Evaluation of modern intraocular lenses

Accommodating Intraocular Lenses (IOLs), multifocal IOLs (MIOLs) and toric IOLs are designed to provide a greater level of spectacle independency post cataract surgery. All of these IOLs are reliant on the accurate calculation of intraocular lens power determined through reliable ocular biometry. A standardised defocus area metric and reading performance index metric were devised for the evaluation of the range of focus and the reading ability of subjects implanted with presbyopic correcting IOLs. The range of clear vision after implantation of an MIOL is extended by a second focal point; however, this results in the prevalence of dysphotopsia. A bespoke halometer was designed and validated to assess this photopic phenomenon. There is a lack of standardisation in the methods used for determining IOL orientation and thus rotation. A repeatable, objective method was developed to allow the accurate assessment of IOL rotation, which was used to determine the rotational and positional stability of a closed loop haptic IOL. A new commercially available biometry device was validated for use with subjects prior to cataract surgery. The optical low coherence reflectometry instrument proved to be a valid method for assessing ocular biometry and covered a wider range of ocular parameters in comparison with previous instruments. The advantages of MIOLs were shown to include an extended range of clear vision translating into greater reading ability. However, an increased prevalence of dysphotopsia was shown with a bespoke halometer, which was dependent on the MIOL optic design. Implantation of a single optic accommodating IOL did not improve reading ability but achieved high subjective ratings of near vision. The closed-loop haptic IOL displayed excellent rotational stability in the late period but relatively poor rotational stability in the early period post implantation. The orientation error was compounded by the high frequency of positional misalignment leading to an extensive overall misalignment of the IOL. This thesis demonstrates the functionality of new IOL lens designs and the importance of standardised testing methods, thus providing a greater understanding of the consequences of implanting these IOLs. Consequently, the findings of the thesis will influence future designs of IOLs and testing methods.

Does rebound tonometry probe misalignment modify intraocular pressure measurements in human eyes?

Purpose. To examine the influence of positional misalignments on intraocular pressure (IOP) measurement with a rebound tonometer. Methods. Using the iCare rebound tonometer, IOP readings were taken from the right eye of 36 healthy subjects at the central corneal apex (CC) and compared to IOP measures using the Goldmann applanation tonometer (GAT). Using a bespoke rig, iCare IOP readings were also taken 2 mm laterally from CC, both nasally and temporally, along with angular deviations of 5 and 10 degrees, both nasally and temporally to the visual axis. Results. Mean IOP ± SD, as measured by GAT, was 14.7±2.5 mmHg versus iCare tonometer readings of 17.4±3.6 mmHg at CC, representing an iCare IOP overestimation of 2.7±2.8 mmHg (P<0.001), which increased at higher average IOPs. IOP at CC using the iCare tonometer was not significantly different to values at lateral displacements. IOP was marginally underestimated with angular deviation of the probe but only reaching significance at 10 degrees nasally. Conclusions. As shown previously, the iCare tonometer overestimates IOP compared to GAT. However, IOP measurement in normal, healthy subjects using the iCare rebound tonometer appears insensitive to misalignments. An IOP underestimation of <1 mmHg with the probe deviated 10 degrees nasally reached statistical but not clinical significance levels. © 2013 Ian G. Beasley et al.

Clinical evaluation of a multifocal aspheric diffractive intraocular lens

Aim: To evaluate the performance of an aspheric diffractive multifocal acrylic intraocular lens (IOL), ZMB00 1-Piece Tecnis. Setting: Five sites across Europe. Methods: Fifty-two patients with cataracts (average age 68.5±10.5 years, 35 female) were bilaterally implanted with the aspheric diffractive multifocal IOL after completing a questionnaire regarding their optical visual symptoms, use of visual correction and their visual satisfaction. The questionnaire was completed again 4-6 months after surgery along with measures of uncorrected and best-corrected distance and near visual acuity, under photopic and mesopic lighting, reading ability, defocus curve testing and ocular examination for adverse events. Results: The residual refractive error was 0.01±0.47D with 56% of eyes within ±0.25D and 97% within ±1.0D. Uncorrected visual acuity was 0.02±0.10logMAR at distance and 0.15±0.30 logMAR at near, only reducing to 0.07±0.10logMAR at distance and 0.21±0.25logMAR at near in mesopic conditions.The defocus curve showed a near addition between 2.5-3.0 D allowing a reading acuity of 0.08±0.13 logMAR, with a range of clear vision <0.3 logMAR of ∼4.0 D. The average reading speed was 121.4±30.8 words per minute. Spectacle independence was 100% for distance and 88% for near, with high levels of satisfaction reported. Overall rating of vision without glasses could be explained (r=0.760) by preoperative best-corrected distance acuity, postoperative reading acuity and postoperative uncorrected distance acuity in photopic conditions (p<0.001). Only two minor adverse events occurred. Conclusions: The ZMB00 1-Piece Tecnis multifocal IOL provides a good visual outcome at distance and near with minimal adverse effects.

