Objective Scatter Index: Working Toward a New Quantification of Cataract?

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1 ORIGINAL ARTICLE Objective Scatter Index: Working Toward a New Quantification of Cataract? Florence Galliot, MD, PhD; Sunni R. Patel, PhD; Béatrice Cochener, MD, PhD ABSTRACT PURPOSE: To investigate the associations between clinical cataract classifications, quality of life (QOL), and the objective loss of ocular transparency in patients presenting with clinical cataracts. METHODS: In this prospective, multicenter, crosssectional study, 1,768 eyes of 1,768 patients (mean age: 72.5 years; range: 28 to 93 years) referred for cataract assessment were enrolled. Visual acuity was measured before slit-lamp examination to determine the severity of lens opacification using the Lens Opacities Classification System III. Patients were asked to complete the Visual Function Index (VF-14) questionnaire. Ocular transparency was quantified by Objective Scatter Index (OSI) and was measured by the HD Analyzer (Visiometrics SL, Terrassa, Spain). Association and categorical data analysis were performed between each measured parameter alongside cross-tabulation analyses to determine sensitivity and efficiency of the HD Analyzer. RESULTS: High OSI levels corresponded slightly with a lower visual acuity value and corresponded better with lower VF-14 scores. OSI scores were strongly associated with cataract classification and severity. Crosstabulation analysis revealed a high sensitivity and efficiency index for the OSI with these clinically validated parameters illustrating good agreement overall for the OSI in determining cataract. CONCLUSIONS: The OSI measured by the HD Analyzer is a sensitive and efficient tool to be considered in the early detection of cataract in patients. [J Refract Surg. 2016;32(2): ] C ataracts, a consequence of lenticular opacification, lead to degradation of qualitative vision, loss of contrast sensitivity, and visual disturbances such as glare. Postoperative outcomes after intraocular lens implantation have markedly improved in the past decade. This has led to a high reduction in postoperative spectacle dependency. The major factors contributing to this advancement have been the vast improvements in intraocular lens design and phacoemulsification techniques and early detection techniques. Cataract assessment is usually based on visual acuity and lifestyle impact. More recently, ophthalmologists have been looking toward quantifying the severity of lenticular opacification to determine lifestyle and visual function impact. The HD Analyzer (Visiometrics SL, Terrassa, Spain) is the only system that objectively measures visual quality and scatter in the eye. Based on the double-pass technique, the HD Analyzer records the retinal image of a point source of light obtained after centration of an infrared signal. 1-3 The double-pass technique has been reported as being useful to examine forwardscattered light, which causes degradation of retinal images in eyes with cataract. 4 The HD Analyzer determines the Objective Scattering Index (OSI) using a point spread function, which determines how a point source of light is imaged on the retina. A high OSI score indicates degradation of the quality of the patient s vision. Moreover, the retinal image corresponds to the double-pass point spread function, enabling calculation of the maximum theoretical visual acuity and determination of the modulation transfer function. This has been used previously to understand retinal images as a function of contact lens use, age, or implantation of intraocular lenses. 5-8 From the Department of Ophthalmology, Centre Hospitalier Universitaire, Brest, France (FG, BC); and Medeuronet UK Ltd., London, United Kingdom (SRP). Submitted: August 4, 2015; Accepted: November 20, 2015 The authors have no financial or proprietary interest in the materials presented herein. Drs. Galliot and Cochener contributed equally to this work and should be considered as equal first authors. Correspondence: Béatrice Cochener, MD, PhD, Department of Ophthalmology, Centre Hospitalier Universitaire, Brest, France. beatrice.cochener@ ophtalmologie-chu29.fr doi: / x Copyright SLACK Incorporated

