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Optometry & Vision Science:
doi: 10.1097/OPX.0b013e31828b38f5
Original Articles

Mydriatic Visual Acuity in Diabetic Patients: A Randomized Controlled Trial

Heus, Pauline*; van Trijffel, Emiel*; Busch, Eelco M.; Lucas, Cees

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Author Information

*MSc

PhD

Ophthalmology Department, Medical Center Alkmaar, Alkmaar, The Netherlands (PH, EMB); and Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Amsterdam, The Netherlands (PH, EvT, CL).

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.optvissci.com).

Pauline Heus Medisch Centrum Alkmaar polikliniek oogheelkunde (011) Wilhelminalaan 12 1815 JD Alkmaar The Netherlands e-mail: p.heus@mca.nl

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Abstract

Purpose: The aim of this randomized controlled equivalence trial was to demonstrate that, in diabetic patients, dilating the pupils before as compared with after refraction and visual acuity assessment would not lead to different advice given to patients.

Methods: Three hundred sixteen adult patients with diabetes mellitus were randomized. The experimental group was administered tropicamide 0.5% before refraction and visual acuity assessment and the control group after refraction and visual acuity assessment. Study outcomes were the advised time till next visit, the advice on adjustment of refractive correction, further diagnostics, treatment, duration of the eye examination, and patient satisfaction.

Results: No difference was seen in advised time till next visit between the experimental group (12.39 ± 5.01 months) and the control group (12.84 ± 4.96 months) (p = 0.425). In addition, the advice concerning adjustment of refractive correction (p = 0.069), further diagnostics (p = 1.000), and therapy (p = 0.178) did not significantly differ. Waiting time was significantly shorter for the experimental group (22.25 vs. 36.18 minutes; p < 0.001). People in the experimental group were relatively more often “very satisfied” than “satisfied” in comparison with participants in the control group for “attention being paid by the optometrist” (p = 0.025) and “advice on refractive correction” (p = 0.047).

Conclusions: In diabetic patients, dilating pupils before refraction and visual acuity assessment does not lead to different advice given to patients compared with dilating pupils after refraction and visual acuity assessment, whereas waiting time significantly decreases and patient satisfaction is similar or even better. Increased efficiency is beneficial to both patients and clinicians.

For diagnosis and follow-up of diabetic retinopathy (DRP), the eye examination should include determination of best-corrected visual acuity and examination of the retina.1–5 Tropicamide is an eyedrop that is frequently used for dilating the pupils.2,3,5,6 This weak parasympathicolytic agent is a safe mydriatic with a low risk of acute glaucoma or other adverse events.5,7–9

Tropicamide not only enlarges the pupil, it also affects accommodation. Mydriasis with tropicamide might cause glare, refractive aberrations, reduction of contrast sensitivity, and changes in depth of focus.10–17 Therefore, it could potentially adversely affect visual acuity measurements. Evidence of the effect of pupil dilation on visual acuity is conflicting. Some studies showed a lower visual acuity measured with dilated pupils compared with the nondilated situation,10–16,18 whereas other studies found no difference in visual acuity before and after pupillary dilation.19–21 However, these studies differed in patient population and mydriatic agents used. Concentrations, dosage, whether the mydriatic agent is a parasympathicolytic or a sympathicomimethic, and whether a single agent or a combination of agents is used determine the extent of the mydriasis and to what extent accommodation is influenced. Because visual acuity might be influenced by pupil dilation, visual acuity and refraction are typically determined before mydriatic agents are administered. This results in an interruption during the eye examination because, after instilling mydriatic agents, it will take some time before maximum pupil dilation is achieved. In daily practice, it would be beneficial to avoid this interruption. It could lead to savings in time and to increased efficiency for both patients and clinicians.

Interrupting the eye examination could be avoided by administering dilating eyedrops earlier in the examination sequence. Visual acuity and refractive error could then be determined with pupils already dilated and ready for fundoscopic examination without interruption.

Although there is an indication that visual acuity might be decreased, it is unclear whether determination of visual acuity after dilating pupils with low-dosage tropicamide affects the conclusions of an eye examination and the advice given to the patient.

The aim of this randomized controlled equivalence trial is to demonstrate that, in diabetic patients, dilating pupils before as compared with after refraction and visual acuity assessment does not result in different advice given to patients. We evaluated advice given on time till next visit, adjustment of refractive correction, further diagnostics and treatment, and whether dilating the pupils in advance saves time and influences patient satisfaction.

