Journal of Refractive Surgery

Original Article Supplemental Data

Pupil Diameter in Patients With Multifocal Intraocular Lenses

Joaquín Fernández, MD, PhD; Manuel Rodríguez-Vallejo, OD, PhD; Javier Martínez, OD; Noemi Burguera, OD, PhD; David P. Piñero, OD, PhD

Abstract

PURPOSE:

To evaluate the distribution of pupil size in patients implanted with multifocal intraocular lenses (IOLs) and to assess the variations according to age.

METHODS:

A total of 168 eyes that had implantation of several multifocal IOLs and were measured at the 3-month follow-up visit were included in the analysis. The Keratograph 5M (Oculus Optikgeräte) was used to measure the photopic and mesopic pupil size, as well as the average between both (average pupil size). Eyes were stratified in four groups by age: 50 years or younger, 51 to 60 years, 61 to 70 years, and older than 70 years.

RESULTS:

Considering the total sample, 84.5% and 95.8% of eyes had a photopic pupil size of 3 and 3.5 mm or less, respectively. The mesopic pupil size was greater than 4.5 mm in 39.3% and greater than 5 mm in 16.7% of eyes. The average pupil size was 3.5 and 4 mm or less in 54.2% and 85.1% of eyes, respectively. Mesopic pupil size resulted in a steeper decrease with age than photopic pupil size: 0.028 versus 0.015 mm/year, respectively. Statistically significant differences were found among the four age groups (P < .0005). No significant mean differences were found between multifocal IOL models for photopic pupil size, mesopic pupil size, or average pupil size (P > .05).

CONCLUSIONS:

Eyes implanted with multifocal IOLs had a photopic pupil size of 3.5 mm or less and mesopic pupil size of 5 mm or less. Mesopic and photopic pupil size decreased 0.28 and 0.15 mm per decade, respectively. This information can help surgeons to understand the general functioning of multifocal IOLs whose performance varies with pupil size.

[J Refract Surg. 2020;36(11):750–756.]

Abstract

PURPOSE:

To evaluate the distribution of pupil size in patients implanted with multifocal intraocular lenses (IOLs) and to assess the variations according to age.

METHODS:

A total of 168 eyes that had implantation of several multifocal IOLs and were measured at the 3-month follow-up visit were included in the analysis. The Keratograph 5M (Oculus Optikgeräte) was used to measure the photopic and mesopic pupil size, as well as the average between both (average pupil size). Eyes were stratified in four groups by age: 50 years or younger, 51 to 60 years, 61 to 70 years, and older than 70 years.

RESULTS:

Considering the total sample, 84.5% and 95.8% of eyes had a photopic pupil size of 3 and 3.5 mm or less, respectively. The mesopic pupil size was greater than 4.5 mm in 39.3% and greater than 5 mm in 16.7% of eyes. The average pupil size was 3.5 and 4 mm or less in 54.2% and 85.1% of eyes, respectively. Mesopic pupil size resulted in a steeper decrease with age than photopic pupil size: 0.028 versus 0.015 mm/year, respectively. Statistically significant differences were found among the four age groups (P < .0005). No significant mean differences were found between multifocal IOL models for photopic pupil size, mesopic pupil size, or average pupil size (P > .05).

CONCLUSIONS:

Eyes implanted with multifocal IOLs had a photopic pupil size of 3.5 mm or less and mesopic pupil size of 5 mm or less. Mesopic and photopic pupil size decreased 0.28 and 0.15 mm per decade, respectively. This information can help surgeons to understand the general functioning of multifocal IOLs whose performance varies with pupil size.

[J Refract Surg. 2020;36(11):750–756.]