2 Some of our concurrent work has also investigated correlations between the OSI and functional markers. This work has furthered existing reports in the literature by determining the use of the OSI against visual acuity and the Visual Function Index-14 (VF-14) questionnaire. This study investigated associations and specifically the sensitivity and specificity to complement these results by understanding the use of the OSI better. In the current study of a large population of patients, the correlation between the clinical classification of cataract via slit-lamp examination (Lens Opacities Classification System [LOCS] III), the subjective quality of vision assessed by the VF-14, the visual acuity, and the objective loss of ocular transparency as measured by the HD Analyzer were investigated to determine any clinically and statistically significant relationships. PATIENTS AND METHODS STUDY POPULATION This was a prospective, multicenter (10-center) study. All participants were made aware of the nature of the study and informed consent was sought before enrollment. The tenets of the Declaration of Helsinki were adhered to throughout the study. The study was approved by the local institutional review board. The main inclusion criteria were a positive diagnosis of cataract (early to mature) and a competent comprehension of the French language. Exclusion criteria included a previous history of retinal and ocular pathology, ocular surface disease, and previous surgical history other than lens opacities, cataract suspicion, or both. The visual acuity was recorded for all participants and slit-lamp examination performed to note the grade and severity of cataract using the LOCS III. 9 All cataracts were classified and graded in four groups: nuclear opacity, nuclear color, cortical opacity, and posterior subcapsular opacity. The severity was graded from 1 (early cataract) to 6 (mature cataract) for the nuclear color and nuclear opacity and 1 to 5 for the cortical and posterior subcapsular opacities. VF-14 Participants were also asked to complete the VF-14 questionnaire. The VF-14 is a brief questionnaire designed to measure visual function impairment in patients with cataract. It consists of 18 questions covering 14 aspects of visual function affected by cataracts. The VF-14 shows high internal consistency and is a reliable, valid instrument providing information not conveyed by visual acuity or general health status measures A score of 100 indicates that the patient is able to do all applicable activities, whereas a score Journal of Refractive Surgery of 0 indicates that the patient is unable to do all applicable activities because of vision quality. HD ANALYZER OSI measurements were determined for each eye. The HD Analyzer measures the combined effect of higher order aberrations and scattered light using a double-pass system, thus providing information on the optical quality of the eye. A point source image is formed on the patient s retina using a 780-nm laser diode. Double-pass images of every eye were acquired in focus, corrected internally by an optometer that ranges from to diopters. Any refractive astigmatism was corrected by placing the appropriate cylindrical lens in front of the eye. Pupil alignment was monitored with an additional camera. A charge-coupled device camera records the doublepass images from the retina and beam splitter. A personal computer was used to process the retinal images and to collect the data. The double-pass instrument provides several measurements, including the OSI, the modulation transfer function, and the maximum visual acuity predicted for objects with 100%, 50%, and 9% contrast. The point spread function recorded by the asymmetric double-pass system represents the image projected onto the retina from a point light source. The point spread function was calculated as the mean of six individual acquisitions. In the absence of optical aberrations or light scattering, the point spread function is quasi point and the image perceived is unaltered (if the diffraction eventually caused by a large pupil diameter is moderate). The OSI is an objective evaluation of the scattering degree caused by the loss of transparency of one or more of the ocular structures, such as corneal opacities or cataract. This index is defined as the ratio between the integrated light in the periphery (between 12 and 20 minutes of arc) and a circular area of 1 minute of arc around the central peak of the double-pass image. The higher the OSI value, the higher the level of intraocular scattering. The resulting figure is proportional to the light diffusion rates. Normal values are less than 0.5 for a young person with a healthy eye, 13 between 1.45 and 4 for an early-stage cataract, and greater than 4 for mature cataract. The OSI parameter can be affected by uncorrected refractive errors (defocus and astigmatism). Hence, all patients had a refractive examination and all measurements were performed with best-corrected sphere and cylinder to avoid these artifacts. STATISTICAL ANALYSIS To explore the OSI as an indicator for defining cataracts and against visual acuity and quality of life, associations were explored using 2 2 tables and categorical 97