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METHODS

Participants

The study was conducted at the Ophthalmology Department of the Medical Center Alkmaar, a general teaching hospital in the Netherlands, serving a largely white population. All patients aged 18 years and older with diabetes who had made an appointment for an eye examination between December 1, 2009, and March 16, 2010, were invited to take part in the study. Patients who were not able to read were excluded. Patients with contact lenses were excluded if they did not have glasses they could use during the eye examination.

Before participation, informed consent was obtained. The study design was approved by the Central Committee on Research Involving Human Subjects and is in accordance with the Declaration of Helsinki.

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Procedures

After giving informed consent, participants were randomized using a computer-generated list. Allocation was concealed.

Patients in the experimental group were administered mydriatic eyedrops by the receptionist immediately after attendance registration at the Ophthalmology Department’s reception desk. They had to wait at least 15 minutes to achieve optimal mydriasis before they were called for their examination. In the control group, the sequence of the eye examination was the usual sequence with dilation of pupils (and waiting time to achieve optimal mydriasis) during the examination, after refraction and visual acuity assessment. Pupils of all patients were dilated with one drop of 0.5% tropicamide per eye.

After patients were called in, their history was taken to identify visual problems or other ocular complaints. The type of diabetes mellitus (DM), when diagnosed, and HbA1C value were noted, as was the presence of hypertension and pregnancy. Other relevant information about ocular history (e.g., laser treatment for DM) and general health was also noted. Vertical pupil size (in 0.25 mm) was measured in photopic conditions (room illumination) with a millimeter ruler. In the experimental group, pupils were dilated, and in the control group, pupils were undilated at this time. Visual acuity was assessed for the right eye (OD) as well as for the left eye (OS) using the patient’s habitual refractive correction. An ETDRS (Early Treatment Diabetic Retinopathy Study) chart on accompanying light box was used (ETDRS “chart R,” Precision Vision, La Salle, IL) at standard room illumination. The testing distance was 4 m. Patients were asked to start reading a line that they could see fairly easy. From there, they were asked to read all letters to the bottom of the chart. Patients were encouraged to guess if they were not sure about a letter. Visual acuity (logMar) was scored at the smallest line where three of five letters were identified correctly. If patients were not able to read the top line of the chart, the testing distance was changed to 2 m or, when still unable to read the top line, to 1 m. For measurements at 2 m and 1 m, respectively, 0.3 units and 0.6 units were added to the logMar score. Subjective refraction was performed aiming for “maximum plus/minimum minus,” starting with the patient’s habitual distance refractive correction or, in case the patient did not have glasses, with autorefractometer measurement (Nidek ARK 530) in a trial frame, with addition of S+0.25 to correct for the testing distance of 4 m.22 Refractive findings were converted to spherical equivalent (SE) values. The refractive correction measured in subjective refraction was used to determine the best-corrected visual acuity for the right eye and the left eye. In addition, a pinhole (diameter, <1.0 mm) visual acuity was determined for both eyes. If indicated, extra tests (e.g., tear film assessment, cover test, and ocular motility) were performed. Intraocular pressure of both eyes was measured using a Goldmann applanation tonometer after instilling Oxybuprocain HCl 0.4% and fluorescein (strips, Haag Streit). Using the slit lamp, the cornea and anterior chamber of both eyes were examined.

Patients in the control group received mydriatic eyedrops after these procedures and were sent to the waiting room for at least 15 minutes. For patients in the experimental group, the eye examination continued without interruption.

Ocular media and posterior segment of both eyes were examined under mydriasis, and any abnormalities were noted. The clarity of the lens was graded with the use of the Lens Opacities Classification System III.23 Posterior segment was assessed by indirect ophthalmoscopy (slit lamp and 90D Volk lens; indirect ophthalmoscope and 20D lens). If there was any DRP, it was graded according to the Dutch Guideline DRP (see Appendix 1, available at http://links.lww.com/OPX/A117).5 Age-related macular degeneration was graded according to the classification of Age-Related Eye Disease Study (AREDS).24 If optical coherence tomography was indicated, it was performed and noted.

