Selective laser trabeculoplasty versus topical medication as initial glaucoma treatment: the glaucoma initial treatment study randomised clinical trial

2019 ◽  
Vol 104 (6) ◽  
pp. 813-821 ◽  
Author(s):  
Ghee Soon Ang ◽  
Eva K Fenwick ◽  
Marios Constantinou ◽  
Alfred Tau Liang Gan ◽  
Ryan Eyn Kidd Man ◽  
...  
Keyword(s):  
Assessment Tool ◽  
Controlled Trial ◽  
Well Being ◽  
Randomised Clinical Trial ◽  
Absolute Difference ◽  
Selective Laser Trabeculoplasty ◽  
Topical Medication ◽  
Intention To Treat ◽  
Conjunctival Hyperaemia ◽  
Laser Trabeculoplasty

Background/AimsTo determine if selective laser trabeculoplasty (SLT) is superior to topical medication as a first-line treatment for glaucoma on quality of life (QoL) and clinical outcomes.MethodsIn this international, longitudinal, multisite randomised controlled trial, treatment naïve mild-to-moderate primary open angle or exfoliation glaucoma patients were randomised 1:1 to SLT or topical medication. Glaucoma-specific QoL (primary outcome) was measured using the Glaucoma Outcomes Assessment Tool (GOAT; 342 items, 12 domains). Secondary outcomes included rate of successful intraocular pressure (IOP) reduction (>25% reduction from baseline) and presence of ocular surface disease including conjunctival hyperaemia and eyelid erythema. Our intention-to-treat analysis was performed at months 12 and 24.ResultsOf 167 enrolled patients, 83 and 84 were randomised to SLT and topical medication, respectively; and 145 (n=75 SLT, n=70 medication) completed 24-month follow-up. While both treatment arms achieved significant within-group gains in GOAT outcomes at both endpoints, SLT patients reported a greater between-group improvement in ‘social well-being’ compared with medication patients (mean±SE=0.28±0.13; p=0.034) at 24 months. At month 24, the rate of successful IOP reduction was 18.6% (95% CI 3.0% to 34.3%, p=0.022) higher (absolute difference) in the medication compared with SLT group. More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.ConclusionOverall, we did not find evidence that SLT was superior to medication in improving glaucoma-specific QoL. While we found superior IOP reduction in the medication arm, eyelid erythema and conjunctival hyperaemia were more prevalent in these patients compared with the SLT group.Trial registrationACTRN12611000720910.

Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty

2021 ◽  
pp. 112067212110183
Author(s):  
Evelyn Tran ◽  
Carina Sanvicente ◽  
Lisa A Hark ◽  
Jonathan S Myers ◽  
Qiang Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Selective Laser Trabeculoplasty ◽  
First Line ◽  
Randomized Controlled ◽  
Laser Trabeculoplasty ◽  
Glaucoma Treatment

Purpose: To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. Methods: This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Results: Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects ( p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82–0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT ( p = 0.08) and 50% scheduled an SLT appointment after intervention ( p = 0.005). Conclusions: A slideshow and video-based educational intervention may positively enhance patient adoption of SLT. Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778

scholarly journals Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

2021 ◽  
Vol 18 (7) ◽  
pp. 3689
Author(s):  
Tzofnat Zadok-Gurman ◽  
Ronit Jakobovich ◽  
Eti Dvash ◽  
Keren Zafrani ◽  
Benjamin Rolnik ◽  
...  
Keyword(s):  
Stress Reduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Stressful Events ◽  
Control Group ◽  
Subjective Well Being ◽  
Intention To Treat ◽  
School Year ◽  
Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

scholarly journals Social Volunteering in Aging Adults Increases Regions of the Amygdala and Correlates With Enhanced Generativity

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 795-795
Author(s):  
Michelle Carlson
Keyword(s):  
Social Engagement ◽  
Controlled Trial ◽  
Well Being ◽  
Health Study ◽  
Brain Health ◽  
Volunteer Program ◽  
Intention To Treat ◽  
Intervention Impact ◽  
Aging Adults ◽  
The Brain

Abstract The Brain Health Study (BHS) of the Baltimore Experience Corps Trial (BECT) examined whether a randomized, controlled trial of an intergenerational social volunteer program, entitled Experience Corps, increased subregions of the amygdala related to socioemotional memory and risk for Alzheimer’s disease in aging adults. We further assessed functional correlates of these intervention-related changes and changes in aging adults’ developmental need to be generative, or, to give back to the well-being of others. The BHS simultaneously randomized 112 men and women (59 intervention; 53 control) within BECT to evaluate intervention impact on biomarkers of brain health at baseline and annual follow-ups during the two-year trial. Intention-to-treat analyses revealed program-specific increases in the shape of the centromedial and basomedial regions of the left amygdala (p’s≤0.05 adjusted), which were correlated with increases in generativity (p’s =0.06). Meaningful social engagement buffered amygdalar declines important to preservation of emotionally salient memory and risk for dementia. Part of a symposium sponsored by Brain Interest Group.

scholarly journals The Effectiveness of a Community-Based Mentoring Program for Children Aged 5–11 Years: Results from a Randomized Controlled Trial

2020 ◽  
Vol 22 (1) ◽  
pp. 100-112 ◽  
Author(s):  
Nick Axford ◽  
Gretchen Bjornstad ◽  
Justin Matthews ◽  
Laura Whybra ◽  
Vashti Berry ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Causal Effect ◽  
Controlled Trial ◽  
Well Being ◽  
Mentoring Program ◽  
Post Intervention ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Average Causal Effect ◽  
Superiority Trial