3 TABLE 1 Defined Cut-off Points Used to Determine Categories for the Categorical Data Analysis Parameter Pathological Non-pathological OSI 1.45 < 1.45 VA < VF < 84 C 1 0 NO/NC 2 < 2 P 1 0 LOCS III 3 < 3 OSI = Objective Scatter Index; VA = visual acuity; VF-14 = Visual Function Index-14; C = cortical cataract; NO/NC = nuclear opalescence/nuclear color; P = posterior subcapsular; LOCS III = Lens Opacities Classification System III TABLE 2 Baseline Characteristics of the Cohort Characteristic Mean ± SD (Range) No. of eyes 1,768 Age, y ± (28 to 93) VA ± 0.23 (0 to 1) P 0.87 ± 1.46 (0 to 6) NO/NC 5.53 ± 3.04 (0 to 12) C 1.04 ± 1.46 (0 to 5) Average OSI 4.97 ± 3.13 (0.4 to 20.5) Average VF-14 score ± (0 to 100) SD = standard deviation; VA = visual acuity; P = posterior subcapsular; NO/NC = nuclear opalescence/nuclear color; C = cortical cataract; OSI = Objective Scatter Index; VF-14 = Visual Function Index-14 TABLE 3 Populated Eyes for OSI and Determined Cut-off Points Parameter OSI 1.45 OSI > 1.45 VA > VA VF VF-14 < C C = NO/NC < NO/NC P P = LOCS < LOCS OSI = Objective Scatter Index; VA = visual acuity; VF-14 = Visual Function Index-14; C = cortical cataract; NO/NC = nuclear opalescence/nuclear color; P = posterior subcapsular; LOCS III = Lens Opacities Classification System III data analysis (sensitivity, specificity, and efficiency indices) against defined cut-off points (Table 1). Once the cutoff points for each variable were determined, population tables were constructed to give an account for how many eyes existed in each category. These were then crossclarified against each other to provide 2 2 tables that were used for categorical data analysis to determine the sensitivity (ie, proportion of correct clinical disease outcomes [or positives] identified by a measurement test [ie, OSI] or questionnaire), specificity (proportion of correct non-disease outcomes identified), and efficiency (overall proportion of correct diagnoses identified by a test or questionnaire) of the variable in determining cataract. A binomial test of proportions was used to examine significance. This is more accurate and powerful than the chisquare test. Fisher s exact test was also used, although it was unnecessary because numbers in the contingency tables considerably exceeded 50. RESULTS BASELINE CHARACTERISTICS We included 1,768 eyes of 1,768 patients in this study. As illustrated in Table 2, the mean age of the sample population was 72.5 years (range: 28 to 93 years). The average LOCS III scores for the population were posterior subcapsular 0.87 (range: 0 to 6), nuclear opalescence/nuclear color 5.53 (range: 0 to 12), and cortical cataract 1.04 (range: 0 to 5). ASSOCIATION ANALYSIS The study looked at the number of eyes within the study population against the determined cut-off values indicated in Table 1. Table 3 outlines the population of eyes when looking at the OSI against the visual acuity, VF-14, and cataract grading cut-off points. It is evident that there was a good association, with a reasonable number of eyes (n = 876) from the total population, between high OSI (better than 1.45) and lower visual acuity value (0.7 or worse). A high OSI value also corresponded well to low VF-14 scores (n = 624 eyes). There were also good associations between the number of populated eyes between each cataract grade (posterior subcapsular opacity, nuclear opalescence/nuclear color, and cortical cataract) and LOCS III with an OSI value greater than 1.45 (n = 842 eyes). Table 4 outlines the number of eyes when investigating VF-14 values against the intended cut-off 98 Copyright SLACK Incorporated

4 TABLE 4 Populated Eyes for VF-14 and Determined Cut-off Points Parameter VF VF-14 < 84 VA > VA C = C NO/NC NO/NC < P P = LOCS < LOCS VF-14 = Visual Function Index-14; VA = visual acuity; C = cortical cataract; NO/NC = nuclear opalescence/nuclear color; P = posterior subcapsular; LOCS III = Lens Opacities Classification System III points. As compared to the OSI, there was a stronger association between visual acuity and VF-14 (n = 876 vs n = 1,044 eyes). However, a weaker association was observed between posterior subcapsular (n = 57 eyes) and cortical cataracts (n = 62 eyes) with VF-14 scores. Table 5 outlines the number of eyes from the total population when using visual acuity against cataract severity. The analysis revealed better associations than for OSI and VF-14, between cortical and posterior subcapsular cataracts with visual acuity values (n= 671 and 517, respectively). Moreover, nuclear color was more associated with visual acuity than other cataract types (n = 1,299 eyes). TABLE 5 Populated Eyes for