cause 30-day readmission rate (among nonhospice survivors) of 10.8%. Mortality decreased over time, from 43.5% (95% CI, 31.3% to 53.8%) to 19.2% (CI, 11.6% to 26.7%) between the first and last 15-day periods in the core adjusted model, whereas patient acuity and other factors did not change. LIMITATIONS: Single-health system study; use of, or highly dynamic trends in, other clinical interventions were not evaluated, nor were complications. CONCLUSION: Among patients with COVID-19-related critical illness admitted to ICUs of a learning health system in the United States, mortality seemed to decrease over time despite stable patient characteristics. Further studies are necessary to confirm this result and to investigate causal mechanisms. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience.

PURPOSE: Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain. METHODS: Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0-10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2-C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza® system (Nevro Corp., Redwood City, CA, USA) and included in the safety and effectiveness evaluation at 3 months post-implant (primary endpoint assessment, PEA) and followed to 12 months. RESULTS: Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed. CONCLUSIONS: Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.

Effect of a punctal plug on ocular surface disease in patients using topical prostaglandin analogues: a randomized controlled trial.

IMPORTANCE: Ocular surface disease (OSD) is common and can reduce treatment compliance and quality of life. BACKGROUND: To determine whether a punctal plug improves OSD and reduces intraocular pressure (IOP) in patients using prostaglandin analogue monotherapy. DESIGN: Randomized controlled trial. PARTICIPANTS: Sixty eligible subjects aged >18 years with symptomatic OSD from glaucoma clinics were invited to participate. Lacrimal or glaucoma surgery, lid malposition and contact lens wear were exclusion criteria. METHODS: One eye received an inferior punctal plug, leaving the fellow eye as a control. MAIN OUTCOME MEASURES: Ocular surface disease index (OSDI), tear film breakup time (TF-BUT), Oxford cornea score, tear osmolarity and IOP were compared at baseline and 6 weeks by masked investigators. RESULTS: From 60 eligible, 48 (80.0%) participated (mean age 69.6 years; 60.0% female). OSDI reduced following plug insertion (mean difference [MD] 14.5, 95% confidence interval [CI] 5.06-23.94, P < 0.001). Compared to control eyes, in eyes receiving plugs the TF-BUT increased (MD 2.3 s, 95% CI 1.4-3.2, P < 0.001), the Oxford cornea score decreased (MD 0.5, 95% CI 0.3-0.7, P < 0.001), and tear osmolarity decreased (MD 10 mOsm/L, 95% CI 3.5-16.5, P = 0.003). Punctal plugs resulted in a significantly lowered IOP (MD 1.5 mmHg, 95% CI 0.1-2.9, P = 0.032). Sub-group analyses showed similar efficacy regardless of prostaglandin preservative status or lubricant drop use. Plugs were well tolerated but extrusion occurred in 8.5%, and epiphora increased in 6.5% eyes. CONCLUSIONS AND RELEVANCE: Punctal plug insertion improves subjective and objective measures of OSD and results in a reduced IOP in patients with symptomatic ocular surface disease using prostaglandin analogue monotherapy.

Results From the Partnership for Advancement in Neuromodulation Registry: A 24-Month Follow-Up.

OBJECTIVE: This longitudinal, clinical outcome study was a multicenter, prospective, observational, registry with a 24-month assessment of patients implanted with spinal cord stimulation (SCS) systems for the management of chronic pain of the trunk and/or limbs. METHODS: On informed consent and institutional review board approval, 614 patients from 39 sites were enrolled within 30 days following permanent SCS system implantation. Medication usage, patient-reported pain relief (PRP), categorical ratings of pain relief, pain disability index scores (PDI), quality of life (QoL), and patient satisfaction were assessed at enrollment, 3-, 6-, 12-, 18-, and 24-month postimplant. Device-related adverse events (AEs) were recorded and reported. RESULTS: Across all visits, statistically significant improvements were reported on all outcome measures. Mean PRP was 58.5% (± 26.4) at 3 months, 56.8% (± 29.2) at 6 months, 57.7% (± 28.9) at 12 months, 55.6% (± 29.8) at 18 months, and 56.3% (± 30.3) at 24 months. More than 65% of patients at any visit reported a PRP ≥ 50%. Mean PDI scores reduced from 46.9 points at baseline to 32.7, 31.8, 31.5, 32.1, 32.1 points at 3, 6, 12, 18, and 24 months (p ≤ 0.0001), respectively. Greater than 76% of patients at any visit were satisfied with their therapy. The majority of patients categorized pain relief as excellent or good on a 5-item scale and reported overall QoL as greatly improved or improved on a 5-item scale. An average of 88% of patients stopped, decreased, or did not change dose of narcotics/opioids. The most common AE was diminished or loss of pain relief in 11.4% of enrolled patients. CONCLUSIONS: Most patients experienced substantial pain relief and a significant improvement in all outcome measures. These results further support the safety, efficacy, and sustainability of SCS in clinical practice.

