Abstract
purpose. The visual acuity (VA) of patients with very low vision is classified using the semiquantitative scale “counting fingers” (CF), “hand motion” (HM), “light perception” (LP), and “no light perception.” More quantitative measures would be desirable, especially for clinical studies. The results of clinical VA measurements, Early Treatment Diabetic Retinopathy Study (ETDRS) charts, and the Freiburg Visual Acuity Test (FrACT) were compared. The FrACT is a computerized visual acuity test that can present very large Landolt C optotypes when necessary.
methods. Examined were 100 eyes of 100 patients with various eye diseases (e.g., diabetic retinopathy, ARMD), covering a range of VAs from LP to decimal 0.32. The FrACT optotypes were presented on a 17-inch LCD monitor with random orientation. After extensive training, two ETDRS and FrACT measurements were obtained. The testing distance was 50 or 100 cm.
results. ETDRS and FrACT coincided closely for VA ≥ 0.02 (n = 80). ETDRS measures were successfully obtainable down to CF (at 30 cm; test–retest averaged over all patients, coefficient of variation [CV]ETDRS= 9% ± 8%), and FrACT provided reproducible measurements down to HM (test–retest CVFrACT=12% ± 11%). For CF (n = 6), both ETDRS and FrACT resulted in a mean VA of 0.014 ± 0.003 (range, 0.01–0.02). The VA results of FrACT for HM (n = 12) were 0.005 ± 0.002 (range, 0.003–0.009); the individual values were highly reproducible. No results were obtainable for LP (n = 2).
conclusions. The three acuity procedures concur above a VA of 0.02. The results suggest that the category CF at 30 cm can be replaced by 0.014, using ETDRS or FrACT. Using FrACT, one can even reproducibly quantify VA in the HM-range, yielding a mean VA of 0.005.
Visual acuity (VA) is one of the most important variables in clinical studies, and it is the most important parameter for patients. There are many different VA-tests. The Early Treatment Diabetic Retinopathy Study (ETDRS) charts
1 are used most frequently in clinical studies. Modern VA charts follow a logarithmic scale. The accepted step size is 0.1-log-unit steps, corresponding to a factor of 1.259 between the lines. Currently, VA tests do not cover the whole range of VA scale as we cannot provide accurate quantitative measurements in the lower range between the subjective measures of “counting fingers” (CF) and “no light perception” (NLP). These values below the testing range of the ETDRS charts
1 can only be roughly estimated
2 3 by using the Snellen charts, for example. One of this estimation’s problems is the difference in contrast. CF at a given distance is usually converted to a Snellen equivalent by assuming that the fingers are approximately the size of the elements of a “200 letter. ” But the contrast of a hand against a white coat is much lower than that of a black letter on a white background. Holladay
3 estimated a VA of 0.01 (decimal notation) for CF and 0.001 for “hand motion” (HM). His estimates suggest a difference of 1-log-unit step between CF and HM. Grover et al.
2 estimated a decimal VA of 0.0025 for CF, 0.002 for HM, 0.0016 for “light perception” (LP), and 0.0013 for NLP, which would only indicate a difference of 0.1-log-unit step between CF and HM and between HM and LP, meaning that the change from CF to HM would not be relevant, since typically a change of 3 lines (corresponding to a factor of two) or more is considered clinically significant. Clinical experience, however, suggests that this difference is noticeable by patients and can improve their spatial orientation and ultimately their quality of life. Reliable quantification of low VA levels, particularly of CF and HM, could resolve this question.
The Freiburg Visual Acuity Test (FrACT) is a computerized VA test that can present very large Landolt C optotypes when necessary (for details see below in equipment). We focused on patients with low vision and tried to find out whether VAs on the semiquantitative ordinal scale of CF, HM, and LP can be quantified by the FrACT. We also compared the FrACT results in patients with low vision with the results obtained using ETDRS charts and a standard clinical eye chart.
ETDRS Charts.
The Freiburg Visual Acuity Test.
Snellen Eye Chart.