At the end of the eye examination, patients received advice concerning their refractive correction and future appointments. It was noted whether the patients were advised to change their refractive correction. The advised number of months till the next visit was noted. Based on national guidelines and local protocols, most advised visit intervals were 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months, depending on the presence of risk factors and/or ocular pathology. It was recorded whether patients had to come back for further diagnostics or treatment and if this was DRP related. All patients also received a short questionnaire regarding patient satisfaction (see Appendix 2, available at http://links.lww.com/OPX/A117).

There was time registration for every patient. A chronometer was started as soon as a patient registered at the desk. It was recorded when the patient was called in by the optometrist and when he or she left. For the patients in the control group, it was also recorded when they went to the waiting room after instilling the mydriatic drops and when they were called back in.

Eight optometrists performed the eye examinations. Their clinical experience in examining eyes of diabetic patients ranged from 2 to 9 years. They were instructed to follow the study protocol, and a consensus meeting was held in advance. An ophthalmologist was available for consultation if needed. At the time of the visit, the optometrists and ophthalmologist were masked for the findings of previous eye examinations. Patient records could be reviewed afterward if necessary.

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Statistical Analysis

To reject the null hypothesis of this equivalence trial that the two groups will differ more than 3 months in “time till next visit,” it was calculated that 155 participants per group were needed, with a power of 0.90 and a significance level of 0.05, assuming an expected difference between groups of 2.5 months and an SD of 1.5 months.

Continuous data were summarized with their mean and SD in case of normally distributed continuous data. In case of non-normality, median and interquartile range were used. Categorical data were summarized as absolute and relative frequencies. Comparisons between the two groups were made with the use of unpaired t test, Mann-Whitney U test, and Pearson χ2 test, depending on the type of variable and whether variables (after transformation, if needed) are distributed normally. Multivariate linear regression was used to correct the advised “time till next visit” for relevant differences between the study groups at baseline.

All data analysis was undertaken using SPSS (version 15.0).

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Statement of Ethics

We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during this research. The study design was approved by the Central Committee on Research Involving Human Subjects and is in accordance with the Declaration of Helsinki.

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RESULTS

From December 1, 2009, and March 16, 2010, 590 eligible patients were invited by letter. Two addresses were found incorrect, 14 patients canceled their appointment, one patient turned out to be illiterate, and 257 patients were not willing to participate, leaving 316 patients who entered the study. Demographic characteristics are presented in Table 1. Patients in the experimental group had a 1-year longer duration of DM (10.42 [3.63 to 17.42] years vs. 9.42 [4.58 to 15.42] years). In the control group, there were relatively more participants with hypertension: 107 (67.3%) versus 98 (62.4%) in the experimental group. The number of “first visits” was relatively higher in the control group (12 [7.6%]) than in the experimental group (7 [4.4%]). Relatively more people in the experimental group had laser treatment in the past: 15 (9.5%) compared with 10 (6.3%) in the control group. As these differences might be of prognostic relevance, they were included in a multivariate linear regression analysis.

Table 1
Table 1
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Ocular characteristics of the two study groups are presented in Table 2.

Table 2
Table 2
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Pupil size was larger in the experimental group for the right eye (mean difference, −2.49 mm [95% confidence interval {95% CI}, −2.71 to −2.27], t309 = −22.20) as well as for the left eye (mean difference, −2.43 mm [95% CI, −2.64 to −2.22], t308 = −22.78).

Visual acuity scores differed between the two study groups. For both eyes, best-corrected visual acuity was significantly better for the control group than for the experimental group (right eye: Mdngroup1 = 0.00, Mdngroup2 = 0.04, U = 7591.50, p < 0.001; left eye: Mdngroup1 = 0.00, Mdngroup2 = 0.04, U = 7437.00, p < 0.001). Pinhole visual acuity was also significantly better in the control group versus the experimental group for the right eye (Mdngroup1 = 0.04, Mdngroup2 = 0.08, U = 7399.50, p = 0.001) as well as for the left eye (Mdngroup1 = 0.04, Mdngroup2 = 0.10, U = 6981.50, p < 0.001).

No differences were seen for SE of the refraction, difference between refraction and habitual refractive correction, lens opacities, pseudophakia, DRP, and macular degeneration. Intraocular pressure was slightly higher in the experimental group for the right eye and for the left eye (right eye: mean difference = −0.67 mm Hg [95% CI, −1.42 to 0.09], t310 = −1.740, p = 0.083; left eye: mean difference = −0.66 mm Hg [95% CI, −1.41 to 0.10], t309 = −1.717, p = 0.087).

