Anti-inflammatory therapy after selective laser trabeculoplasty: a randomized, double-masked, placebo-controlled clinical trial.

PURPOSE: To investigate the effect of anti-inflammatory therapy on selective laser trabeculoplasty (SLT) outcomes. DESIGN: Randomized, double-masked, placebo-controlled trial. PARTICIPANTS: Patients with primary open-angle or pseudo-exfoliation glaucoma. METHODS: Patients undergoing SLT were randomized to receive placebo (artificial tears), prednisolone acetate 1%, or ketorolac tromethamine 0.5% eye drops 4 times per day for 5 days commencing immediately after SLT. MAIN OUTCOME MEASURES: Change in intraocular pressure (IOP) from baseline to the 1-month post-SLT visit. RESULTS: Mean change in IOP at the 1-month primary outcome time point, as well as all other time points, was not significantly different among groups (P = 0.99). Likewise, a repeated-measures, mixed-effects model did not find significant differences in IOP outcome at the 1-month time point (P = 0.95). The IOP was reduced in all groups at the 1-month post-SLT time point and all other time points, and no significant differences were found between groups using separate unadjusted cross-sectional analyses of variance (P > 0.15 for analyses at all time points). Treatment failure rates were not different among groups (P = 0.75), and at 1 year after SLT, the percentage of patients maintaining a 20% IOP reduction ranged from 18% to 22% in the 3 study groups. CONCLUSIONS: Anti-inflammatory therapy after SLT does not seem to substantially influence the IOP-lowering effect of SLT. In this study of patients with low baseline IOP, SLT showed limited efficacy in achieving a sustained reduction in IOP.

Do findings on routine examination identify patients at risk for primary open-angle glaucoma? The rational clinical examination systematic review.

IMPORTANCE: Glaucoma is the second leading cause of blindness worldwide, and its insidious onset is often associated with diagnostic delay. Since glaucoma progression can often be effectively diminished when treated, identifying individuals at risk for glaucoma could potentially lead to earlier detection and prevent associated vision loss. OBJECTIVE: To quantify the diagnostic accuracy of examination findings and relevant risk factors in identifying individuals with primary open-angle glaucoma (POAG), the most common form of glaucoma in North America. DATA SOURCES: Structured Medline (January 1950-January 2013) search and a hand search of references and citations of retrieved articles yielding 57 articles from 41 studies. STUDY SELECTION: Population-based studies of high-level methods relating relevant examination findings of cup-to-disc ratio (CDR), CDR asymmetry, intraocular pressure (IOP), and demographic risk factors to the presence of POAG. RESULTS: The summary prevalence of glaucoma in the highest-quality studies was 2.6% (95% CI, 2.1%-3.1%). Among risk factors evaluated, high myopia (≥6 diopters; odds ratio [OR], 5.7; 95% CI, 3.1-11) and family history (OR, 3.3; 95% CI, 2.0-5.6) had the strongest association with glaucoma. Black race (OR, 2.9; 95% CI, 1.4-5.9) and increasing age (especially age >80 years; OR, 2.9; 95% CI, 1.9-4.3) were also associated with an increased risk. As CDR increased, the likelihood for POAG increased with a likelihood ratio (LR) of 14 (95% CI, 5.3-39) for CDR of 0.7 or greater. Increasing CDR asymmetry was also associated with an increased likelihood for POAG (CDR asymmetry ≥0.3; LR, 7.3; 95% CI, 3.3-16). No single threshold for CDR or asymmetry ruled out glaucoma. The presence of a disc hemorrhage (LR, 12; 95% CI, 2.9-48) was highly suggestive of glaucoma, but the absence of a hemorrhage was nondiagnostic (LR, 0.94; 95% CI, 0.83-0.98). At the commonly used cutoff for high IOP (≥22), the LR was 13 (95% CI, 8.2-17), while lower IOP made glaucoma less likely (LR, 0.65; 95% CI, 0.55-0.76). We found no studies of screening examinations performed by generalist physicians in a routine setting. CONCLUSIONS AND RELEVANCE: Individual findings of increased CDR, CDR asymmetry, disc hemorrhage, and elevated IOP, as well as demographic risk factors of family history, black race, and advanced age are associated with increased risk for POAG, but their absence does not effectively rule out POAG. The best available data support examination by an ophthalmologist as the most accurate way to detect glaucoma.

