Minimising bias in an un-masked, pragmatic rct comparing two treatment pathways for glaucoma by the use of decision support software - the light trial experience

ragmatic trials of treatment pathways can require patient awareness of treatment allocation in order to better represent clinical reality, for example when concordance with a treatment has an important effect on outcome. Conversely, masking of treating clinicians to allocation group can be impossible when full clinical assessment requires knowledge of the current treatments, resources do not permit separate teams for treatment and assessment or when such duplication of clinician contact might affect an outcome such as patient experience. The LiGHT trial is a 718 subject multi-centre 6-year NIHR-funded study of two treatment pathways for glaucoma with outcome measures of health related quality of life and cost effectiveness. We aimed to minimise variation in aspects of clinical behaviour that might introduce bias by affecting either of these outcomes

Longevity of Anterior Composite Restorations for Localized Tooth Wear: A Scoping Review

(1) Objective: This scoping review evaluates composite restorations as a treatment modality for anterior tooth surface loss and investigates the longevity of the direct and indirect composites used herein. / (2) Method: The search encompassed Medline, Embase, Web of Science, the Cochrane Library, and hand search utilizing the PICO framework. / (3) Results: Eight studies were included in this review, comprising one randomized controlled trial, one retrospective, and six prospective studies. Some studies reported favorable outcomes for composite restorations in anterior teeth. Although not statistically significant, evidence supported the anterior composite as a viable short- to medium-term solution for managing tooth wear. Direct resin composites were deemed clinically and cost-effective when managing localized anterior tooth wear. However, limitations and inconsistencies in this scoping review limited definitive clinical recommendations. / (4) Conclusions: Further research, including well-managed randomized controlled trials using standardized protocols and longer follow-up periods, is essential to reconfirm the long-term efficacies of anterior composite restorations when managing tooth wear. A robust research design and exacting protocols could facilitate more meaningful clinical conclusions

Intraocular pressure and diurnal fluctuation of open-angle glaucoma and ocular hypertension: a baseline report from the LiGHT China trial cohort

AIMS: To report the baseline intraocular pressure (IOP) characteristics and its diurnal fluctuation in the Laser in Glaucoma and Ocular Hypertension China cohort. METHODS: 622 primary open-angle glaucoma (POAG) patients and 149 ocular hypertension (OHT) patients were recruited at Zhongshan Ophthalmic Center from 2015 to 2019. Standardised ocular examinations were performed including IOP measurement using the Goldmann applanation tonometer. Daytime phasing IOP was recorded at 8:00, 10:00, 11:30, 14:30, 17:00 hour. RESULTS: The mean baseline IOP was 20.2 mm Hg for POAG patients and 24.4 mm Hg for OHT. Multiple regression analysis revealed that thicker central corneal thickness (CCT) was correlated with higher IOP in both POAG and OHT. Male gender and younger age were correlated with higher IOP only for POAG. As for diurnal IOP fluctuation, mean IOP fluctuation was 3.4 mm Hg in POAG eyes and 4.4 mm Hg in OHT. The peak and trough IOP occurred at 8:00 and 14:30 hour in both POAG and OHT eyes. CONCLUSIONS: Younger age, male gender and thicker CCT are correlated to higher IOP in POAG patients while only thicker CCT is related to higher IOP in OHT patients. Peak IOP appears mostly at early morning or late afternoon and trough value occurs mostly at early afternoon

Laser in Glaucoma and Ocular Hypertension Trial (LIGHT) in China - A Randomized Controlled Trial: Design and Baseline Characteristics

PURPOSE: To describe the baseline characteristics of a trial to evaluate whether selective laser trabeculoplasty (SLT), as a first-line treatment, provides superior economic and health-related quality of life outcomes to medical treatment in China. DESIGN: The LiGHT China trial is an unmasked, single-center, pragmatic, randomized controlled trial. METHODS: A total of 771 previously undiagnosed patients with primary open angle glaucoma (POAG, 622 patients) or ocular hypertension (OHT, 149 patients) at Zhongshan Ophthalmic Center were recruited from March 2015 to January 2019. Subjects were randomized to SLT-1st (followed by medication then surgery when required) or Medicine-1st (medication followed by surgery when required). The primary outcome was health-related quality of life (HRQL). The secondary outcomes were clinical outcomes, cost, cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, visual function, and safety. RESULTS: The mean age of POAG patients was 49.8 years and 38.8 years for OHT. The median intraocular pressure was 20 mm Hg for the 1,105 POAG eyes and 24 mm Hg for the 271 OHT eyes. POAG eyes had thinner central cornea thickness (CCT, 536 µm) than OHT eyes (545 µm). Median mean deviation of the visual field in POAG eyes was -4.2 dB. Median refractive error was -1.5 D for OHT eyes and -1.25 D for POAG eyes. There was no difference between POAG and OHT patients on baseline scores of GUI, GSS and VF-14. The difference between OHT and POAG on the EQ-5D-5L was 0.024. CONCLUSIONS: Compared with participants in the LiGHT UK trial, participants in this trial were younger, more myopic and had more severe visual field defects