Effectiveness of cervical spinal cord stimulation for the management of chronic pain.

INTRODUCTION: Scientific evidence supports spinal cord stimulation (SCS) as a cost-effective treatment option that, for many disease states, should be employed earlier in the treatment continuum. Reimbursement for SCS in the cervical spine has recently been challenged based on supposed lack of clinical literature. To refute this assumption, we analyzed data from an international registry to support the use of cervical SCS. MATERIALS AND METHODS: The following outcomes were collected as part of an institutional review board-approved, prospective, multicenter, international registry: pain relief, Pain Disability Index (PDI) score, quality of life (QoL), and satisfaction at 3, 6, and 12 months post-implantation. Descriptive statistics are provided for all measures. Changes from baseline in PDI scores were analyzed using Tukey's pairwise comparisons. RESULTS: Thirty-eight patients underwent implantation of SCS leads in the cervical spine at 16 study sites in the United States and 3 international study sites. Direct patient report of percentage of pain relief was 54.2%, 60.2%, and 66.8% at 3, 6, and 12 months post-implantation, respectively. Pain relief was categorized as excellent/good by 61.6% of patients at 3 months, with similar results observed at 6 and 12 months. PDI scores were significantly reduced at all time points. At 3 months post-implantation, 92.4% of patients indicated they were very satisfied/satisfied with the SCS device. No patients indicated that they were dissatisfied. Overall QoL was reported as improved/greatly improved by 73.1% of patients at 3 months. Similar results for QoL and satisfaction were reported at 6 and 12 months. CONCLUSION: The results suggest that the use of SCS in the cervical spine is a medically effective method of pain management that satisfies and improves the QoL of most patients. The use of SCS can reduce the high cost of direct medical treatment of pain, as well as increasing the productivity of patients, and therefore should be reimbursed in appropriately selected patients.

Human-robot planar co-manipulation of extended objects: data-driven models and control from human-human dyads.

Human teams are able to easily perform collaborative manipulation tasks. However, simultaneously manipulating a large extended object for a robot and human is a difficult task due to the inherent ambiguity in the desired motion. Our approach in this paper is to leverage data from human-human dyad experiments to determine motion intent for a physical human-robot co-manipulation task. We do this by showing that the human-human dyad data exhibits distinct torque triggers for a lateral movement. As an alternative intent estimation method, we also develop a deep neural network based on motion data from human-human trials to predict future trajectories based on past object motion. We then show how force and motion data can be used to determine robot control in a human-robot dyad. Finally, we compare human-human dyad performance to the performance of two controllers that we developed for human-robot co-manipulation. We evaluate these controllers in three-degree-of-freedom planar motion where determining if the task involves rotation or translation is ambiguous.

Treating Chronic, Intractable Pain with a Miniaturized Spinal Cord Stimulation System: 1-Year Outcomes from the AUS-nPower Study During the COVID-19 Pandemic.