Pupil size has an important role in the performance achieved after implantation of a multifocal intraocular lens (IOL). Factors contributing to this include the design of the multifocal IOL, the light energy distribution for an aperture,1–3 and the interaction of the multifocal IOL design with the corneal optics (ie, the interaction between corneal spherical aberration and the spherical aberration induced by the multifocal IOL).4 These factors can lead to variations in visual performance, including visual acuity or contrast sensitivity for some distances5,6 and the diameter of the halo size with multifocal IOLs.7,8 Possible benefits or drawbacks of some characteristics from current multifocal IOLs are a source of controversy, mainly due to the generalization of marketing messages that could be applied only to some part of the population. A clear example of this is the compensation of the mean positive spherical aberration of the cornea (0.3 µm at 6 mm)9 through the induction of negative spherical aberration in the multifocal IOL, offering controversial results among studies.10–13 In such a case, decisions are generally based on corneal spherical aberration calculated for a 6-mm pupil, directly provided by corneal tomographers,14 instead of the spherical aberration corresponding to the mesopic pupil size.15 Another example is the drawback of halo size increasing with the pupil diameter due to the parasitic near focus when patients are looking at far distance, which has been demonstrated in optical bench studies,16 but there is a lack of clinical evidence to date.17 It could probably be explained by the constriction of pupil size, reaching a different diameter than that corresponding to mesopic conditions, due to the glare source during the measurement.

The characterization of the pupil size distribution of potential candidates for multifocal IOL implantation can help surgeons make decisions about how patients might generally be helped or impaired by different multifocal IOL technologies. The aims of this study were to evaluate the distribution of pupil size in patients implanted with multifocal IOLs and to assess the influence of age in this parameter to help surgeons in the selection of multifocal IOLs considering the most frequent pupil sizes commonly seen in clinical practice.

Patients and Methods

Patients and Procedures

This retrospective study was approved by the Ethics Committee of Research, Almería Center, Torrecardenas Hospital Complex, Spain, and adhered to the tenets of the Declaration of Helsinki. A total of 168 eyes of 168 patients who had multifocal IOLs implanted and were evaluated at the 3-month postoperative visit were included in the analysis. Eyes were implanted with one of the following models: Liberty (spherical n = 96 and toric n = 6; Medicontur Medical Engineering Ltd, Inc), Alsafit (spherical n = 42; Alsanza GmbH), and AT Lisa Tri (spherical n = 8 and toric n = 16; Carl Zeiss Meditec). The optical design of these multifocal IOLs has been previously described.15,18,19

Exclusion criteria were those applicable to any multifocal IOL implantation according to standard clinical practice, including: ocular pathology that could decrease visual acuity (eg, corneal diseases, uveitis, retinopathy, glaucoma, dry eye, or amblyopia) or irregular astigmatism higher than 0.5 µm measured with Pentacam HR (Oculus Optikgeräte GmbH) at 4 mm.20 Photopic and mesopic pupil sizes measured with the Keratograph 5M (Oculus Optikgeräte GmbH) were included in the analysis and the average from both was also calculated (average pupil size). Other variables such as anterior chamber depth, axial length, and mean corneal power were obtained from the preoperative optical biometry measured with the IOLMaster 500 system (Carl Zeiss Meditec).

Device

The Keratograph 5M is a multidiagnostic system that includes a Placido disc corneal topographer and a wide-field camera. It combines white, blue (465 nm), and infrared (880 nm) diodes, allowing its use for other applications beyond corneal topography, such as the analysis of tear film dynamics, meibomian gland, and pupil diameter. The pupil diameter is dynamically measured during a period through infrared light, which allows the system to measure mesopic pupil diameter. The system includes a “Pupillogram” automated mode that measures the pupil diameter continuously in real time during the application of 0.2 second of a glare source (568 lux measured with the LX1010B digital luxmeter at our site)21 followed by 10 seconds without glare (5 lux at the environmental room light at our site), repeating the procedure up to five times. Considering that measurements were obtained in a dark room, the photopic and mesopic pupil diameters were equivalent to the mean of the minimum and maximum pupil diameters obtained during the measurement process and were automatically provided by the system. An important consideration is that the system can fail in pupil recognition and some peak artefacts can appear along the dynamic measurement. Figure A (available in the online version of this article) shows the interface of the Keratograph 5M after finishing a measurement; four dynamic plots are shown to display (A) a correct measurement and measurements with artefacts that can lead to a wrong estimation of (B) photopic, (C) mesopic, or (D) both pupil sizes. In cases such as these, pupils were obtained manually because the automated output was influenced by the artefacts.