AbstractThe study, a two-arm, randomized controlled, parallel group, superiority trial, aimed to evaluate the implementation and effectiveness of a 12-month one-to-one volunteer mentoring program designed to improve behavioral and emotional outcomes in children aged 5 to 11 years who have teacher- and parent/carer-reported behavioral difficulties. Participants were 246 children (123 intervention, 123 control; mean age 8.4 years; 87% boys) in five sites in London, UK, scoring in the “abnormal” range on the teacher-rated Strengths and Difficulties Questionnaire (SDQ) Total Difficulties measure and in the “borderline” or abnormal range on the parent-rated SDQ Total Difficulties measure. Randomization on a 1:1 ratio took place using a computer-generated sequence and stratifying by site. Data collectors and statisticians were blind to participant allocation status. Outcome measures focused on parent- and teacher-rated child behavior and emotions, and child-rated self-perception and hope. Intention-to-treat analysis on all 246 randomized participants (using imputed data where necessary) showed that at post-intervention (16 months after randomization), there were no statistically significant effects on the primary outcome—parent-rated SDQ Total Difficulties (adjusted standardized mean difference = − 0.12; 95% CI: −0.38 to 0.13; p = 0.33)—or any secondary outcomes. Results from complier average causal effect (CACE) analysis using the primary outcome indicated the intervention was not effective for children who received the recommended duration of mentoring. Exploratory analyses found no sub-group effects on the primary outcome. The article concludes that the mentoring program had no effect on children’s behavior or emotional well-being, and that program content needs revising to satisfactorily address key risk and protective factors.

scholarly journals Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e036327 ◽  
Author(s):  
Belay Bayissasse ◽  
Kristin M Sullivan ◽  
Shannath L Merbs ◽  
Beatriz Munoz ◽  
Alexander Keil ◽  
...  
Keyword(s):  
Surgical Outcomes ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Upper Eyelid ◽  
Intention To Treat ◽  
Research Ethics Review ◽  
Registration Number ◽  
Randomised Controlled ◽  
The Impact ◽  
Trachomatous Trichiasis

IntroductionTrachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes.Methods and analysisMaximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach.Ethics and disseminationThe University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals.Trial registration numberNCT03100747.

scholarly journals A Web-Based Photo-Alteration Intervention to Promote Sleep: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Isabel Perucho ◽  
Kamalakannan M Vijayakumar ◽  
Sean N Talamas ◽  
Michael Wei-Liang Chee ◽  
David I Perrett ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Duration ◽  
Controlled Trial ◽  
Well Being ◽  
Sleep Hygiene ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Information Group ◽  
Function Of Sleep

BACKGROUND Receiving insufficient sleep has wide-ranging consequences for health and well-being. Although educational programs have been developed to promote sleep, these have had limited success in extending sleep duration. To address this gap, we developed a Web-based program emphasizing how physical appearances change with varying amounts of sleep. OBJECTIVE The aims of this study were to evaluate (1) whether participants can detect changes in appearances as a function of sleep and (2) whether this intervention can alter habitual sleep patterns. METHODS We conducted a 5-week, parallel-group, randomized controlled trial among 70 habitual short sleepers (healthy adults who reported having &lt;7 hours of sleep routinely). Upon study enrollment, participants were randomly assigned (1:1) to receive either standard information or an appearance-based intervention. Both groups received educational materials about sleep, but those in the appearance group also viewed a website containing digitally edited photographs that showed how they would look with varying amounts of sleep. As the outcome variables, sleep duration was monitored objectively via actigraphy (at baseline and at postintervention weeks 1 and 4), and participants completed a measure of sleep hygiene (at baseline and at postintervention weeks 2, 4, and 5). For each outcome, we ran intention-to-treat analyses using linear mixed-effects models. RESULTS In total, 35 participants were assigned to each group. Validating the intervention, participants in the appearance group (1) were able to identify what they looked like at baseline and (2) judged that they would look more attractive with a longer sleep duration (<italic>t</italic><sub>26</sub>=10.35, <italic>P</italic>&lt;.001). In turn, this translated to changes in sleep hygiene. Whereas participants in the appearance group showed improvements following the intervention (<italic>F</italic><sub>1,107.99</sub>=9.05, <italic>P</italic>=.003), those in the information group did not (<italic>F</italic><sub>1,84.7</sub>=0.19, <italic>P</italic>=.66). Finally, there was no significant effect of group nor interaction of group and time on actigraphy-measured sleep duration (smallest <italic>P</italic>=.26). CONCLUSIONS Our findings suggest that an appearance-based intervention, while not sufficient as a stand-alone, could have an adjunctive role in sleep promotion. CLINICALTRIAL ClinicalTrials.gov NCT02491138; https://clinicaltrials.gov/ct2/show/study/NCT02491138.

Laser eye procedure is safe and effective as an early treatment for glaucoma

BMJ ◽  
2019 ◽  
pp. l4235
Author(s):  
Rob Cook ◽  
Vaughan Thomas ◽  
Rosie Martin
Keyword(s):  
Controlled Trial ◽  
Health Technology ◽  
Eye Drops ◽  
Selective Laser Trabeculoplasty ◽  
First Line ◽  
Early Glaucoma ◽  
Link Type ◽  
Laser Trabeculoplasty ◽  
Health Technology Assessment Programme ◽  
Randomised Controlled

The studyGazzard G, Konstantakopoulou G, Garway-Heath E, et al. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet 2019; doi:10.1016/S0140-6736(18)32213-X.This project was funded by the NIHR Health Technology Assessment Programme (project number 09/104/40) and was sponsored by the Moorfields Eye Hospital NHS Foundation Trust.To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000774/early-glaucoma-laser-eye-treatment-trabeculoplasty

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