Purpose: Spinal cord stimulation (SCS) is a highly effective treatment for chronic neuropathic pain. Despite recent advances in technology, treatment gaps remain. A small SCS system with a miniaturized implantable pulse generator (micro-IPG; <1.5 cm3 in volume) and an externally worn power source may be preferred by patients who do not want a large, implanted battery. We report here the long-term outcomes from the first-in-human study evaluating the safety and performance of a new neurostimulation system. Patients and Methods: This was a prospective, multi-center, open-label, single-arm study to evaluate this SCS system, in the treatment of chronic, intractable leg and low-back pain. Consented subjects who passed screening continued on to the long-term phase of the study. One-year, patient-reported outcomes (PRO's) such as pain (Numeric Rating Scale, NRS), functional disability, quality of life, and mood were captured. Results: Twenty-six (26) evaluable subjects with permanent implants were included in this analysis. The average leg pain NRS score decreased from 6.8 ± 1.2 at baseline to 1.1 ± 1.2 at the end of the study (p < 0.001), while the average low-back pain NRS score decreased from 6.8 ± 1.2 to 1.5 ± 1.2 (p < 0.001). The responder rate (proportion with ≥50% pain relief) was 91% in the leg(s) and 82% in the low back. There were significant improvements in functional disability (Oswestry Disability Index) and in mood (Beck Depression Inventory), demonstrating a 46% and 62% improvement, respectively (p < 0.001). Eleven-point Likert scales demonstrated the wearable to be very comfortable and very easy to use. Conclusion: There were considerable challenges conducting a clinical study during the COVID-19 pandemic, such as missed study programming visits. Nevertheless, subjects had significant PRO improvements through 1-year. The small size of the implanted device, along with a proprietary waveform, may allow for improved SCS outcomes and a drop in incidence of IPG-pocket pain.

There is a trend for the diagnosis of glaucoma to be made at an earlier stage in 2010 compared to 2008 in Oxford, United Kingdom.

PURPOSE: New guidelines on glaucoma diagnosis and management were published by the National Institute of Clinical Excellence (NICE) in 2009. The aim of this study was to determine whether these guidelines on glaucoma referral have changed the numbers of patients diagnosed with glaucoma in Oxford and whether the severity of disease at presentation has altered between 2008 and 2010. METHODS: A retrospective study was undertaken of patients referred to a glaucoma case-finding clinic at the Oxford Eye Hospital in 2008 and 2010. Severity of glaucoma was assigned on the basis of the worse eye and defined according to mean deviation (MD) on 24-2 Humphrey visual field testing, with early glaucomatous visual field defects defined as MD less than -6 dB, moderate defects as MD between -6 and -12 dB and severe defects as MD more than -12 dB. Statistical analysis was undertaken using Chi squared and Mann Whitney tests. RESULTS: The number of referrals to this clinic increased from 521 patients in 2008, to 895 patients in 2010. 85 (16.3%) patients were diagnosed with ocular hypertension in 2008, compared to 144 (16.1%) in 2010. The number of patients diagnosed with glaucoma increased from 94 cases in 2008 to 113 cases in 2010, although the percentage of referrals diagnosed with glaucoma fell from 18.1% to 12.6%. More patients diagnosed with glaucoma in 2010 had early disease (61.9% in 2010 vs 48.8% in 2008, p = 0.03). Patients found to have glaucoma in 2010 had less severe visual field defects than in 2008: patients presented with a lower mean deviation (-6.36 dB in 2010, -7.95 dB in 2008, p = 0.03) and lower pattern standard deviation (5.44 dB in 2010, 6.64 dB in 2008, p = 0.02). However, there was no significant difference between age of presentation (65.1 years in 2010, 65.2 years in 2008, p = 0.82), and IOP (21.62 mmHg in 2010, 23.15 mmHg in 2008, p = 0.22). CONCLUSIONS: There has been a significant increase in number of referrals to the glaucoma case-finding clinic in Oxford between 2008 and 2010. The introduction of NICE referral guidelines in 2009 has had the benefit of increasing the absolute number of patients detected with glaucoma and has resulted in more patients being diagnosed with early disease. More effort needs to be made to reduce the number of false positive referrals. In addition, the guidelines on referral of individuals with ocular hypertension need to be reconsidered.

Trends in Haptic Communication of Human-Human Dyads: Toward Natural Human-Robot Co-manipulation.

