The willingness of patients presenting with advanced glaucoma to participate in a trial comparing primary medical vs primary surgical treatment

Leighton, Paul; Lonsdale, Adam J.; Tildsley, J; King, Anthony J

doi:10.1038/eye.2011.279

Cited by 19 publications

(26 citation statements)

References 31 publications

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“…Descriptive statistics were used to compare demographic characteristics by group (healthy and glaucoma subjects). χ 3 tests were used to compare categorical variables, and t -tests were used to compare continuous variables. Mixed effects models were used to calculate the mean rates of change (slopes) for global cpRNFL thickness, global MRW thickness, and global macular GCIPL thickness loss from baseline.…”

Section: Methodsmentioning

confidence: 99%

“…An estimated 10% to 39% of patients present with advanced glaucoma (OAG), and many are asymptomatic at the time of diagnosis. 1 – 3 Moreover, as the population ages and life expectancy increases, a larger proportion of patients will develop advanced disease. Advanced-OAG patients are, however, at the highest risk of becoming functionally impaired due to the disease and are the costliest to treat.…”

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confidence: 99%

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Structural Change Can Be Detected in Advanced-Glaucoma Eyes

Belghith

Medeiros

Bowd

et al. 2016

Invest. Ophthalmol. Vis. Sci.

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PurposeTo compare spectral-domain optical coherence tomography (SD-OCT) standard structural measures and a new three-dimensional (3D) volume optic nerve head (ONH) change detection method for detecting change over time in severely advanced-glaucoma (open-angle glaucoma [OAG]) patients.MethodsThirty-five eyes of 35 patients with very advanced glaucoma (defined as a visual field mean deviation < −21 dB) and 46 eyes of 30 healthy subjects to estimate aging changes were included. Circumpapillary retinal fiber layer thickness (cpRNFL), minimum rim width (MRW), and macular retinal ganglion cell–inner plexiform layer (GCIPL) thicknesses were measured using the San Diego Automated Layer Segmentation Algorithm (SALSA). Progression was defined as structural loss faster than 95th percentile of healthy eyes. Three-dimensional volume ONH change was estimated using the Bayesian-kernel detection scheme (BKDS), which does not require extensive retinal layer segmentation.ResultsThe number of progressing glaucoma eyes identified was highest for 3D volume BKDS (13, 37%), followed by GCPIL (11, 31%), cpRNFL (4, 11%), and MRW (2, 6%). In advanced-OAG eyes, only the mean rate of GCIPL change reached statistical significance, −0.18 μm/y (P = 0.02); the mean rates of cpRNFL and MRW change were not statistically different from zero. In healthy eyes, the mean rates of cpRNFL, MRW, and GCIPL change were significantly different from zero. (all P < 0.001).ConclusionsGanglion cell–inner plexiform layer and 3D volume BKDS show promise for identifying change in severely advanced glaucoma. These results suggest that structural change can be detected in very advanced disease. Longer follow-up is needed to determine whether changes identified are false positives or true progression.

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Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

Structural Change Can Be Detected in Advanced-Glaucoma Eyes

Belghith

Medeiros

Bowd

et al. 2016

Invest. Ophthalmol. Vis. Sci.

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“…As we hypothesized, patients were less likely to enroll in studies that compared an operative to a non-operative intervention than studies that compared two or more operative interventions, regardless of the country in which the trial was performed. This may be because patients have strong preferences surrounding the irrevocable nature of the decision to undergo surgery and are reluctant to leave this decision to chance [1] , [9] . Alternatively, patients may have a strong preference to undergo a surgical procedure that is the standard of care.…”

Section: Discussionmentioning

confidence: 99%

“…As suggested by several recent trials that have helped shape treatment recommendations for common orthopedic procedures, RCTs are pivotal for investigating the efficacy of surgical procedures or their components [5] , [6] , [7] . It may be challenging to enroll subjects into RCTs that randomly allocate subjects to different types of procedures, since surgery is irrevocable [8] , [9] . Previous studies have identified a number of reasons why an eligible individual may decline to participate in an RCT, such as a preference for one form of therapy over another, difficulty understanding the concept of an RCT, or discomfort with the idea of being randomized [1] , [10] , [11] , [12] , [13] .…”

Section: Introductionmentioning

confidence: 99%

Factors influencing the enrollment in randomized controlled trials in orthopedics