Table 3 shows that there was no significant difference between the two study groups for the study outcome “time till next visit.” The mean time till next visit was 12.84 ± 4.96 months for the control group and 12.39 ± 5.01 months for the experimental group (mean difference = 0.45 months [95% CI, −0.66 to 1.65], t314 = 0.800, p = 0.425).

Table 3
Table 3
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The limits of the CI around the mean difference do not enclose the clinically relevant difference of 3 months. Therefore, both examination sequences can be considered equivalent. A multivariate linear regression analysis was conducted to correct for relevant differences at baseline. The mean difference in “time till next visit” between the two study groups did not change after correction for the variables “hypertension” and “first visit.” The difference did change after correction for the variables “diabetes duration” and “past history of laser treatment” from 0.45 months to 0.35 months and 0.33 months, respectively. This decrease in mean difference was of no clinical relevance, and the corrected mean difference remained nonsignificant.

The outcomes “advice on adjustment of refractive correction,” “further diagnostics,” and “treatment” did not differ significantly between the two study groups.

For the study outcome “time,” there was a statistically significant higher median waiting time for the control group (Mdngroup1 = 36.18 minutes, Mdngroup2 = 22.25 minutes, U = 5078, p < 0.001). Examination time did not differ between the groups (Mdngroup1 = 15.49 minutes, Mdngroup2 = 15.78 minutes), but “total time” did: total time in control group was 1.13 times the total time in the experimental group (p < 0.001, t test after log transformation t284 = 6.83).

For two of the five questions about patient satisfaction, the difference between groups was significant: “attention being paid by the optometrist” (Mdngroup1 = 7.00, Mdngroup2 = 7.00, p = 0.025, Fisher exact test) and “advice glasses” (Mdngroup1 = 0.00, Mdngroup2 = 4.00, p = 0.047, Fisher exact test). Although median values were equal in both groups for “attention being paid by the optometrist,” people in the experimental group scored relatively more often “very satisfied” than “satisfied” in comparison with participants in the control group, and that difference was significant.

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DISCUSSION

In this study, it was found that instilling mydriatic eyedrops in advance of refraction and visual acuity determination has obvious benefits in time without influencing the advice given to patients. Therefore, for this purpose, early pupillary dilation can be considered equivalent to pupillary dilation after refraction and visual acuity assessment. Even after correction for differences at baseline, the advised time till next visit did not change.

The total visit time was factor 1.13 longer for the control group. This was caused by a longer waiting time and the time to enter and leave the room for a second time. The time in waiting room for patients of both study groups depended on how smoothly the consulting hours progressed. Control group participants had to wait twice, whereas participants in the experimental group only had to wait once. Patients in the control group ran a risk on delay twice, and that might explain their longer waiting time.

Length of waiting time has been previously shown to correlate inversely with patient satisfaction,25–27 but in our study, patients in both groups are equally satisfied with time aspects. We found a slightly higher patient satisfaction in the experimental group for the items “attention being paid by the optometrist” and “advice on adjustment of glasses.” The fact that advice on (adjustment of) refractive correction was more frequently given in the experimental group might account for that higher satisfaction, as communication and information provision are other important factors contributing to patient satisfaction.26,28

We found that visual acuity was significantly better undilated versus dilated. This was also found in other studies in which other mydriatic agents were used.9–15,17 Although the difference is highly statistically significant, the median scores for best-corrected visual acuity of control group and experimental group are not far from each other: 0.04 corresponds to only two letters on the ETDRS chart and is clinically not relevant.

Pinhole visual acuity was also significantly better undilated versus dilated. We expected a pinhole aperture to minimize the effects of tropicamide, and therefore, we expected to find no difference in pinhole visual acuity between the two groups. The loss of luminance produced by a pinhole aperture can reduce visual acuity,29,30 and a pinhole test is a difficult test for elderly people,31 but these factors apply to people in both study groups, and no explanation for the difference was found. With the Lens Opacities Classification System III, the exact location of lens opacities is not classified, so there could have been more central lens opacities in the experimental group that reduced visual acuity. We used a single pinhole; multiple pinholes may have given different results. We are not aware of other studies in which a comparison is made in pinhole visual acuity dilated versus undilated.