Screen capture of the Keratography 5M software (Oculus Optikgeräte) showing (A) a perfect measurement and measurements with artefacts with the potential of leading to wrong estimations of (B) photopic, (C) mesopic, or (D) both pupil measurements. The horizontal axis represents the time during the trial consisting of periodic consecutive periods of pause, 10 seconds at environmental mesopic light of 5 lux (marked with a vertical yellow line), followed of 0.2 seconds of glare of 568 lux (red mark). The blue line represents the pupil diameter oscillations, with minimum representing the photopic pupil diameter and maximum mesopic pupil diameter.

Figure A.

Screen capture of the Keratography 5M software (Oculus Optikgeräte) showing (A) a perfect measurement and measurements with artefacts with the potential of leading to wrong estimations of (B) photopic, (C) mesopic, or (D) both pupil measurements. The horizontal axis represents the time during the trial consisting of periodic consecutive periods of pause, 10 seconds at environmental mesopic light of 5 lux (marked with a vertical yellow line), followed of 0.2 seconds of glare of 568 lux (red mark). The blue line represents the pupil diameter oscillations, with minimum representing the photopic pupil diameter and maximum mesopic pupil diameter.

Statistical Analysis

Patients were arranged in four groups according to age: 50 years or younger, 51 to 60 years, 61 to 70 years, and older than 70 years. Normal data distributions were confirmed with the Shapiro–Wilks W test. Differences between age groups were analyzed with the one-way analysis of variance and the Tukey's test for post-hoc comparisons. Influence of the multifocal IOL type after adjustment by age was tested with a oneway analysis of covariance. A simple sequential linear regression analysis was conducted to predict pupil diameter from age, including the multifocal IOL model as a possible confounding factor. Data analysis was performed using the IBM SPSS for Windows statistical software (version 24.0; SPSS, Inc).

Results

The analysis included 168 right eyes of 61 men and 107 women, with no statistically significant differences between them for photopic (t = −0.99, P = .32), mesopic (t = −0.74, P = .46), or average (t = −0.89, P = .37) pupil size. No differences were found in the mean photopic (F = 1.57, P = .16), mesopic (F = 1.37, P = .23), or average (F = 1.45, P = .20) pupil diameter among eyes implanted with different multifocal IOLs.

Table 1 shows the demographic characteristics of the eyes included in the analysis. No statistically significant differences were found for biometric eye parameters among age groups. Figure 1 shows the distribution of pupil diameters among the different age groups and Table 2 shows the cumulative percentage of eyes below or equal to a specific value of pupil diameter. Considering the total sample, 84.5% and 95.8% of eyes had a photopic pupil size below or equal to 3 and 3.5 mm, respectively. The mesopic pupil size was greater than 4.5 mm in 39.3% and 5 mm in 16.7% of eyes. The average pupil size was below or equal to 3.5 and 4 mm in 54.2% and 85.1% of eyes, respectively.

Demographic Characteristics of the Sample After Stratificationa

Table 1:

Demographic Characteristics of the Sample After Stratification

Distribution of (A) photopic, (B) mesopic, and (C) average pupil diameters according to age ranges for all eyes included in the study.

Figure 1.

Distribution of (A) photopic, (B) mesopic, and (C) average pupil diameters according to age ranges for all eyes included in the study.

Cumulative Percentage of Eyes According to the Age Range

Table 2:

Cumulative Percentage of Eyes According to the Age Range

Pupil diameters were linearly correlated with age and steeper slope for mesopic pupil size (decrease of 0.028 mm/year) compared to photopic pupil size (decrease of 0.015 mm/year) (Figure B, available in the online version of this article). The linear regression model did not improve with the inclusion of multifocal IOL type for photopic (P = .74), mesopic (P = .28), or average (P = .39) pupil size. Table 3 shows the analysis corresponding to groups stratified by age. Statistically significant differences were found between groups for the three types of pupil diameter measurement. Mean photopic pupil size ranged from 2.46 to 2.97 mm, mean mesopic pupil size ranged from 4 to 4.74 mm, and mean average pupil size ranged from 3.23 to 3.85 mm in the oldest and youngest groups, respectively.

