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A New Manual Retinal Thickness Measurement Protocol to Evaluate High Myopia Patients

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A New Manual Retinal Thickness Measurement Protocol to Evaluate High Myopia Patients EURETINA – Original Paper Ophthalmologica Ophthalmologica Received: November 20, 2012 DOI: 10.1159/000353533 Accepted after revision: May 19, 2013 Published online: August 28, 2013 A New Manual Retinal Thickness Measurement Protocol to Evaluate High Myopia Patients a a a, c José Alberto de-Lázaro-Yagüe Alberto López-Miguel María Rosa Sanabria a, b a Itziar Fernández-Martínez Rosa María Coco-Martín a b IOBA, Universidad de Valladolid, Valladolid , and The Biomedical Research Networking Center in Bioengineering, c Biomaterials and Nanomedicine (CIBER-BBN), and Complejo Asistencial de Palencia, Palencia , Spain Key Words Introduction Pathologic myopia · Optical coherence tomography · Retinal thickness · Axial eye length · Repeatability Myopia is a refractive error in which the parallel rays entering the eye are focused ahead of the retina. Myopia is considered pathologic when the refractive error is Abstract above 6 diopters (D) [1] . The prevalence of high myopia Purpose: To validate a manual measurement protocol for has been estimated to be 2% of the population [2] . Addi- quantifying retinal thickness (RT) using an optical coherence tionally, the prevalence of pathologic myopia varies from tomography (OCT) device in pathologic myopia patients. 2% in Caucasians in occidental countries [3] to 9% in Methods: The macular Cross Hair protocol of Stratus OCT3 Asian populations [4] . (Carl Zeiss Meditec, Inc., Dublin, Calif., USA) was applied and Pathologic myopia is usually characterized by a con- manual RT gauging was performed using the caliper tool. genital scleral weakness causing progressive globe en- Foveal and paramacular RT, located at 1 and 2 mm distances largement, which produces an anomalous increase in the from the fovea in both vertical and horizontal scans, were axial eye length [5] . The staphyloma is considered to be measured. Three consecutive RT measurements were taken its hallmark lesion, and this leads to a number of variable to assess measurement reliability. The within-subject coef- degenerative ocular fundus and vitreoretinal changes in- ficient of variation (CVw ) and intraclass correlation coeffi- cluding decreased retinal thickness (RT) [6, 7] . cients (ICC) were calculated to validate the manual method. Optical coherence tomography (OCT) is a noninvasive Results: The mean axial length of the 29 eyes assessed was procedure that can record transversal sections of the reti- 28.28 ± 2.72 mm and the mean spherical refraction was na in vivo, using a coherent light based on Michelson in- –13.61 ± 6.68 diopters. CVw ranged from 0.86 to 8.73% and terferometry. It provides high-quality cross-sectional col- ICC varied from 0.81 to 0.98. Conclusion: A manual RT mea- surement protocol could reliably be used in the daily clinic for assessing pathologic myopic patients when OCT soft- The present study has been partially presented at the 12th Euretina ware segmentation fails. © 2013 S. Karger AG, Basel Congress (POS-2094) in Milan, Italy. © 2013 S. Karger AG, Basel Rosa María Coco-Martín 0030–3755/13/0000–0000$38.00/0 Edificio IOBA, Campus Miguel Delibes Paseo de Belen 17 E-Mail [email protected] ES–47011 Valladolid (Spain) www.karger.com/oph E-Mail rosa @ ioba.med.uva.es Downloaded by: Hospital Universitario 12 de Octubre, 193.146.176.31 - 9/23/2013 2:16:48 PM Color version available online 1,000 μm 1,000 μm 1,000 μm 1,000 μm Fig. 1. Manual measurement protocol. Numbers indicate the measuring sequence. or-coded reflectance map images of retinal tissue [8] . Al- review board approved this study. All the patients included with- though spectral-domain OCT is replacing time-domain in our full diagnostic database between June 2010 and June 2011 OCT (TD-OCT), the latter is still widely used in ophthal- at the IOBA Eye Institute (University of Valladolid, Spain) were considered for inclusion in this consecutive retrospective obser- mologic clinics all over the world. But the TD-OCT image vational case series study. We only enrolled Caucasian myopic quality obtained in pathologic myopia is frequently poor- patients with a myopic refractive error above 6 D with available er than in healthy eyes, and it is common to find a curved- OCT images. The OCT examination was performed with the shape retinal image due to a posterior staphyloma; thus, it Cross Hair protocol, a vertical and a horizontal 6-mm retinal is expected that automated analysis protocols sometimes scan. Patients with any other macular pathology that could have in- do not work correctly and predictably because accurate duced a change in RT (e.g. neovascular membranes, epiretinal segmentation is not always obtained [9] . membranes, macular retinoschisis, macular hole) or those with an Precise RT measurements are important in daily clinic OCT signal strength under 4 were excluded from the study. practice to avoid misleading diagnoses