LiGHT trial: 6-year results of primary selective laser trabeculoplasty versus eye drops for the treatment of glaucoma and ocular hypertension

PURPOSE: The LiGHT trial has shown selective laser trabeculoplasty (SLT) to be clinically and cost-effective as a primary treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT) at 3 years. This paper reports health-related quality of life (HRQL) and clinical effectiveness of initial treatment with SLT compared to intra-ocular pressure (IOP) lowering eye drops, after 6 years of treatment. DESIGN: Prospective multicentre randomized controlled trial. PARTICIPANTS: Treatment-naïve eyes with OAG or OHT, initially treated with SLT or IOP-lowering drops. METHODS: Patients were randomly allocated to initial SLT or eye drops. Eye specific target IOP and monitoring intervals were based on international guidelines. After the initial 3 years of the trial, patients in the SLT arm were permitted a 3rd SLT if necessary; patients in the drops arm were allowed SLT as a treatment switch or escalation. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223). MAIN OUTCOME MEASURES: The primary outcome was HRQL at 6 years; secondary outcomes were clinical effectiveness and safety. RESULTS: Of the 692 patients completing 3 years in the LiGHT trial, 633 (91.5%) entered the extension and 524 patients completed 6 years in the trial (82.8% of those entering the extension phase, 73% of those initially randomised). At 6 years, there were no significant differences in HRQL for EQ-5D, GUI and GQL-15 (all p>0.05). The SLT arm had better GSS scores than the drops arm (83.6 (SD 18.1) vs 81.3 (SD 17.3), respectively). 69.8% of eyes in the SLT arm remained at or below target IOP without the need for medical or surgical treatment. More eyes in the drops arm exhibited disease progression (26.8% vs 19.6%, respectively, p=0.006). Trabeculectomy was required in 32 eyes in the drops arm compared to 13 eyes in the SLT arm (p<0.001); there were more cataract surgeries in the drops arm (95 compared to 57 eyes, p=0.03). There were no serious laser-related adverse events. CONCLUSIONS: SLT is a safe treatment for OAG and OHT, providing better long-term disease control than initial drop therapy, with reduced need for incisional glaucoma and cataract surgery over 6 years

Primary Selective Laser Trabeculoplasty for Open-Angle Glaucoma and Ocular Hypertension: Clinical Outcomes, Predictors of Success, and Safety from the Laser in Glaucoma and Ocular Hypertension Trial.

PURPOSE: To report clinical efficacy, predictors of success, and safety of primary selective laser trabeculoplasty (SLT) used in treatment-naive patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). DESIGN: Post hoc analysis of a multicenter, prospective, randomized, controlled trial. PARTICIPANTS: Treatment-naive patients with OAG or OHT. METHODS: Patients randomized to SLT or topical medication and treated to predefined target intraocular pressures (IOPs) requiring ≥20% IOP reduction from baseline for all disease severity levels. OUTCOME MEASURES: Initial (early) absolute IOP-lowering at 2 months. Achievement of drop-free disease-control: meeting target IOP without disease progression or need for additional topical medication over 36 months after SLT. Predictors of early absolute IOP-lowering and drop-free disease-control after single initial SLT. Frequency of laser-related complications. RESULTS: A total of 611 eyes (195 OHT and 416 OAG) of 355 patients received SLT, and 622 eyes (185 OHT and 437 OAG) of 362 patients received topical medication at baseline. Early absolute IOP-lowering after SLT was no different between OHT and OAG eyes (adjusted mean difference = -0.05 mmHg; 95% confidence interval [CI], -0.6 to 0.5 mmHg; P = 0.85). No difference was noted in early absolute IOP-lowering between topical medication and primary SLT (adjusted mean difference = -0.1 mmHg; 95% CI, -0.6 to 0.4 mmHg; P = 0.67). Early absolute IOP-lowering with primary SLT was positively associated with baseline IOP (coefficient 0.58; 95% CI, 0.53-0.63; P 5 mmHg from pretreatment IOP) with 1 eye requiring treatment. CONCLUSIONS: Primary SLT achieved comparable early absolute IOP-lowering in OHT versus OAG eyes. Drop-free disease-control was achieved in approximately 75% eyes at 36 months after 1 or 2 SLTs, the majority of these after single SLT. These analyses are exploratory but support primary SLT to be effective and safe in treatment-naive OAG and OHT eyes