Linear relationship between age and (A) photopic (PP), (B) mesopic (MP), and (C) average (AP) pupil diameters.

Figure B.

Linear relationship between age and (A) photopic (PP), (B) mesopic (MP), and (C) average (AP) pupil diameters.

Pupil Diameter Analysis According to Age Rangea

Table 3:

Pupil Diameter Analysis According to Age Range

Discussion

Pupil diameter is a relevant variable to be measured in the preoperative evaluation of candidates for cataract surgery. When implanting multifocal IOLs, pupil diameter is crucial to predict the visual performance that can be achieved, especially with those multifocal IOL designs on which light energy distributions vary with pupil size,22,23 and to understand its possible influence on adverse events such as dysphotopsia.8

Only postoperative measurements of pupil diameter were included in this study because the aim was to evaluate the distribution of pupil size in patients already implanted with multifocal IOLs. The change in pupil diameter after surgery was not included in the analysis because it was already covered in previous studies by our research group,15,22 with conclusions in agreement with other authors.15,22,24–26 Studies have reported a statistically significant reduction of the pupil diameter at 3 days postoperatively.27 The pupil diameter increased up to 1 month, with some authors reporting significant24 and non-significant27 differences in comparison to the preoperative values. This postoperative pupil reduction has been reported to be maintained at 3 months after surgery, with a wide agreement of a mean decrease of approximately 10%,15,22,24,25 with the exception of Ouchi and Shiba,6 who did not find any decrease in pupil diameter in comparison to the preoperative values. Therefore, surgeons should consider that the pupil diameter will be approximately 10% larger in the preoperative measurement than in the postoperative measurement.

Our results of postoperative pupil diameter are consistent with those reported by Kanellopoulos et al,24 who used a previous version of the same device to measure the pupil in pseudophakic eyes. For a sample with a mean age of 67.9 years, they reported a median of 2.54 mm for photopic and 4.13 mm for mesopic pupil size, which are almost the same medians (2.5 and 4 mm) found in our group of patients between 61 and 70 years old. A difference with their study is that all eyes were implanted with the same monofocal IOL (Acrysof IQ; Alcon Surgical, Inc), whereas our sample included eyes implanted with several multifocal IOLs. Considering that we have not found mean differences between multifocal IOL models and the median results are similar to those reported with a monofocal IOL,24 the implanted IOL might not influence the postoperative pupil diameter. However, future prospective studies are required to confirm this hypothesis because as far as we know this is the first study that includes results of postoperative pupil diameter with several multifocal IOLs.

Reduction of pupil diameter with age has been widely reported in several studies, with a slope reduction depending on light intensity and a decrease of differences between younger and older patients for photopic pupil size.28,29 These same trends have also been obtained in our series. According to Nakamura et al,29 pupil constriction is also dependent on the viewing distance of the stimulus, with approximately 0.5 mm lower mean values at 33 cm in comparison to measurements at 3 m. Despite the differences between the design of the study by Nakamura et al29 and our study in terms of the device used and the sample of eyes evaluated, a similar trend was found in terms of the relationship between age and pupil. Specifically, these authors reported a mean photopic pupil diameter for a viewing distance of 3 m of approximately 2.5 mm, with a greater change in the slope after 60 years of age.29

Photopic and mesopic represent the pupil sizes in extreme cases of light, whereas the average between both has been previously correlated with visual performance after multifocal IOL implantation.6,22,23 It is important to note that these measurements are conducted in the clinic and may not necessarily correspond to the pupil diameter of the patient during daily tasks; therefore, understanding the environmental light conditions during these tasks and the conditions of light in which the pupil was measured in the clinic might help to make decisions centered on patient needs. Unfortunately, the illuminance recommended by the international standards for patient task is given on the specified surface and not on the eye's plane.30 This means that even though recommended light at the working plane for reading tasks ranges from 300 lux in maternity wards to 500 lux in offices, libraries, and eye examination rooms,30 this does not have to be the illumination on the eye's plane. For example, Govén and Lake31 reported 235 lux at the eye plane in school for a standard normative of 500 lux at the working plane.