Surgeon Experience as a Risk Factor for Short-Term Failure for Ab Interno Gelatin Microstent: A Canadian Multicenter Propensity-Matched Study.

PURPOSE: To compare the efficacy and safety of early versus later ab interno gelatin microstent placement with mitomycin C. DESIGN: Canada-wide, multicenter, retrospective propensity score-matched cohort study. PARTICIPANTS: Two hundred seventy eyes (135 early cases and 135 later cases) with no prior incisional surgery. METHODS: Surgeons' first 20 patients (early cases group), from 6 glaucoma surgeons across 4 Canadian sites, were matched 1:1 to patients with the closest propensity score from the later (21+) patients (later cases group). MAIN OUTCOME MEASURES: Primary outcome was hazard ratio (HR) of failure of the early versus later cases groups, with failure defined as IOP of less than 6 mmHg with more than 2 lines of vision loss or more than 17 mmHg with no medications (complete success) on 2 consecutive visits despite in-clinic maneuvers (including needling) more than 1 month after surgery. Secondary outcomes were HRs for failure, defined as IOP outside the range of 6 to 14 mmHg and 6 to 21 mmHg with and without allowing for medications (qualified success), interventions, complications, and reoperations. RESULTS: Hazard ratio of failure for early versus later cases groups was 1.38 (95% confidence interval [CI], 0.97-1.96) for the IOP range of 6 to 17 mmHg, 1.29 (95% CI, 0.90-1.84) for 6 to 14 mmHg, and 1.48 (95% CI, 1.03-2.13) for 6 to 21 mmHg without medication and 0.95 (95% CI, 0.55-1.64), 0.95 (95% CI, 0.61-1.48), and 0.95 (95% CI, 0.52-1.75) for the same IOP ranges allowing for medications. Needling rates were 43.0% (early cases group) and 41.5% (later cases group). Complication rates after 1 month occurred in 9.6% (early cases group) and 11.1% (later cases group; P = 0.69). Reoperation rates were 14.8% (early cases group) and 8.1% (later cases group; P = 0.08). CONCLUSIONS: There is some evidence for improved success in the later cases group. Similar needling rates, similar complication rates, and a slightly higher reoperation rate were found for the early cases group. The results suggest that this procedure can be adopted by existing surgeons with current training regimens, although they may see an improvement in their success outcomes over time.

Comparison of trabeculectomy versus Ex-PRESS: 3-year follow-up.

AIMS: To compare the outcomes of Ex-PRESS versus trabeculectomy at 3 years. METHODS: Consenting patients aged 18-85 years with medically uncontrolled open-angle glaucoma scheduled for trabeculectomy were included in this study. 63 subjects were randomised to undergo Ex-PRESS (32) or trabeculectomy (31). Follow-up data included intraocular pressure (IOP), glaucoma medications, visual acuity (VA), complications and additional interventions. Complete success was defined as IOP between 5 and 18 mm Hg and 20% reduction from baseline without glaucoma medications, while qualified success was with or without glaucoma medications. RESULTS: Complete success at 2 and 3 years was 43% vs 42% (p=0.78) and 35% vs 38% (p=0.92) in Ex-PRESS versus trabeculectomy, respectively. Qualified success at 2 and 3 years was 59% vs 76% (p=0.20) and 52% vs 61% (p=0.43) in Ex-PRESS versus trabeculectomy, respectively. Mean IOP at 2 and 3 years was 12.5±5.1 mm Hg vs 10.3±3.7 mm Hg (p=0.07) and 13.3±4.5 mm Hg vs 11.1±4.4 mm Hg (p=0.10) for Ex-PRESS versus trabeculectomy, respectively. At 3 years, 47.6% of Ex-PRESS and 50% of trabeculectomy patients were on glaucoma medications (p=1.00). No difference in VA was found after 3 years (logarithm of minimum angle of resolution 0.43±0.4 vs 0.72±0.8 for Ex-PRESS vs trabeculectomy, p=0.11). When excluding patients who underwent reoperation VA was better in the Ex-PRESS group at 1, 2 and 3 years. There were no complications after the first year in either group. CONCLUSIONS: We found no difference in success rates, mean IOP or other secondary outcomes between Ex-PRESS and trabeculectomy after 3 years of follow-up. TRIAL REGISTRATION NUMBER: NCT01263561; post results.