In this paper, we analyze and report on observable trends in human-human dyads performing collaborative manipulation (co-manipulation) tasks with an extended object (object with significant length). We present a detailed analysis relating trends in interaction forces and torques with other metrics and propose that these trends could provide a way of improving communication and efficiency for human-robot dyads. We find that the motion of the co-manipulated object has a measurable oscillatory component. We confirm that haptic feedback alone represents a sufficient communication channel for co-manipulation tasks, however we find that the loss of visual and auditory channels has a significant effect on interaction torque and velocity. The main objective of this paper is to lay the essential groundwork in defining principles of co-manipulation between human dyads. We propose that these principles could enable effective and intuitive human-robot collaborative manipulation in future co-manipulation research.

Retrospective Analysis of Real-World Outcomes of 10 kHz SCS in Patients with Upper Limb and Neck Pain.

BACKGROUND: Patients living with chronic upper limb and neck (ULN) pain are reliant on often ineffective therapies as they face limited options for effective long-term treatment. OBJECTIVE: Prospective clinical studies have demonstrated that high-frequency spinal cord stimulation at 10 kHz (10 kHz SCS) is effective in treating chronic pain in multiple etiologies including ULN pain. This study aimed at validating the findings from clinical studies on ULN in a real-world cohort. STUDY DESIGN: A retrospective, observational review. SETTING: A multicenter review between April 2016 and August 2019. PATIENTS AND METHODS: Anonymized data were extracted from a real-world database of 47 consecutive patients aged ≥18 years of age with chronic upper limb and/or neck pain who were trialed and permanently implanted with 10 kHz SCS. Patient-reported pain relief, quality of life, function, sleep and medication use were extracted from anonymised patient records where available. Responder rates, defined as the proportion of patients with at least 50% pain relief at the end of trial and the last visit after implantation, were calculated. RESULTS: All patients reported successful response (≥50% pain relief) at the end of trial and >75% patients continued to respond to the therapy at the last follow-up period. Majority (72%) of patients reported improvement in function, about half of the patients (53%) reported improvement in sleep and one-third of the patients (36%) reported reducing their medication at last follow-up. CONCLUSION: 10 kHz SCS provides durable pain relief to patients with chronic upper limb and neck pain.

Cementless surface replacement arthroplasty of the shoulder with biologic resurfacing of the glenoid.

BACKGROUND: We report a retrospective review of surface replacement hemiarthroplasty of the shoulder with biologic resurfacing of the glenoid, for relatively young patients suffering from advanced glenohumeral arthritis. It was hoped that the resurfacing fascia would prevent glenoid erosion for a period of time. METHODS: This surgery was performed by two surgeons between 1996 and 2005. The indications for the arthroplasty were severe pain and limitation of function, in relatively young patients with advanced glenohumeral arthritis but an intact rotator cuff. RESULTS: Eighteen shoulders, with an average follow-up of 4.8 years (range 2-10.6), were available for assessment. The average age was 54.8 years. Postoperative Constant-Murley Score averaged 71.4 points; the mean sex- and age-adjusted Constant Score was 83.9%. The mean American Shoulder and Elbow Surgeons score was 74.4 points. Average active forward elevation was 130 degrees. Eighty three percent of the patients were satisfied with the long-term result. Radiographic follow-up demonstrated that none of the prostheses was loose; however moderate to severe glenoid erosion was present in 56% of shoulders. CONCLUSIONS: We conclude that this procedure is useful in the treatment of younger patients suffering from advanced glenohumeral arthritis of the shoulder; however the interposed anterior capsule did not protect the glenoid from mid-term erosion by the humeral prosthesis. LEVEL OF EVIDENCE: Level IV, retrospective case series.

High-frequency spinal cord stimulation at 10 kHz for widespread pain: a retrospective survey of outcomes from combined cervical and thoracic electrode placements.