All VA measurements were performed by a single examiner. While one eye was tested, the other was occluded. All subjects wore correction for the testing distance. The correction was based on the results of automatic refractometry, followed by cross cylinder optimization.
Before the main testing procedure, the standard clinical VA was determined for each subject. The patients started to read each row from the top of the Snellen eye chart and proceeded toward the bottom. This was terminated when the hit rate was less than five of eight (an approximation to 56.25%, the steepest point of the psychometric acuity function). The observation distance was 5 m if the participant could identify the largest letters on the chart at that distance. Otherwise, it was reduced to 1 m. If this was not successful (when the largest optotype could not be recognized correctly), VA was classified using the semiquantitative ordinal scale CF, HM, and LP at a distance of 30 cm.
Each patient was trained extensively with the ETDRS “R” chart and the FrACT. Two ETDRS and two FrACT measurements were then obtained in a block design, alternating in successive patients (ABBA/BAAB), where “A” stands for ETDRS and “B” for FrACT. ETDRS chart 1 and ETDRS chart 2 were alternated. All VA tests were performed in a dimly lit room. Illumination measured at the subject’s eye was 50 lux. The FrACT optotypes were presented on the monitor at a distance of 50 cm. Landolt C optotypes were displayed in one of four orientations and at high contrast. Although the FrACT can optionally display Landolt rings in eight different gap positions, we chose four positions in this study, because in a pilot study this had proven to be less confusing for elderly patients and those with low vision. During the training phase, the examiner subjectively evaluated the patient’s behavior. When right–left confounds were observed, the patient was instructed to point to the perceived direction. Only one Landolt ring was displayed at a time, and the subjects’ verbal response was entered into the computer by the examiner. Then, the next optotype was presented. When the optotypes became so small that they were in the threshold region of the psychometric acuity function, patients typically reported “I’m not sure” or “I can’t see anything.” However, to avoid bias by the subjects’ “criterion” (as the signal detection theorists call it), we used the forced-choice procedure. Thus, the patients always had to report a direction, even if based on “best guess.” This required gentle coaxing in the training phase. Forced choice was used in every one of the 3 tests compared herein. FrACT measurement terminated after a fixed number (30) trials
7 (the presentation of one optotype counts as one trial). Finally, the result was calculated and presented on the screen, optionally in Snellen format or in decimal notation. A FrACT examination was deemed unsuccessful when acuity was so low that the hit rate for the largest optotype was below 62.5%.
The ETDRS charts were presented at a distance of 50 cm for visual acuities up to decimal 0.2. For VAs higher than 0.2 and up to 0.32, the charts were presented at a distance of 100 cm. The standard procedure for VA determination using ETDRS charts has been described in detail.
1 15 It was required that the subject read down the chart letter by letter and row by row, beginning with the first letter on the top row. When the subject had difficulties reading a letter, he or she was encouraged to make a best guess. The test was stopped only when the hit rate was at chance level, despite having urged the subject to read or guess. A logMAR score was specified based on the number of letters read correctly and according to the test distance. An ETDRS examination was recorded as unsuccessful when acuity was so low that less than three of five letters in the largest line could be recognized.
The mean age of the subjects was 68 years (range, 20–92 years). From the 100 patients, 80 eyes were examined successfully with a standard clinical eye chart, 84 with ETDRS charts, and 98 with the FrACT. Eighty patients had a VA ≥ 0.02, 6 had CF, and 12 HM.
The results of the FrACT and the ETDRS charts were highly reproducible, even in patients with low vision. It was possible to expand the VA measurement down to the HM range and to replace the estimated values for CF (FrACT and ETDRS) and HM (FrACT) by quantitative measurements. The VA category CF can now be replaced by 0.014 with ETDRS or FrACT, with the latter technique also reproducibly quantifying VA in the HM range, down to a VA of 0.005.
Reproducibility was high for ETDRS and FrACT
(Fig. 1) . This results concurs with those of Arditi and Cagenello,
16 who tested the reproducibility of ETDRS charts, and those of Loumann Knudsen,
8 who tested the reproducibility of FrACT.