There were hardly any differences found between the right eye and left eye visual acuity scores. In this study, it could have been expected that the left eye (which was tested after the right eye) would score better or that pinhole visual acuity (which was tested after the best-corrected visual acuity) would be better because of the fact that the same ETDRS chart was used in both eyes. People could have used their memory instead of their visual acuity. However, this resembles daily practice, where usually the same chart is used for determination of visual acuity of both eyes.

The SE of the refraction did not differ between the study groups. Tropicamide not only causes mydriasis, it also affects accommodation. If accommodation is paralyzed, then latent hypermetropia could be uncovered. This was not the case in our population probably because most people had low accommodation amplitude because of their age, making latent hypermetropia very unlikely. This also may help explain why no statistically significant difference was found between the two groups for the difference measured between the SE of the refraction and the SE of the habitual refractive correction.

Intraocular pressure in the experimental group was measured after pupillary dilation and was found to be slightly higher than in the control group in which pupils were measured before dilation. The difference was not statistically significant nor clinically relevant. Similar results were found in other studies.8,9,32,33 Using tropicamide 0.5% for dilation of pupils is safe, and the risk of an acute glaucoma attack is very low.5,7–9 As far as we know, no one in our study population developed acute glaucoma after dilation.

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Limitations of the Study

In this study design, masking of the optometrist and patient is impossible. This most likely did not influence our study very much; however, it is possible that the lack of masking optometrist and patients did influence the outcomes of “time” and “patient satisfaction.” Although probably not on purpose, optometrists could have been friendlier to patients in the experimental group or worked faster and influenced patient satisfaction and time by that. Because many patients had an eye examination before, it is possible that patients compared the study examination with previous examinations. For people in the experimental group, this could have biased the answers to the questionnaire because they may not have judged the examination objectively, but compared it with past visits.

The amount of missing data in the control group for the secondary outcome “time” is double the amount of missing data in the experimental group. However, we do not think p values and conclusions would have been influenced by it very much because the amount of missing data is still low (<15%) in the control group.

As pupils were dilated before the examination started in the experimental group, we were not able to test pupillary reaction. Pupillary reaction may differ in diabetic patients as compared with nondiabetic patients, and association with development of diabetic complications has been demonstrated.34,35 When implementing the studied examination sequence in daily practice, checking pupillary reaction before dilation should be considered. In additition, optometrists may feel more comfortable with checking entering visual acuity and anterior chamber angles before instilling mydriatics as well. This could be accomplished by applying our protocol to return patients only or by instilling mydriatics very early in the examination sequence.

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CONCLUSIONS

We found that dilating pupils in advance does not lead to different advice given to diabetic patients after their eye examination. There are obvious benefits in time, and patient satisfaction is equal or even improved. The savings in time and increased efficiency are beneficial to both patients and clinicians.

The population of this study is a relatively healthy, largely white, diabetic population with limited ocular pathology, good visual acuity, and low accommodation amplitude. It would be interesting to study if dilating the pupils in advance will influence the outcomes of the eye examination in other patient groups and/or in a population with more ocular pathology. The outcome of an eye examination and the advices given are based on more than visual acuity alone. Identifying which aspects of an eye examination contribute most to decision making could also be of interest for future research.

Pauline Heus

Medisch Centrum Alkmaar

polikliniek oogheelkunde (011)

Wilhelminalaan 12

1815 JD Alkmaar

The Netherlands

e-mail: p.heus@mca.nl

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ACKNOWLEDGMENTS

We thank the staff of the Ophthalmology Department of the Medical Center Alkmaar for their assistance during this study, especially the optometrists who contributed to data collection: M. Carrière-Hofstede, K. van Leeuwen-Roozendaal, W. Pepping, F. Pronker, R. Rijnja, J. Schilder, and O. Zahavi.

We also thank I. Heus for her valuable feedback on the design and data analysis of this study.

The authors declare no conflict of interest, proprietary interests, or research funding.

The work was presented orally on March 31, 2011, at the conference of the Dutch Ophthalmological Association (Nederlands Oogheelkundig Gezelschap) in Maastricht (the Netherlands) and as a poster on May 7 and 8, 2011, at the meeting of the European Academy of Optometry and Optics in Prague (Czech Republic).

Received May 5, 2012; accepted November 13, 2012.

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APPENDIX

The appendix is available online at http://links.lww.com/OPX/A117.

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Keywords:

visual acuity; pupillary dilation; mydriatics; tropicamide; diabetes mellitus; efficiency

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