Subjective and objective performance of the Lenstec KH-3500 "accommodative" intraocular lens

Aim: To determine whether eyes implanted with the Lenstec KH-3500 "accommodative" intraocular lenses (IOLs) have improved subjective and objective focusing performance compared to a standard monofocal IOLs. Methods: 28 participants were implanted monocularly with a KH-3500 " accommodative" IOL and 20 controls with a Softec1 IOL. Outcome measures of refraction, visual acuity, subjective amplitude of accommodation, objective accommodative stimulus response curve, aberrometry, and Scheimpflug imaging were taken at ∼3 weeks and repeated after 6 months. Results: Best corrected acuity with the KH-3500 was 0.06 (SD 0.13) logMAR at distance and 0.58 (0.20) logMAR at near. Accommodation was 0.39 (0.53) D measured objectively and 3.1 (1.6) D subjectively. Higher order aberrations were 0.87 (0.85) μm and lower order were 0.24 (0.39) μm. Posterior subcapsular light scatter was 0.95% (1.37%) greater than IOL clarity. In comparison, all control group measures were similar except objective (0.17 (0.13) D; p = 0.032) and subjective (2.0 (0.9) D; p = 0.009) amplitude of accommodation. Six months following surgery, posterior subcapsular scatter had increased (p<0.01) in the KH-3500 implanted subjects and near word acuity had decreased (p<0.05). Conclusions: The objective accommodating effects of the KH-3500 IOL appear to be limited, although the subjective and objective accommodative range is significantly increased compared to control subjects implanted with conventional IOLs. However, this "accommodative" ability of the lens appears to have decreased by 6 months post-surgery.

Objective accommodative amplitude and dynamics with the 1CU accommodative intraocular lens

PURPOSE. To compare the objective accommodative amplitude and dynamics of eyes implanted with the one-compartment-unit (1CU; HumanOptics AG, Erlangen, Germany) accommodative intraocular lenses (IOLs) with that measured subjectively. METHODS. Twenty eyes with a 1CU accommodative IOL implanted were refracted and distance and near acuity measured with a logMAR (logarithm of the minimum angle of resolution) chart. The objective accommodative stimulus-response curve for static targets between 0.17 and 4.00 D accommodative demand was measured with the SRW-5000 (Shin-Nippon Commerce Inc., Tokyo, Japan) and PowerRefractor (PlusOptiX, Nürnberg, Germany) autorefractors. Continuous objective recording of dynamic accommodation was measured with the SRW-5000, with the subject viewing a target moving from 0 to 2.50 D at 0.3 Hz through a Badal lens system. Wavefront aberrometry measures (Zywave; Bausch & Lomb, Rochester, NY) were made through undilated pupils. Subjective amplitude of accommodation was measured with the RAF (Royal Air Force accommodation and vergence measurement) rule. RESULTS. Four months after implantation best-corrected acuity was -0.01 ± 0.16 logMAR at distance and 0.60 ± 0.09 logMAR at near. Objectively, the static amplitude of accommodation was 0.72 ± 0.38 D. The average dynamic amplitude of accommodation was 0.71 ± 0.47 D, with a lag behind the target of 0.50 ± 0.48 seconds. Aberrometry showed a decrease in power of the lens-eye combination from the center to the periphery in all subjects (on average, -0.38 ± 0.28 D/mm). Subjective amplitude of accommodation was 2.24 ± 0.42 D. Two years after 1CU implantation, refractive error and distance visual acuity remained relatively stable, but near visual acuity, and the subjective and objective amplitudes of accommodation decreased. CONCLUSIONS. The objective accommodating effects of the 1CU lens appear to be limited, although patients are able to track a moving target. Subjective and objective accommodation was reduced at the 2-year follow-up. The greater subjective amplitude of accommodation is likely to result from the eye's depth of focus of and the aspheric nature of the IOL. Copyright © Association for Research in Vision and Ophthalmology.