The comparisons across tests showed that ETDRS and FrACT coincided closely with the standard clinical eye chart results
(Fig. 2) . The VAs were comparable. ETDRS and FrACT both have relatively fine grading scales, but standard clinical eye chart’s grading scales are coarser. As reported by Bailey et al.,
17 finer grading scales improve the ability of VA tests to detect clinical change.
As shown in
Figure 3 , the agreement between ETDRS and FrACT was high. Both tests coincided closely and without systematic bias.
Only one testing distance was necessary for the FrACT in this study, because of FrACT’s wide testing range of from 0.0025 to 0.4 at a distance of 50 cm. For the ETDRS charts, two different distances (50 and 100 cm) were necessary because only a limited number of optotypes can fit on a chart. In contrast, FrACT presents one optotype at a time. Further, because FrACT chooses optotype orientation randomly, there is no danger that the patient memorizes the sequence on repeat testing.
This study included 80 patients with VA ≥ 0.02, but only 20 patients with the VA categories CF (n = 6), HM (n = 12), and LP (n = 2). This somewhat limits our current conclusion, and we plan further studies focusing on CF and HM.
Below HM, the categories LP with projection, LP without projection, and no light perception are used. Because these are detection, rather than discrimination tasks, they do not assess vision on a comparable scale.
The present results show more than 4 ‘lines’ difference between CF and HM: 0.014/0.005 = 2.8; log(2.8) = 0.45, corresponding to 4.5 lines. This supports the clinical experience that this difference is noticeable for patients. In low-vision clinics it is possible to enable patients to read words or letters if they can count fingers, but next to impossible if the patient’s VA is only HM. Therefore the difference between CF and HM is quite relevant for the patient and for the ophthalmologist. We expect that studies in patients with low vision (e.g., macular degeneration with the new medical and surgical treatments, or retinitis pigmentosa with retina implants) will markedly profit from an ability to estimate VA quantitatively and reliably in the very low VA range—for example, by using the FrACT.
In summary, the high agreement of the three acuity procedures above VA = 0.02 cross-validates all three of them—in particular, the less widely used FrACT. Furthermore, the FrACT makes reproducible and quantitative VA estimates possible down to the HM range. Based on the present results, CF can be replaced by a decimal acuity of 0.014 (≃20/1500), and HM would correspond to 0.005 (
20/4000). Thus 4 lines (in 0.1-log-unit steps) separate HM and CF, which corroborates the clinical impression that the change in VA from HM to CF is relevant. The FrACT appeared to be a valid instrument with a wide testing range that can be used for clinical studies, even in patients with low vision.
Presented at the annual meeting of the Association for Research in Vision and Ophthalmology, Fort Lauderdale, Florida, May 2005.
Submitted for publication July 27, 2005; revised October 31, 2005; accepted January 9, 2006.
Disclosure:
K. Schulze-Bonsel, None;
N. Feltgen, None;
H. Bura u, None;
L. Hansen, None;
M. Bac h, None
The publication costs of this article were defrayed in part by page charge payment. This article must therefore be marked “
advertisement” in accordance with 18 U.S.C. §1734 solely to indicate this fact.
Corresponding author: Michael Bach, Department of Ophthalmology, University of Freiburg, Killianstrasse 5, Freiburg 79106, Germany;
michael.bach@uni-freiburg.de.
Table 1. Disease Category Frequencies of the 100 Subjects
Table 1. Disease Category Frequencies of the 100 Subjects
Corneal diseases | 11 |
Cataract | 14 |
Glaucoma | 14 |
Trauma | 4 |
Uveitis | 2 |
Diabetic retinopathy | 21 |
Retinal detachment | 11 |
Age-related macular degeneration | 10 |
Macular hole | 4 |
Retinal vascular occlusion with macular edema | 2 |
Optic nerve atrophy | 2 |
High myopia | 2 |
Amblyopia | 2 |
Nystagmus | 1 |
Table 2. Quantitative Data for HM and CF
Table 2. Quantitative Data for HM and CF
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