VA and Determined Cut-off Points Parameter VA > 0.7 VA 0.7 C = C NO/NC < NO/NC ,299 P = P LOCS III < LOCS III ,370 VA = visual acuity; C = cortical cataract; NO/NC = nuclear opalescence/ nuclear color; P = posterior subcapsular; LOCS III = Lens Opacities Classification System III PIVOT TABLE ANALYSES We analyzed and compared three methods of cataract screening: the HD Analyzer assessment, the VF-14 questionnaire, and visual acuity measurement. We calculated for these three tests their sensitivity, specificity, and efficacy (Table 6) to compare the HD Analyzer and VF-14 examinations with visual acuity (worse than 0.5), which is the reference test for cataract detection. OSI MEASUREMENT The OSI is a sensitive examination for cataract detection, as found by the calculated sensitivity scores of 96.5% for cortical cataracts, 93.6% for nuclear cataracts, and 100% for posterior subcapsular cataracts for an overall sensitivity of 96% for all types of cataracts. The OSI has a specificity of 76.7% for the three cataract subtypes com- TABLE 6 Categorical Data Analysis Outcomes Definition Sensitivity Specificity Efficiency OSI*VA ± ± ± OSI*C ± ± ± OSI*NO/NC ± ± ± OSI*P 100 ± ± ± OSI*Total LOCS 96 ± ± ± VF-14*VA ± ± ± VF-14*C ± ± ± VF-14*NO/NC ± ± ± VF-14*P ± ± ± VF-14*Total LOCS ± ± ± OSI = Objective Scatter Index; VA = visual acuity; C = cortical cataract; NO/NC = nuclear opacity/nuclear color; P = posterior subcapsular; total LOCS = total Lens Opacities Classification System III; VF-14 = Visual Function Index-14 Journal of Refractive Surgery 99

5 bined and is effective (89.9% for cortical cataracts, 89.4% for posterior subcapsular, and 80.4% for nuclear cataracts). VF-14 QUESTIONNAIRE The VF-14 questionnaire was slightly less sensitive than the OSI examination. We calculated a sensitivity of 65.3% for cortical cataracts, 61.3% for nuclear cataracts, and 78.1% for posterior subcapsular cataracts. The VF-14 had a specificity of 68% for all types of cataracts combined. Its efficiency was 66.2% for cortical cataracts, 61.3% for nuclear cataracts, and 74.1% for posterior subcapsular cataracts. VISUAL ACUITY We voluntarily tested two visual acuity thresholds: 0.5 or worse (reference) and 0.7 or worse. Visual acuity of 0.5 or worse was a poorly sensitive test (34% for cortical cataracts, 43% for nuclear cataracts, and 46% for posterior subcapsular cataracts), with a specificity of 93%, effective in only 54% for cortical cataracts, 46% for nuclear cataracts, and 47% for posterior subcapsular cataracts. Visual acuity of 0.7 or worse had significantly better sensitivity with 88% for cortical cataracts, 90% for nuclear cataracts, and 88% for posterior subcapsular cataracts. The specificity was the same (92%) and the efficiency was 89% for cortical and posterior subcapsular cataracts and 90% for nuclear cataracts. GENERAL ANALYSIS Of patients with cataract who had a visual acuity of 0.7 or worse, 51.8% presented a subjective change in their quality of vision (VF-14 84). We also observed that 83% of patients with cataract (LOCS III 3) with pathological light scattering (OSI > 1.45) reported impaired functioning in the questionnaire. Of patients with cataract who had a visual acuity of 0.7 or worse, 81.2% had increased ocular light scattering (OSI > 1.45). DISCUSSION We observed a mean OSI score of 3.7 for early-stage cataract, 4.8 for mild cataract, 6.2 for moderate cataract, and 10.2 for white cataract. The OSI score therefore increases with cataract severity, as previously shown in the literature. Artal et al. 7 observed that an OSI score of less than 1 corresponds to the absence of cataract, whereas a score of 2 is correlated to early-stage cataract and a score of greater than 2 corresponds to a moderate to mature cataract. Our study also shows that even early-stage cataract causes an alteration of the ocular diffusion, and therefore a deterioration in the patient s quality of vision (OSI average of 3.7 in early-stage cataract). Previous studies have demonstrated the advantage of using a double-pass system, and in particular the ability to test under different contrast conditions. Furthermore, the system demonstrates good intraobserver reproducibility. 