Medical Management of Glaucoma in the 21st Century from a Canadian Perspective.

Glaucoma is a medical term describing a group of progressive optic neuropathies characterized by degeneration of retinal ganglion cells and retinal nerve fibre layer and resulting in changes in the optic nerve head. Glaucoma is a leading cause of irreversible vision loss worldwide. With the aging population it is expected that the prevalence of glaucoma will continue to increase. Despite recent advances in imaging and visual field testing techniques that allow establishment of earlier diagnosis and treatment initiation, significant numbers of glaucoma patients are undiagnosed and present late in the course of their disease. This can lead to irreversible vision loss, reduced quality of life, and a higher socioeconomic burden. Selection of therapeutic approaches for glaucoma should be based on careful ocular examination, patient medical history, presence of comorbidities, and awareness of concomitant systemic therapies. Therapy should also be individualized to patients' needs and preferences. Recent developments in this therapeutic field require revisiting treatment algorithms and integration of traditional and novel approaches in order to ensure optimal visual outcomes. This article provides an overview of recent developments and practice trends in the medical management of glaucoma in Canada. A discussion of the surgical management is beyond the scope of this paper.

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy: 1-Year Results.

PURPOSE: To compare the efficacy and safety of the Ex-PRESS glaucoma shunt with standard trabeculectomy. PATIENTS AND METHODS: Consenting patients with medically uncontrolled open-angle glaucoma were prospectively randomized to trabeculectomy or Ex-PRESS shunt both with mitomycin-C. Exclusion criteria included previous ocular surgery with the exception of clear cornea phaco or 1 previous trabeculectomy, uveitis, and vitreous in the anterior chamber. Standardized data collection sheets were completed at baseline and postoperative day 1, weeks 1 and 2, and months 1, 2, 3, 6, and 12. Primary outcome was intraocular pressure (IOP). Complete success was defined as an IOP between 5 and 18 mm Hg and a 20% reduction from baseline without medication. A sample size calculation determined that 52 eyes were required to detect a 2.0 mm Hg IOP difference with a power of 80%. RESULTS: Sixty-four subjects were enrolled, 33 in the Ex-PRESS and 31 in the trabeculectomy group. IOP was not statistically significantly different between groups. Baseline and 1-year mean IOP was 22.0±6.8 versus 22.7±10.3 mm Hg (P=0.76) and 11.6±4.5 versus 11.3±4.5 mm Hg (P=0.81) in the trabeculectomy versus Ex-PRESS groups, respectively. Complete success was 57% versus 70% (P=0.28) in the trabeculectomy versus Ex-PRESS groups, respectively. There were no statistically significant differences in surgical time, number of glaucoma medications, visual acuity, central corneal thickness, endothelial cell counts, complications, interventions, or bleb morphology between the trabeculectomy and the Ex-PRESS groups. CONCLUSIONS: There was no statistically significant difference between the trabeculectomy and Ex-PRESS groups regarding IOP, success rates, complications, additional interventions, and bleb morphology.

Comparison of visual recovery following ex-PRESS versus trabeculectomy: results of a prospective randomized controlled trial.

PURPOSE: To compare the rate of visual recovery after Ex-PRESS implantation versus standard trabeculectomy. PATIENTS AND METHODS: Subjects enrolled in a prospective randomized controlled trial comparing Ex-PRESS to trabeculectomy were analyzed for postoperative changes in visual acuity (VA). Risk factors for visual loss (split fixation, cup-disc ratio, intraocular pressure, visual field mean deviation, and hypotony) were evaluated. RESULTS: Sixty-four subjects were enrolled (33 Ex-PRESS, 31 trabeculectomy). There was no significant difference in mean logMAR VA between groups at baseline or any study visit. VA was significantly reduced up to week 2 following surgery in both the groups. However, by month 1, VA in the Ex-PRESS group was no longer significantly different from baseline (P=0.23) and remained nonsignificant at subsequent visits up to 6 months. In the trabeculectomy group, VA remained significantly lower than baseline at each study visit. At 6 months, 47% of the trabeculectomy eyes compared with 16% of the Ex-PRESS eyes had lost ≥2 Snellen lines (P=0.01). Reasons for VA loss included cataract, central retinal vein occlusion, and diabetic retinopathy, however, in a significant number of cases no cause could be determined. None of the risk factors evaluated were associated with vision loss. CONCLUSIONS: Although there was no difference in mean VA between the Ex-PRESS and trabeculectomy groups at any time point, trabeculectomy eyes were more likely to lose ≥2 Snellen lines. In addition, VA recovered faster in the Ex-PRESS group.