Evaluating techniques to improve visual performance with and assessment of premium intraocular lenses

Premium Intraocular Lenses (IOLs) such as toric IOLs, multifocal IOLs (MIOLs) and accommodating IOLs (AIOLs) can provide better refractive and visual outcomes compared to standard monofocal designs, leading to greater levels of post-operative spectacle independence. The principal theme of this thesis relates to the development of new assessment techniques that can help to improve future premium IOL design. IOLs designed to correct astigmatism form the focus of the first part of the thesis. A novel toric IOL design was devised to decrease the effect of toric rotation on patient visual acuity, but found to have neither a beneficial or detrimental impact on visual acuity retention. IOL tilt, like rotation, may curtail visual performance; however current IOL tilt measurement techniques require the use of specialist equipment not readily available in most ophthalmological clinics. Thus a new idea that applied Pythagoras’s theory to digital images of IOL optic symmetricality in order to calculate tilt was proposed, and shown to be both accurate and highly repeatable. A literature review revealed little information on the relationship between IOL tilt, decentration and rotation and so this was examined. A poor correlation between these factors was found, indicating they occur independently of each other. Next, presbyopia correcting IOLs were investigated. The light distribution of different MIOLs and an AIOL was assessed using perimetry, to establish whether this could be used to inform optimal IOL design. Anticipated differences in threshold sensitivity between IOLs were not however found, thus perimetry was concluded to be ineffective in mapping retinal projection of blur. The observed difference between subjective and objective measures of accommodation, arising from the influence of pseudoaccommodative factors, was explored next to establish how much additional objective power would be required to restore the eye’s focus with AIOLs. Blur tolerance was found to be the key contributor to the ocular depth of focus, with an approximate dioptric influence of 0.60D. Our understanding of MIOLs may be limited by the need for subjective defocus curves, which are lengthy and do not permit important additional measures to be undertaken. The use of aberrometry to provide faster objective defocus curves was examined. Although subjective and objective measures related well, the peaks of the MIOL defocus curve profile were not evident with objective prediction of acuity, indicating a need for further refinement of visual quality metrics based on ocular aberrations. The experiments detailed in the thesis evaluate methods to improve visual performance with toric IOLs. They also investigate new techniques to allow more rapid post-operative assessment of premium IOLs, which could allow greater insights to be obtained into several aspects of visual quality, in order to optimise future IOL design and ultimately enhance patient satisfaction.

Clinical techniques to assess the visual and optical performance of intraocular lenses:a review

A number of clinical techniques are available to assess the visual and optical performance of the eye. This report aims to review the advantages and limitations of techniques used in previous studies of patients implanted with intraocular lenses (IOLs), whose designs are ever increasing in optical complexity. Although useful, in-vitro measurements of IOL optical quality cannot account for the wide range of biological variation in ocular anatomy and corneal optics, which will impact on the visual outcome achieved. This further highlights the need for a standardised series of visual performance tests that can be applied to a wide range of IOL designs. The conclusions of this report intend to assistresearchers in developing a comprehensive series of investigations to evaluate IOL performance. Repeatable and reproducible in-vivo assessments of visual and optical performance are desirable to further develop IOL concepts and designs, in the hope of improving current postoperative visual satisfaction. © 2013 Nova Science Publishers, Inc.

The measurement of intraocular pressure over positive soft contact lenses by rebound tonometry

Purpose - To investigate if the accuracy of intraocular pressure (IOP) measurements using rebound tonometry over disposable hydrogel (etafilcon A) contact lenses (CL) is affected by the positive power of the CLs. Methods - The experimental group comprised 26 subjects, (8 male, 18 female). IOP measurements were undertaken on the subjects’ right eyes in random order using a Rebound Tonometer (ICare). The CLs had powers of +2.00 D and +6.00 D. Measurements were taken over each contact lens and also before and after the CLs had been worn. Results - The IOP measure obtained with both CLs was significantly lower compared to the value without CLs (t test; p < 0.001) but no significant difference was found between the two powers of CLs. Conclusions - Rebound tonometry over positive hydrogel CLs leads to a certain degree of IOP underestimation. This result did not change for the two positive lenses used in the experiment, despite their large difference in power and therefore in lens thickness. Optometrists should bear this in mind when measuring IOP with the rebound tonometer over plus power contact lenses.