14 Another study demonstrated good correlation between OSI and cataract grading 15 and the current study has further established this by investigating associations. Pujol et al. 16 also conducted a preliminary study on the use of OSI with subjective measures such as visual acuity and slit-lamp examination and the current study extends that work by additionally investigating VF-14. The obvious disadvantage to using the widely used LOCS system is that it is somewhat subjective, and therefore the use of imaging techniques such as the HD Analyzer or the Pentacam allow more quantitative evaluation of lens opacification. Preliminary analysis in this study showed significant associations between the OSI, VF-14, and clinical outcomes. Further in-depth analysis estimated the sensitivity, specificity, and efficiency indices of both parameters. These demonstrated the superiority of the OSI over the VF-14, both clinically and statistically (P <.001). We conducted our analysis on three cataract screening tests: visual acuity (gold standard), light scattering (OSI score), and functional impairment with the VF-14 questionnaire. These three tests all demonstrated effectiveness in the detection of cataract as already demonstrated in the literature. 17,18 Ours is so far the only study to have evaluated the sensitivity and specificity of these tests. Furthermore, the efficiency index is more relevant than a linear correlation coefficient alone, because the variables are not continuous sets of data that assume a linear relationship (ie, a change of one point in a questionnaire score does not necessarily lead consistently to a unit change in OSI or visual acuity). OSI The OSI was found to be a sensitive test for cataract detection. Indeed, we observed a sensitivity of 96%, which means that there is a 96% probability of having an OSI score of greater than 1.45 if the patient has a cataract (LOCS III score 3). Our study also showed that the OSI is a specific test. The specificity of the OSI score according to each type of cataract (cortical, nuclear, and posterior subcapsular) was calculated at 76.74%. However, even minimal lens clouding (LOCS III < 3) may induce an increase in light scattering. The positive likelihood ratio was approximately 4 for each type of cataract; this measurement represents an added value to the diagnosis and the OSI is a good tool for the detection of early cataract. VF-14 The results of this study suggest that the VF-14 is a less sensitive tool than the OSI for cataract screen- 100 Copyright SLACK Incorporated

6 ing. Indeed, the sensitivity of the VF-14 questionnaire is 65.95% for the total LOCS III score and 61.29%, 65.95%, and 78.08% for nuclear, cortical, and posterior subcapsular cataracts, respectively. The VF-14 was found to be 68% specific for cortical, nuclear, and posterior subcapsular cataracts. This questionnaire comprises a subjectivity bias. Indeed, elderly patients often minimize their functional signs and become accustomed to the degradation of their quality of vision generated by the cataract. The VF-14 questionnaire is therefore useful to quantify functional impairment in patients, but contains a subjectivity bias that does not allow the test to be as sensitive as an objective examination. The VF-14 questionnaire is useful for the diagnosis of early cataract in young adults but contributes weakly to the diagnosis of advanced cataracts in the elderly. However, it can quantify the subjective impairment experienced by patients in their daily lives. Journal of Refractive Surgery TABLE Analysis to Determine Associations Against the Defined Cut-off Points Parameter VF-14 VA > 0.7 VA 0.7 VF-14 and VA and Total LOCS < < Total Total LOCS and VA and OSI < Total 112 1,368 1,643 < 1.45 < Total < Total VF-14 = Visual Function Index-14; VA = visual acuity; LOCS = Lens Opacities Classification System III; OSI = Objective Scatter Index VISUAL ACUITY We selected two visual acuity thresholds: 0.5 or worse (current definition of cataract according to the French Medicines Agency) and 0.7 or worse. We observed that the test using a visual acuity of 0.5 or worse was less sensitive (30% to 40%) but as specific (> 90%) compared to a visual acuity cut-off of 0.7 or worse (sensitivity = 90%). The effectiveness of the screening test using a visual acuity of 0.7 or worse was two times more efficient than the reference test. Therefore, the strong sensitivity scores for OSI with visual acuity versus VF-14 that contribute to good efficiency scores (Table 7) in determining cataract in this large cohort suggest that this measure is good at detecting lenticular opacification. However, it is important to note that this study is applying associations and categorical data analysis to determine the efficiency of the OSI in identifying cataract. Whether this overall agreement is due to cause and effect is yet to be determined. Because the double-pass system measures within a small visual angle, OSI values can be highly dependent on capsule remnants or dense posterior capsule opacification in the periphery, therefore presenting a shortcoming, especially in those with large pupils. This may explain why some associations, especially with visual acuity, were weaker than expected. Although it would be expected that light scatter would be a better determinant, this is also consistent with previous reports. 