The standard illumination provided at the working plane represents a limitation in the understanding of vision versus tasks,32 especially in multifocal procedures in which the performance varies with the pupil diameter. Therefore, future studies with illumination at the eye plane are required to better elucidate the pupil diameter of the patient with multifocal IOLs during daily tasks.

Our study and other clinical studies29,33 have an important limitation in the comparison of results with psychophysical studies in which the pupil is measured after the adaptation to a field of view on which the angle of the field and the luminance (cd/m2) are variables related to the pupil diameter.34 Devices used in clinical practice employ a glare light reaching the eye and the environmental illuminance (lux) is used instead for reporting light conditions.29,33 As far as we know, there is no previous evidence about how psychophysical and clinical testing might differ, so care must be taken when interpreting the results according to the method used for measuring pupil diameter.

In fact, clinical devices can report different pupil diameter results. Surgeons should know the type of pupil measurement conducted by their devices and their clinical usefulness. For example, devices such as Orbscan II or Pentacam HR can only measure photopic pupil sizes,35 with the latter providing more miotic pupils, something that is consistent with the values provided by the Keratograph 5M.25 Differences might be explained by less light intensity for the photopic measurement (568 lux for the Keratograph versus 120 lux during the scanning process of the Orbscan II [measured at our site with the same luxmeter]). These photopic pupils sizes should not be confused with the average pupil size reported in some studies evaluating the pupil size influence on visual performance.6,23 For instance, Ouchi and Shiba6 evaluated the visual performance in small diameter pupils (≤ 3 mm) in comparison to large diameter pupils (> 3 mm), with mean values of 2.61 and 4.07 mm in each group, respectively. In the distribution of our sample shown in Figure AA, 2.61 mm can be clearly identified as a normal photopic pupil, whereas 4.07 mm corresponds to an extremely large photopic pupil. Therefore, although Ouchi and Shiba6 used the term photopic for their classification, the correct term used should have been average pupil, as described in the methods section of their study, and that is consistent with Figure AC of our study.

Our results concerning mesopic pupil size distribution with more than 90% of eyes with 5 mm or less after 60 years of age provide evidence that corneal spherical aberration at 6 mm is not a good parameter for selecting IOLs that correct positive spherical aberration of the cornea because patients rarely achieve this pupil size after surgery. Specifically, considering that the system is measuring the entrance pupil, not the real pupil, the projection at the real pupil plane closer to the multifocal IOL plane will correspond to values even smaller (approximately 14%).36 These findings support the idea that positive corneal spherical aberration correction with IOLs in pseudophakic patients should be reconsidered, with manufacturers providing information on spherical aberration induced at several radial chords and not a single value at 6 mm. Considering that instead of an advantage correcting positive spherical aberration, this selection could result in a disadvantage if the IOL is decentered in comparison to an IOL that does not correct positive spherical aberration.37

Some important issues related to the pupil size should be considered by cataract surgeons during the preoperative examination of candidates for multifocal IOL implantation. First, the type of multifocal IOL might not influence the pupil diameter, although this hypothesis should be confirmed with future prospective studies. Second, the pupil size decreases with age and therefore decisions should be made considering not only the age of the patient, but also the possible evolution over years. Finally, for the correction of positive spherical aberration of the cornea, the mesopic pupil size should be considered because the calculation performed by many corneal topographers for a pupil aperture of 6 mm does not represent the real mesopic pupil of patients implanted with multifocal IOLs.