Lim

Roberts

Collins

et al. 2017

Contemporary Clinical Trials Communications

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BackgroundLow enrollment rates are a threat to the external validity of clinical trials. The purpose of this study was to identify factors associated with lower enrollment rates in randomized controlled trials (RCTs) involving orthopedic procedures.MethodsWe performed a search in PubMed/MEDLINE for RCTs that involved any orthopedic surgical procedure, compared different intraoperative interventions, were published in English in a peer-reviewed journal between 2003 and 2014, and reported the numbers of both enrolled and eligible subjects. The primary outcome was the enrollment rate, defined as the number of enrolled subjects divided by the number of eligible subjects. We used a meta-regression to identify factors associated with lower enrollment rates.ResultsThe combined estimate of enrollment rate across all 393 studies meeting inclusion criteria was 90% (95% CI: 89–92%). Trials in North America had significantly lower enrollment rates compared to trials in the rest of the world (80% vs. 92%, p < 0.0001). Trials comparing operative and non-operative treatments had significantly lower enrollment rates than trials comparing two different operative interventions (80% vs. 91%, p < 0.0001). Among trials comparing operative and non-operative interventions, there was a marked difference in enrollment rate by region: 49% in North America and 86% elsewhere (p < 0.0001).ConclusionsRCTs investigating orthopedic procedures have variable enrollment rates depending on their location and the difference between the interventions being studied. North American trials that compare operative and non-operative interventions have the lowest enrollment rates. Investigators planning RCTs would be well advised to consider these data in planning recruitment efforts.

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“…Primary open-angle glaucoma (POAG) is a common clinical eye disease that is irreversible and causes blindness; it is a type of optic neuropathy characterized by the loss of retinal ganglion cells and their axons [1]. An estimated 10% to 39% of patients with POAG present with advanced glaucoma, and many are asymptomatic at the time of diagnosis [2][3][4].…”

Section: Introductionmentioning

confidence: 99%

Trends in the Retinal Nerve Fiber Layer Thickness Changes with Different Degrees of Visual Field Defects

Geng

Wang

Han

2020

Journal of Ophthalmology

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Purpose. To explore the disease progression of primary open-angle glaucoma (POAG) in individuals with different degrees of VF defects by analyzing the trends in retinal nerve fiber layer (RNFL) changes at each stage. Methods. A total of 39 patients (77 eyes) were divided into three groups based on the severity of glaucomatous visual field (VF) loss: the first group included patients with mild baseline VF defects (mild group; n = 21 eyes). The second group included patients with moderate VF defects (moderate group; n = 18 eyes). The third group included patients with severe baseline VF defects (severe group; n = 38 eyes). For all patients, slit-lamp biomicroscopy of the anterior and posterior segments and detailed fundus and optic disc inspections were performed, the intraocular pressure (IOP) was measured by Goldman tonometry, best-corrected visual acuity (BCVA) was measured, the RNFL thickness was measured by OCT, and the VF was assessed by the Octopus perimeter. All the groups were followed up postoperatively for 18 months. Results. The mean RNFL thickness was recorded for all the visits. Using simple linear regression analysis, we found that the R2 values of the three groups were 0.988, 0.982, and 0.814, respectively, and the slopes of mean RNFL thickness changes for mild, moderate, and severe baseline VF defects were −0.088, −0.082, and −0.015, respectively. Moreover, we used simple linear regression analysis to explore whether and how the speed of RNFL thinning differs across groups. The R2 values of the three groups were 0.982, 0.978, and 0.805, respectively, and the slopes for mild, moderate, and severe baseline VF defects were 0.089, 0.085, and 0.017, respectively. Conclusion. The rate of RNFL thinning is linear; RNFL thinning is the fastest in individuals with mild baseline VF defects, followed by those with moderate baseline VF defects. In individuals with severe VF defects, changes in the RNFL thickness do not appropriately reflect the progression of the disease. The clinical trial is registered with ChiCTR2000028975.

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The willingness of patients presenting with advanced glaucoma to participate in a trial comparing primary medical vs primary surgical treatment

Cited by 19 publications

References 31 publications

Structural Change Can Be Detected in Advanced-Glaucoma Eyes

Structural Change Can Be Detected in Advanced-Glaucoma Eyes

Factors influencing the enrollment in randomized controlled trials in orthopedics

Trends in the Retinal Nerve Fiber Layer Thickness Changes with Different Degrees of Visual Field Defects

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