Career satisfaction and surgical practice patterns among female ophthalmologists.

PURPOSE: To identify gender differences in career satisfaction and practice patterns among Ontario ophthalmologists. METHODS: Survey mailed to all Ontario female ophthalmologists (n = 65) and a random sample of male ophthalmologists (n = 72). RESULTS: Men reported performing more operations per month (p = 0.039) and more operations in the last typical year (p = 0.003). More men than women were doing laser refractive surgery (p = 0.004). There were no gender differences in the proportion performing eye surgery or in the hours worked per week or weeks worked per year. Women reported being primarily responsible for their children for significantly more hours per week than men (p = 0.0003). There were no gender differences in any of the parameters of career satisfaction evaluated: number of hours worked, number of hours in the operating room (OR), balance with personal life, flexibility of work schedules, ability to structure work, relationship with colleagues and relationship with OR staff. INTERPRETATION: Despite spending significantly more hours as the primary supervisor of their children, female ophthalmologists were maintaining the same work week as their male colleagues and reported equal career satisfaction. Further investigation is needed to explore the differences between male and female ophthalmologists in the reported number of operations performed.

Anaesthetic plus dilating gel improves pupil dilation for cataract surgery.

OBJECTIVE: To evaluate the efficacy of a combination anaesthetic plus dilating gel (ADG) on pupil dilation (PD) and corneal anaesthesia (KA) compared to traditional preoperative pharmacotherapy for cataract surgery. DESIGN: Prospective, noninferiority study. METHODS: We studied 20 consenting adults who experienced unilateral cataracts and underwent routine cataract surgery, receiving the traditional preoperative pharmacologic regimen in the operated eye (control eye): diclofenac 0.1%, gentamicin 0.3%, cyclopentolate 1%, phenylephrine 2.5%, and tropicamide 1% 60 and 20 minutes prior to surgery. They then received tetracaine 0.5% and povidone-iodine 5% 10 minutes prior to surgery; and were given tetracaine 0.5%, povidone-iodine 5%, and lidocaine 2% gel 1 minute prior to surgery. Epinephrine 0.1%, 1 cc per 500 mL bag of balanced saline salt solution was administered during surgery. The nonoperated eye (study eye) received tetracaine 0.5%, povidone-iodine 5%, and 0.35 cc ADG gel (phenylephrine 10%, tropicamide 1%, diclofenac 0.1%, and lidocaine 2%) 60 and 10 minutes prior to surgery. PD and KA were measured at baseline, at 30 minutes, and at 5 minutes prior to surgery, and at 5 minutes after surgery. RESULTS: There was no difference in PD (p = 0.2634) or KA (p = 0.6058) between the study eyes and the control eyes at baseline. Preoperatively, greater mydriasis was achieved in the study eye (7.95 ± 0.91 mm vs 7.17 ± 1.25 mm; p < 0.0001). There was no significant difference in preoperative KA between the study and control eyes (1.5 ± 2.2 mm vs 1.4 ± 2.1 mm; p = 0.77). CONCLUSIONS: The combination ADG for preoperative preparation of cataract patients achieves at least equivalent dilation and corneal anaesthesia as the current preoperative pharmacologic regimen.

Brachial plexus neuropathy secondary to postoperative prone positioning for macular hole surgery.