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Demographic Characteristics of the Sample After Stratificationa

Age (y)No. of EyesAge (y)M/FACD (mm)AXL (mm)Km (D)
⩽ 501545.73 ± 3.63, 46 [5]6/93.31 ± 0.40, 3.35 [0.53]23.25 ± 1.98, 23.28 [3.82]43.45 ± 2.26, 43.71 [2.33]
51 to 605155.71 ± 3.08, 55 [6]20/313.17 ± 0.35, 3.16 [0.60]23.52 ± 1.45, 23.26 [1.99]43.28 ± 1.68, 43.20 [2.17]
61 to 706565.51 ± 2.98, 66 [5]21/443.12 ± 0.49, 3.10 [0.69]23.51 ± 1.24, 23.57 [1.73]43.91 ± 1.51, 44.02 [2.49]
> 703774.95 ± 2.92, 75 [5]14/233.09 ± 0.41, 3.04 [0.61]23.65 ± 0.96, 23.68 [1.03]43.45 ± 1.63, 43.36 [1.85]
F test, P1.06, .37.29, .831.41, .24

Cumulative Percentage of Eyes According to the Age Range

Pupil Diameter (mm)⩽ 50 Years51 to 60 Years61 to 70 Years> 70 YearsTotal
Photopic
  ⩽ 1.50002.70.6
  ⩽ 2.06.77.816.918.913.1
  ⩽ 2.566.725.556.959.543.5
  ⩽ 3.093.378.490.889.284.5
  ⩽ 3.510094.196.997.395.8
Mesopic
  ⩽ 3.002.06.213.56.0
  ⩽ 3.509.820.027.016.7
  ⩽ 4.013.321.652.351.439.3
  ⩽ 4.540.051.066.273.060.7
  ⩽ 5.073.370.690.891.983.3
Average
  ⩽ 2.0001.52.71.2
  ⩽ 2.502.09.28.16.0
  ⩽ 3.009.827.737.822.0
  ⩽ 3.533.335.363.173.054.2
  ⩽ 4.066.774.593.891.985.1

Pupil Diameter Analysis According to Age Rangea

Pupil Diameter (mm)⩽ 50 Years51 to 60 Years61 to 70 Years> 70 YearsF Test, P
Photopic2.97 ± 0.37, 2.90 [0.50]2.74 ± 0.41, 2.70 [0.40]2.51 ± 0.75, 2.50 [0.75]2.46 ± 0.48, 2.40 [0.65]1.46, < .0005, 1 vs 3,4; 2 vs 3,4b
Mesopic4.74 ± 0.57, 4.70 [0.90]4.61 ± 0.73, 4.50 [0.90]4.13 ± 0.75, 4.00 [1.10]4.00 ± 0.79, 4.00 [1.25]7.82, < .0005, 1 vs 3,4; 2 vs 3,4b
Average3.85 ± 0.45, 3.80 [0.80]3.68 ± 0.53, 3.65 [0.70]3.32 ± 0.55, 3.25 [0.68]3.23 ± 0.61, 3.20 [0.88]8.73, < .0005, 1 vs 3,4; 2 vs 3,4b
Authors

From the Department of Ophthalmology (Qvision), Vithas Virgen del Mar Hospital, Almería, Spain (JF, MR-V, JM, NB, DPP); the Department of Ophthalmology, Torrecárdenas Hospital Complex, Almería, Spain (JF); and the Department of Optics, Pharmacology and Anatomy, University of Alicante, Alicante, Spain (DPP).

Supported by the Ministry of Economy, Industry and Competitiveness of Spain within the program Ramón y Cajal, RYC-2016-20471 (DPP).

The authors have no financial or proprietary interest in the materials presented herein.

AUTHOR CONTRIBUTIONS

Study concept and design (JF, MR-V, JM, NB); data collection (JF, MR-V, JM, NB); analysis and interpretation of data (JF, MR-V, DPP); writing the manuscript (MR-V, DPP); critical revision of the manuscript (JF, MR-V, JM, NB); statistical expertise (MR-V); administrative, technical, or material support (JF, JM, NB); supervision (JF, MR-V, JM, NB, DPP)

Correspondence: Manuel Rodríguez-Vallejo, OD, PhD, Department of Ophthalmology (Qvision), Vithas Virgen del Mar Hospital, 04120 Almería, Spain. Email: manuelrodriguezid@qvision.es

Received: January 14, 2020
Accepted: August 05, 2020

10.3928/1081597X-20200813-01

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