14 The issue raised by Ginis et al., investigating the optical intraocular light scatter using an infrared system, also highlights a limitation of the system. 19 Nonetheless, this study does highlight particular uses for the OSI as a good indicator for cataract alongside visual acuity. In particular, the approach using pivot analyses shows good sensitivity and efficiency scores with visual acuity. This goes further than previous studies in indicating the potential clinical application of the OSI in defining and determining cataract. The sensitivity issues with the validated VF-14 may be due to the subjective nature of questionnaires and the influence of human error. The results presented in Table 7 are important. There were 65 patients with an OSI score of 1.45 or greater, and total LOCS score of 3 or greater, and yet they had good vision (visual acuity better than 0.7). This is because a patient can have a cataract and yet still maintain good vision as judged by the usual visual acuity measurement. The OSI detects the cataract, but this does not always imply poor vision and vice versa. This may account for its poor specificity with regard to visual acuity. Therefore, a suggestion for future work might be to use different OSI critical points for different variable outcomes. The authors also recognize that the sample size is a limitation of this study (ie, different eyes presenting with different types and severity of cataracts) because the type of analysis conducted would be much more robust with a larger sample of cataract severities. How- 101

7 ever, it is important to note that there are limited data available on using a double-pass system with only a small cohort of patients. This study sets a precedent to elaborate on in larger multi-site studies to investigate the clinical application and association of the OSI with the incidence of cataract. Although the study shows strong associations, whether there are correlations between these measures remains to be seen. CONCLUSION The OSI assessment was the most sensitive and most specific test for the detection of cataract, even at an early stage. A visual acuity threshold of 0.7 or worse appears to be the most sensitive and the most effective. This suggests that the associated subjective change in quality of vision is experienced early on in cataract development, despite having visual acuity excellent for driving. Even minor cataract can cause an increase in light scattering with a pathological OSI score, thus significantly affecting a patient s quality of life. In our study, we found that 81.2% of patients with cataract who had a visual acuity of 0.7 or worse had increased light scattering; more than half of these patients reported an impaired quality of life in the questionnaire. Thus, the OSI could be used as an additional surrogate measure of validating patient complaints, especially in paymodel ophthalmology practice. Overall, these initial results suggest that the OSI can provide clinicians with an overall clue and determination of lenticular changes as suggested by the high sensitivity (96% for the LOCS) and efficiency (89%) as compared to visual acuity alone. These results suggest a rationale for using the OSI and VF-14 to quantify and define visual degradation with early lenticular changes. New clinical investigations such as the OSI allow the objective evaluation of the quality of vision in patients and should, in the future, be able to assist the clinician in the detection of early cataract. To date, the distinction between true cataract and clear lens remains at the sole discretion of the surgeon. New instruments to measure the quality of vision both subjectively (VF-14 questionnaire) and objectively (HD Analyzer) should, in the future, be part of the recommendations for good surgical practice in cataract management. AUTHOR CONTRIBUTIONS Study concept and design (FG, BC); data collection (FG, BC); analysis and interpretation of data (FG, SRP, BC); writing the manuscript (FG, SRP, BC); critical revision of the manuscript (SRP); administrative, technical, or material support (SRP, BC); supervision (BC) REFERENCES 1. Westheimer G, Liang J. Evaluating diffusion of light in the eye by objective means. Invest Ophthalmol Vis Sci. 1994;35: Güell JL, Pujol J, Arjona M, Diaz-Douton F, Artal P. Optical Quality Analysis System: instrument for objective clinical evaluation of ocular optical quality. J Cataract Refract Surg. 2004;30: Saad A, Saab M, Gatinel D. 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