and to provide Manual RT measurements were obtained in 29 patients by the proper monitoring of the disease during follow-up. Conse- ‘OCT RT’ analysis method, and the distance between OCT retinal boundaries was measured using the caliper tool. The manual pro- quently, manual gauging might be a good alternative when cedure was performed by a single experienced examiner, who first the segmentation software built into the TD-OCT device placed the caliper at the level of the inner limiting membrane, and cannot properly identify retinal boundaries [10, 11], al- then at the level of the retinal pigment epithelium internal limit. though it is a time-consuming procedure. However, man- The fovea was located first and then measured at its central thin- ual RT estimation must also be reliable; thus, we designed nest point. Afterwards, RT was measured again at 1 and 2 mm from the fovea on vertical and horizontal scans. Therefore, the a manual measurement protocol gauging not only the fovea examiner obtained 10 RT measurements (5 from each retinal but also paramacular localizations in eyes of long axial scan): a central one at the fovea and 2 nasally and 2 temporally in length, which could allow a more precise characterization the horizontal scan; for the vertical scan, another 5 measurements of the retina in TD-OCT images of poor quality. Addition- were obtained: one in the center, 2 superiorly and 2 inferiorly ( fig. 1 ). ally, we calculated the intraobserver repeatability of this To validate this new manual RT measurement protocol, its re- new RT measurement protocol in order to validate our liability was calculated analyzing the intrasession repeatability of manual procedure. Besides, findings on the reliability of RT the manual measurement. Thus, 10 eyes of 10 patients out of the measurement in pathologic myopia using a Stratus OCT3 29 included in the study were selected following a computer-gen- device (Carl Zeiss Meditec, Inc., Dublin, Calif., USA) have erated random table. The same experienced examiner obtained 3 RT measurements following the manual protocol in each of the 20 not been published yet, although it was previously assessed scans of the 10 eyes selected. To avoid subjective bias when using in other retinal anomalies using the same TD-OCT [12, 13] . the caliper tool, the observer did not consecutively obtain the 3 RT measurements in each of the 5 RT locations of each scan. Actually, he gauged all the RT locations in the 20 scans of the 10 eyes se- Materials and Methods lected once, and the following day, he performed the same mea- surement procedure again, and again on the third day, so that the All procedures were performed in accordance with the Decla- examiner could not remember the previous RT values obtained for ration of Helsinki. The study was performed after obtaining in- each RT location in all the scans. These data were used to estimate formed consent from the participants, and the local institutional the manual RT measurement error. 2 Ophthalmologica de-Lázaro-Yagüe et al. DOI: 10.1159/000353533 Downloaded by: Hospital Universitario 12 de Octubre, 193.146.176.31 - 9/23/2013 2:16:48 PM Table 1. Repeatability outcomes of the manual measurement method 1 2 3 Retinal thickness localization Overall mean RT , SDw , μm Precision , Coefficient of ICC μm μm variation, % Fovea (horizontal scan) 168.45 (116 – 215) 1.46 2.86 0.86 0.97 (0.90– 0.99) 1 mm eccentricity nasally 271.76 (224 – 315) 9.33 18.28 3.43 0.88 (0.65– 0.97) 2 mm eccentricity nasally 232.44 (157 – 273) 7.42 14.54 3.19 0.96 (0.88– 0.98) 1 mm eccentricity temporally 266.76 (224 – 324) 12.66 24.81 4.74 0.89 (0.69– 0.97) 2 mm eccentricity temporally 230.19 (190 – 290) 15.92 31.20 6.91 0.94 (0.83– 0.98) Fovea (vertical scan) 169.24 (124 – 207) 2.92 5.72 1.72 0.98 (0.94– 0.99) 1 mm eccentricity superiorly 275.86 (190 – 331) 13.10 25.67 4.74 0.86 (0.61– 0.96) 2 mm eccentricity superiorly 240.17 (190 – 273) 4.04 7.91 1.68 0.98 (0.94– 0.99) 1 mm eccentricity inferiorly 274.31 (224 – 351) 23.95 46.94 8.73 0.81 (0.46– 0.94) 2 mm eccentricity inferiorly 211.66 (165 – 257) 4.02 7.87 1.89 0.93 (0.81– 0.98) 1 2 3 Values in parentheses denote ranges. 1.96 × SDw . Values in parentheses denote 95% CI. Statistical Analysis The data were entered into a database, and statistical calcula- excellent for all the locations except for the one located at tions performed by using SPSS version 18.0 for Windows (SPSS, 1 mm eccentricity inferiorly from the fovea, which can be Cary, N.C., USA). Intraobserver repeatability was assessed using qualified as good. the following parameters: within-subject standard deviation (SD w ) [14] ; precision difference between a subject’s measurement and the actual value for 95% of the observations (defined as 1.96 × Discussion SDw ); within-subject coefficient of variation (CVw ; the ratio of the SDw of the repeated measurements to the mean) [14] ; and intra- class correlation coefficient (ICC), a measurement of correlation OCT automatic analysis usually provides clinicians or consistency for data sets of repeated measurements [15] .
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