OBJECTIVE: To report on the long-term outcomes for patients receiving paraesthesia-free high-frequency spinal cord stimulation (HF10-SCS) at 10 kHz for the treatment of combined upper and lower body neuropathic/nociplastic pain syndromes including chronic widespread pain/fibromyalgia. MATERIALS AND METHODS: Forty-five patients with widespread (both upper and lower body) neuropathic/nociplastic pain syndromes underwent a trial of combined cervical and thoracic HF10-SCS leads placed over the C2/T2 or C2/T9 vertebral levels, or three leads placed over the C2/T2/T9 vertebral levels. Thirty-eight patients proceeded to permanent implant, resulting in a trial to implant conversion rate of 84.4%. Patients were followed up an average of 2.3 ± 1.7 years post-permanent implant. Patient outcomes were recorded. RESULTS: A statistically significant reduction of 3.5 ± 1.6 on the 10-point numerical rating scale (NRS) at 2.3 ± 1.7 years post-permanent implant was observed (baseline: 7.1 ± 0.8 vs. follow up: 3.7 ± 1.3) (p ≤ 001). Likewise, a reduction in disability (Roland Morris Disability Questionnaire) was also observed; baseline: 12.3 ± 5.1 vs. follow up: 7.8 ± 5.9. Similar trends were observed in a working capacity, with 20/31 (64.5%) of the work eligible patients employed at follow-up, compared with only 8/31 (25.8%) at baseline. Opioid pain medication use reduced and over 90% of patients were satisfied with their treatment outcome. No long-term adverse events were observed. CONCLUSIONS: HF10-SCS at 10 kHz provides long-term widespread pain relief when leads are staggered across the cervical and thoracic spine. The improved return to work outcomes and opiate reductions suggest that cost-effectiveness as well as clinical effectiveness may be achieved with this treatment approach.

Twenty-year outcomes in patients with newly diagnosed glaucoma: mortality and visual function.

BACKGROUND/AIMS: To determine the mortality within 20 years of diagnosis of chronic open-angle glaucoma (COAG) and visual acuity and visual field progression of a cohort followed for 20 years. METHODS: Twenty years following the diagnosis of COAG in 68 of 436 (16%) patients seen in a glaucoma case-finding clinic, visual and mortality outcomes were audited from medical records. Causes of death were obtained from general practitioner records and death certificates. Probability of death was calculated using a Kaplan-Meier survival curve. The visual field of each eye of survivors was graded using a nine-stage severity scale. Visual outcome was analysed at the 20-year follow-up visit. RESULTS: From 68, 14 (21%) were lost to follow-up. In the remaining 54, 20 (37%) were alive 20 years after diagnosis. Of 63% who died, mean age of death was 84 years, most commonly due to vascular disease. Mean age at presentation of those who died was 73.7 years versus 63.2 years for survivors (P=0.001). The median time to death was 16 years. On visual field analysis, nearly half (48.9%) of eyes did not deteriorate, but 28.3% eyes deteriorated by more than two stages. Those who died had worse final visual acuity than survivors (P<0.001). Three who died were registered severely visually impaired mainly from macular disease, but no survivors were registered (P<0.001). CONCLUSION: In this cohort, approximately two-thirds of patients with glaucoma died within 20 years of diagnosis. In most older patients with glaucoma, the overall goal of preventing visual handicap and blindness is achievable 20 years after diagnosis.

Microperimetry and optical coherence tomography imaging in the fellow eye of patients with unilateral focal ischaemic glaucoma.

PURPOSE: To determine whether microperimetry or optical coherence tomography (OCT) imaging can detect early disease in the fellow eye of patients with unilateral focal ischaemic glaucoma. METHODS: Thirty-seven consecutive adult patients with unilateral focal ischaemic glaucoma with a unilateral split-fixation visual field defect on standard automated perimetry (SAP) with normal SAP in the fellow eye were selected. All patients underwent microperimetry (MAIA, CenterVue, Italy) of the central 10 degrees and OCT imaging (Spectralis, Heidelberg Engineering, Germany) of the retinal nerve fibre layer of both eyes. The main outcome measures were reduced retinal sensitivity on microperimetry and/or retinal nerve fibre layer thinning on OCT imaging of the fellow eye. RESULTS: Thirty fellow eyes had abnormal global thresholds on microperimetry, and 20 had abnormal OCT imaging studies. Kappa agreement between tests in fellow eyes was poor (p = 0.2546). Fixation was significantly poorer in fellow eyes on microperimetry when compared to eyes with glaucoma (p < 0.003). In the fellow eyes that were abnormal, microperimetry identified reduced retinal sensitivity at fixation. CONCLUSION: Microperimetry detects reduced retinal sensitivity close to fixation and OCT detects focal thinning of the retinal nerve fibre layer in the fellow eye of most patients with presumed unilateral focal ischaemic glaucoma. Further studies are required to correlate specific optic disc features on OCT imaging with microperimetry in the fellow eye of this patient group.