The effect of induced intraocular straylight on perimetric tests

Purpose. To investigate the effect of intraocular straylight (IOS) on threshold measurements made by four types of perimetry: standard automated perimetry (SAP), frequency-doubling technology (FDT) perimetry, flicker-defined form (FDF) perimetry, and the Moorfields Motion Displacement Test (MDT). Methods. Six healthy young (21–29 years) psychophysically experienced observers were tested five times with each perimeter, each time with one of five different white opacity filters (WOFs), to induce various levels of IOS. Each WOF gave rise to an increase in IOS, measured with a straylight meter, of between 10% and 200% from baseline and ranging in effect from normal ageing to significant cataract. The change in sensitivity from baseline was normalized, allowing comparison of standardized (z) scores (change divided by the standard deviation of normative values) for each instrument. Results. Average SAP, FDT, and FDF thresholds were significantly affected (P < 0.001) by moderate to large increases in IOS (50%–200%), whereas MDT remained largely unaffected over the same range of straylight levels. Conclusions. The Moorfields MDT shows greater resilience to the effects of additional straylight compared with SAP, FDT, or FDF

Visual Field Outcomes from the Multicenter, Randomized Controlled Laser in Glaucoma and Ocular Hypertension Trial

© 2020 American Academy of Ophthalmology Purpose: To compare visual field outcomes of ocular hypertensive and glaucoma patients treated first with medical therapy with those treated first with selective laser trabeculoplasty (SLT). Design: Secondary analysis of patients from the Laser in Glaucoma and Ocular Hypertension study, a multicenter randomized controlled trial. Participants: Three hundred forty-four patients (588 eyes) treated first with medical therapy and 344 patients (590 eyes) treated first with SLT. Methods: Visual fields (VFs) were measured using standard automated perimetry and arranged in series (median length and duration, 9 VFs over 48 months). Hierarchical linear models were used to estimate pointwise VF progression rates, which were then averaged to produce a global progression estimate for each eye. Proportions of points and patients in each treatment group with fast (<–1 dB/year) or moderate (<–0.5 dB/year) progression were compared using log-binomial regression. Main Outcome Measures: Pointwise and global progression rates of total deviation (TD) and pattern deviation (PD). Results: A greater proportion of eyes underwent moderate or fast TD progression in the medical therapy group compared with the SLT group (26.2% vs. 16.9%; risk ratio [RR], 1.55; 95% confidence interval [CI], 1.23–1.93; P < 0.001). A similar pattern was observed for pointwise rates (medical therapy, 26.1% vs. SLT, 19.0%; RR, 1.37; 95% CI, 1.33–1.42; P < 0.001). A greater proportion of pointwise PD rates were categorized as moderate or fast in the medical therapy group (medical therapy, 11.5% vs. SLT, 8.3%; RR, 1.39; 95% CI, 1.32–1.46; P < 0.001). No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928). Conclusions: A slightly larger proportion of ocular hypertensive and glaucoma patients treated first with medical therapy underwent rapid VF progression compared with those treated first with SLT

A Scoping Review of Marginal and Internal Fit Accuracy of Lithium Disilicate Restorations

Objective: To assess and compare the accuracy of the marginal and internal fit of lithium disilicate crowns and onlays fabricated by conventional and digital methods. Sources: An electronic search was carried out on MEDLINE, Embase, Web of Science and Cochrane Library between 2010 and 2021. Study selection: Seventeen studies published between 2014 &amp; 2021 were included, of which thirteen were in vitro laboratory-based studies; three were in vivo clinical studies and one randomised controlled trial. Data: Twelve studies focused on the marginal fit, five focused on the marginal and internal fit. Five studies found that the marginal and internal fit of crowns were more accurate using digital techniques. Five studies noted that there was no difference using either technique and two noted that conventional methods had a more accurate marginal fit. Conclusion: Digital techniques were comparable to conventional methods in terms of accuracy although there was insufficient evidence to indicate that one technique was more accurate than the other with respect to Lithium Disilicate restorations. Clinical significance: Digital impressions are reliable and viable alternatives for clinicians compared to conventional impression techniques when restoring teeth with lithium disilicate restorations