Double-Organ Bias in Published Randomized Controlled Trials of Glaucoma

Esen, Fehim; Köstek, Mehmet; Emekli, Ahmed Serkan; Eraslan, Muhsin

doi:10.1097/ijg.0000000000000369

Cited by 26 publications

(23 citation statements)

References 14 publications

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“…However, XFG had more cases treated with maximal medical therapy and a higher score of GSS 2, as expected. In order to select only one eye per subject and avoid the double-organ bias, 34 the present study had a small number of subjects with XFG, which could limit our results and conclusions about XFG.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of corneal shape index in the evaluation of ocular hypertension, primary open-angle glaucoma and exfoliative glaucoma

Vieira

Pereira

Castro

et al. 2020

European Journal of Ophthalmology

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Purpose: The aim of the present study is to calculate Concavity Shape Index (CSI) in patients with POAG and exfoliative glaucoma (XFG) and correlate CSI with the severity of glaucoma, comparing to control and ocular hypertension (OHT) patients. Methods: This was a cross‑sectional study with 146 eyes/146 subjects: 37 healthy eyes, 23 eyes with OHT and 86 glaucoma eyes (70 with POAG, 16 with XFG). The severity of glaucoma was scored with the Glaucoma Staging System 2 (GSS2). Corvis ST® was used to calculate CSI. Results: Central corneal thickness (CCT) was significantly thinner in POAG (526 ± 40.0 µm) and XFG (520 ± 38.2 µm) than control group (553 ± 28.8 µm). CSI had no significant differences between the groups. XFG had a higher mean of GSS 2 (2.42 ± 1.38) than POAG (1.87 ± 1.55) and OHT (1.87 ± 1.55). OHT had a significantly less deformable cornea than: control (higher A1 length, lower A1 velocity, higher A2 velocity), POAG (higher A1 length, lower A1 velocity, lower deflection amplitude at highest concavity), and XFG group (lower A1 velocity, lower deflection amplitude at highest concavity), which was independent of age and CCT. No significant correlation was found between GSS 2 and CSI. Discussion: OHT patients had stiffer corneas (less deformed by the air puff) when compared to control, POAG or XFG patients. A less deformable cornea could potentially be related to a more resistant LC/peripapillary sclera. As such, this would result in a lesser optic nerve susceptibility to IOP damage.

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Section: Discussionmentioning

confidence: 99%

Efficacy of corneal shape index in the evaluation of ocular hypertension, primary open-angle glaucoma and exfoliative glaucoma

Vieira

Pereira

Castro

et al. 2020

European Journal of Ophthalmology

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“…Eyes were included when baseline BCVA ranged from 24 to 78 ETDRS letters (L) (Snellen equivalent 20/320–20/32, LogMAR 1.22–0.14). When both eyes had DME, only one eye per patient was included [ 11 ]. The right eye was included in patients whose year of birth was an even number and the left eye was included when the year of birth was an odd number.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of markers of outcome in real-world treatment of diabetic macular edema

Campos

Carmo

et al. 2018

Eye and Vis

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ObjectiveTo evaluate short-term markers of outcome in diabetic macular edema (DME).MethodsProspective interventional case series included 122 eyes of 122 patients with recently diagnosed DME. Eyes were treated with a 3-monthly loading dose of ranibizumab or aflibercept and pro re nata thereafter. Serial enhanced deep imaging SD-OCT high resolution scans were used to measure subfoveal choroidal thickness (SFCT) and central retinal thickness (CRT). Anatomic (10% CRT decrease) and functional responses (best corrected visual acuity, BCVA gain ≥5 letters) were assessed at 3 months and 6 months using univariate and multivariate analyses. Parameters tested were gender, duration of diabetes, HbA1c, hypertension, CRT, SFCT, BCVA, ellipsoid zone (EZ) status, subfoveal neuroretinal detachment (SND), anti-VEGF used and laser naivety. A logistic regression model was applied to find independent markers outcome.ResultsBCVA increased, CRT and SFCT decreased at 3 months and 6 months. Good metabolic control (p = 0.003), intact baseline EZ (p = 0.030), EZ re-grading at 3 M (p < 0.001) and laser naivety (p = 0.001) were associated with better functional outcome. The multivariate linear regression model showed that baseline SND and CRT are predictors of anatomic response, while lower baseline BCVA and intact EZ are predictors of functional response.ConclusionThe presence of SND predicts anatomic response only, while an intact EZ is critical to achieve a good functional outcome in DME.Electronic supplementary materialThe online version of this article (10.1186/s40662-018-0119-9) contains supplementary material, which is available to authorized users.

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“…Subjects were excluded if they had regular astigmatism greater than 3.50 diopters (D) or any irregular astigmatism. To avoid the double-organ bias, one eye per individual was randomly included in the analysis using a table of random numbers for randomization [ 22 ]. In a fixed sequence, all of the subjects were examined with the three NCTs, the GAT and ultrasound pachymeter (850, Humphrey Instruments, Inc., San Leandro, CA, USA) to obtain IOP and central corneal thickness (CCT) measurements, respectively.…”

Section: Methodsmentioning

confidence: 99%

Comparison of intraocular pressure as measured by three different non-contact tonometers and goldmann applanation tonometer for non-glaucomatous subjects

2017

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BackgroundTo compare the measurement of intraocular pressure (IOP) among the three different non-contact tonometers (NCT) and the Goldmann applanation tonometer (GAT) for non-glaucomatous subjects.MethodsIn 52 eyes of 52 non-glaucomatous subjects, IOP was measured sequentially with the Canon TX-20P, the Nidek NT-530P, the Topcon CT-1P, and the GAT at the same time. We evaluated the IOP-measurement agreement among the tonometers as well as the factors affecting the measurements.ResultsA significant positive correlation was shown between the IOP values obtained with GAT and each NCT. The Canon TX-20P showed statistically the most significant agreement with the GAT (ICC 0.906, 95% CI 0.837–0.946). In an analysis of the Bland-Altman plots, the Canon TX-20P also showed the largest mean bias (1.38 mmHg) but the narrowest limits of agreement (LoA) (95% LoA; ± 3.43 mmHg). The Topcon CT-1P showed the smallest mean bias (0.48 mmHg) but the widest LoA (95% LoA; ± 4.16 mmHg). The Topcon CT-1P and Nidek NT-530P both showed a significantly positive correlation between increasing central corneal thickness (CCT) and increasing IOP.ConclusionThere was a statistically significant correlation between each of the three different NCT and the GAT measurements. IOP measured with the Canon TX-20P and Topcon CT-1P tended to be higher, and with the Nidek NT-530P lower, than with the GAT. Practitioners need to know the properties of their own NCTs and their respective measurement tendencies.

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Double-Organ Bias in Published Randomized Controlled Trials of Glaucoma

Abstract: Double-organ bias was observed around 13.1% of the published RCTs, leading to inaccurate statistical testing.

Cited by 26 publications

References 14 publications

Efficacy of corneal shape index in the evaluation of ocular hypertension, primary open-angle glaucoma and exfoliative glaucoma

Efficacy of corneal shape index in the evaluation of ocular hypertension, primary open-angle glaucoma and exfoliative glaucoma

Evaluation of markers of outcome in real-world treatment of diabetic macular edema

Comparison of intraocular pressure as measured by three different non-contact tonometers and goldmann applanation tonometer for non-glaucomatous subjects

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