The effect of trabeculectomy surgery on the central visual field in patients with glaucoma using microperimetry and optical coherence tomography.

PURPOSE: To determine the functional and structural effects of trabeculectomy surgery on patients with advanced glaucoma and central visual field defects in the early post-operative period. METHODS: Thirty consecutive adult subjects with advanced glaucoma requiring trabeculectomy surgery and an established visual field defect within 10° of fixation underwent microperimetry (MAIA MP-1, CenterVue, Padova, Italy) and optic disc optical coherence tomography (OCT) imaging (Spectralis, Heidelberg Engineering, Germany) pre-operatively, and 1 month and 3 months following trabeculectomy surgery. Main outcome measures were post-trabeculectomy change in mean threshold on microperimetry and nerve fibre layer thickness on OCT. Fellow eyes were used as controls. RESULTS: The mean change in MP average threshold values from pre-operative to post-operative was 0.6 ± 1.9 dB for treated eyes and 0.1 ± 1.3 dB for control eyes (p = 0.14) at 1 month and 0.2 ± 2.3 and -0.3 ± 1.6 dB at 3 months (p = 0.22). Mean change in global nerve fibre layer thickness was -0.6 and -0.5 µm for operated and control eyes, respectively (p = 0.83), at 1 month and 0.8 and -0.4 µm at 3 months (p = 0.88). The kappa agreement for structure-function correlation between OCT and MP was 0.735 (confidence interval 0.59-0.88) (p < 0.005). CONCLUSIONS: Central visual function and retinal nerve fibre layer thickness appear to be preserved in glaucoma patients with central visual field defects undergoing trabeculectomy surgery in the early post-operative period. These data may inform glaucoma surgeons considering trabeculectomy surgery in this patient group.

Ten-year outcomes in newly diagnosed glaucoma patients: mortality and visual function.

OBJECTIVES: To determine the mortality within ten years of diagnosis of chronic open angle glaucoma and the visual field progression amongst survivors of a group of patients who were followed for 10 years. PATIENTS AND METHODS: Of the 436 patients seen in a glaucoma case-finding clinic between July 1994 and December 1995 a diagnosis of chronic open angle glaucoma was made in 65. Ten years after diagnosis the outcome of the 57 patients who were treated at the Oxford Eye Hospital was determined. The causes of death were obtained from the general practitioner records and from the official death certificates. The probability of death was analysed using a Kaplan-Meier survival curve. The visual field of each eye of survivors was graded using a nine-stage severity scale. The visual outcome was analysed at the 10-year follow up visit. FINDINGS: Seventeen patients (29.8%) died during the 10-year period, including nine from cardiovascular disease. The mean (SD) age at presentation of those that died was 76.4 years (9.7) compared with 69.5 years (10.9) for survivors (p = 0.029). Using a nine-stage grading system, 42 eyes (52.5%) did not deteriorate, 30 eyes (37.5%) deteriorated by one stage, seven eyes (8.75%) two stages and one eye (1.25%) three stages over the 10-year period. The average time to first deterioration by one stage was 8.51 years (CI 7.92 to 9.10). The mean (SD) intraocular pressure was 25.6 mmHg (5.8 mmHg) on presentation and 15.7 mmHg (3.0 mmHg) at the end of 10 years. CONCLUSION: Approximately two thirds of patients will still be under care 10 years after presentation. In older, white patients with glaucoma the overall goal of preventing visual handicap is achievable for most patients 10 years after diagnosis.