PURPOSE: To report a case of unilateral brachial plexus neuropathy after prone positioning for macular hole repair. METHODS: Case report. RESULTS: After 7 days of strict prone positioning post-macular hole surgery, a 60-year-old patient developed severe pain and weakness in the left arm. Neurologic examination, imaging, and electromyography showed that the patient developed a unilateral brachial plexus neuropathy. Her strength and pain quickly improved after hospitalization and treatment with intravenous solumedrol, pain control, and physiotherapy. Her best-corrected vision improved from 20/400 to 20/40, however, she was left with frozen shoulder syndrome. CONCLUSION: After macular hole surgery, prone positioning with persistent abduction of the shoulder such that the patient's hands rest above the head may put patients at risk for a brachial plexus neuropathy. However, this risk may be minimized by the use of positioning assistive devices, reducing the duration in the prone position, instituting frequent breaks, and warning patients to look for signs of neuropathy.

Evaluation of investigator bias in industry-funded clinical trials of latanoprost.

OBJECTIVE: To determine whether sponsorship of prostaglandin analogue (PGA) clinical trials results in investigator bias in outcomes when studying intraocular pressure (IOP). DESIGN: Retrospective, observational cohort study. METHODS: A PubMed search was performed for latanoprost or Xalatan, bimatoprost or Lumigan, and travoprost or Travatan, with limits to humans, clinical trials, and English language. Inclusion criteria included randomized controlled trials, open-angle glaucoma, monotherapy with a PGA, baseline IOP ≥ 21 mm Hg, washout period, and minimum 1-month follow-up. Each article was reviewed by 2 independent reviewers. The results of IOP for each PGA were categorized as being sponsored by the parent company (the company manufacturing the PGA); by the competing company (the company manufacturing competing glaucoma therapy); or by a nonindustry source. The mean IOP and changes in IOP from baseline were compared among the 3 categories of sponsorship. RESULTS: Only studies involving latanoprost were analyzed because of the low number of studies meeting the inclusion criteria for bimatoprost and travoprost. We found 29 and 13 studies that provided 1- and 3-month data, respectively, for analysis. The mean baseline IOPs in the 3 groups (parent company, competing company, nonindustry) were not significantly different (p = 0.47). The mean IOP at 1 (p = 0.72) and 3 months (p = 0.59) and the change in IOP from baseline (p = 0.83 and 0.90, respectively) were not significantly different in the 3 groups. A random-effects metaregression controlling for the covariates of blinding, naïveté to PGAs, and baseline IOP < 24 mm Hg or ≥ 24 mm Hg did not change the findings. CONCLUSION: There was no evidence of investigator bias in determining outcomes for IOP in these clinical trials of latanoprost.

The Toronto epidemiology glaucoma survey: a pilot study.

OBJECTIVE: To evaluate the prevalence of undetected glaucoma in a Toronto population. DESIGN: A cross-sectional survey. PARTICIPANTS: Toronto residents aged 50 years or older. METHODS: Telephone calls were randomly made to Toronto residents. Those who indicated they did not have glaucoma were invited to the Toronto Western Hospital for a comprehensive ophthalmic assessment, including best corrected visual acuity testing, applanation tonometry, pachymetry, gonioscopy, disc assessment, frequency doubling technology, and Heidelberg retinal tomography. Patient suspected to have glaucoma were asked to return for further evaluation, including a 24-2 Humphrey automated visual field test, repeat Heidelberg retinal tomography, repeat disc assessment, and possibly a diurnal tension curve. The diagnosis of glaucoma was made based on standardized criteria modified from those used by the Rotterdam Study and Foster and associates. RESULTS: Among 975 eligible respondents, 73 (7.5%) stated that they had glaucoma. Of the remaining 902 negative respondents, 271 booked clinical appointments, and 180 completed the clinical assessment; their mean age was 61.6 years. Of the participants, 7 (3.9%) were diagnosed with glaucoma: 5 (2.8%) had primary open-angle glaucoma (3 with low-pressure and 2 with high-pressure glaucoma); 1 had (0.6%) chronic angle-closure glaucoma; and 1 (0.6%) had pseudoexfoliation glaucoma. A further 8 (4.4%) participants were classified as probably having open-angle glaucoma and 33 (18.3%) as being suspected to have glaucoma. Narrow angles were found in 27 participants (15%), and 37 (20.6%) had family histories of glaucoma. CONCLUSION: The prevalence of undetected glaucoma appears to be high in Toronto. Further studies involving larger numbers of participants are required to confirm this finding.