Visual and quality outcomes following bilateral implantation of a trifocal intraocular lens

Purpose: To examine visual outcomes following bilateral implantation of the FineVision trifocal intraocular lens (IOL; PhysIOL, Liège, Belgium). Methods: 26 patients undergoing routine cataract surgery were implanted bilaterally with the FineVision Trifocal IOL and followed up post-operatively for 3 months. The FineVision optic features a combination of 2 diffractive structures, resulting in distance, intermediate (+1.75 D add) and near vision (+3.50 D add) zones. Apodization of the optic surface increases far vision dominance with pupil aperture. Data collected at the 3 month visit included uncorrected and corrected distance (CDVA) and near vision; subjective refraction; defocus curve testing (photopic and mesopic); contrast sensitivity (CSV-1000); halometry glare testing and a questionnaire (NAVQ) to gauge near vision function and patient satisfaction. Results: The cohort comprised 15 males and 11 females, aged 52.5–82.4 years (mean 70.6 ± 8.2 years). Mean post-operative UDVA was 0.22 ± 0.14 logMAR, with a mean spherical equivalent refraction of +0.02 ± 0.35 D. Mean CDVA was 0.13 ± 0.10 logMAR monocularly, and 0.09 ± 0.07 logMAR binocularly. Defocus curve testing showed an extensive range of clear vision in both photopic and mesopic conditions. Patients showed high levels of satisfaction with their near vision (mean ± 0.9 ± 0.6, where 0 = completely satisfied, and 4 = completely unsatisfied) and demonstrated good spectacle independence. Conclusion: The FineVision IOL can be considered in patients seeking spectacle dependence following cataract surgery, and provide good patient satisfaction with uncorrected vision.

Changes in intraocular pressure in study and fellow eyes in the IVAN trial

PURPOSE: To describe changes in intraocular pressure (IOP) in the 'alternative treatments to Inhibit VEGF in Age-related choroidal Neovascularisation (IVAN)' trial (registered as ISRCTN92166560). DESIGN: Randomised controlled clinical trial with factorial design. PARTICIPANTS: Patients (n=610) with treatment naïve neovascular age-related macular degeneration were enrolled and randomly assigned to receive either ranibizumab or bevacizumab and to two regimens, namely monthly (continuous) or as needed (discontinuous) treatment. METHODS: At monthly visits, IOP was measured preinjection in both eyes, and postinjection in the study eye. OUTCOME MEASURES: The effects of 10 prespecified covariates on preinjection IOP, change in IOP (postinjection minus preinjection) and the difference in preinjection IOP between the two eyes were examined. RESULTS: For every month in trial, there was a statistically significant rise in both the preinjection IOP and the change in IOP postinjection during the time in the trial (estimate 0.02 mm Hg, 95% CI 0.01 to 0.03, p<0.001 and 0.03 mm Hg, 95% CI 0.01 to 0.04, p=0.002, respectively). There was also a small but significant increase during the time in trial in the difference in IOP between the two eyes (estimate 0.01 mm Hg, 95% CI 0.005 to 0.02, p<0.001). There were no differences between bevacizumab and ranibizumab for any of the three outcomes (p=0.93, p=0.22 and p=0.87, respectively). CONCLUSIONS: Anti-vascular endothelial growth factor agents induce increases in IOP of small and uncertain clinical significance.

Can aberrometry provide rapid and reliable measures of subjective depth of focus following multifocal intraocular lens implantation?

Purpose: To determine whether the ‘through-focus’ aberrations of a multifocal and accommodative intraocular lens (IOL) implanted patient can be used to provide rapid and reliable measures of their subjective range of clear vision. Methods: Eyes that had been implanted with a concentric (n = 8), segmented (n = 10) or accommodating (n = 6) intraocular lenses (mean age 62.9 ± 8.9 years; range 46-79 years) for over a year underwent simultaneous monocular subjective (electronic logMAR test chart at 4m with letters randomised between presentations) and objective (Aston open-field aberrometer) defocus curve testing for levels of defocus between +1.50 to -5.00DS in -0.50DS steps, in a randomised order. Pupil size and ocular aberration (a combination of the patient’s and the defocus inducing lens aberrations) at each level of blur was measured by the aberrometer. Visual acuity was measured subjectively at each level of defocus to determine the traditional defocus curve. Objective acuity was predicted using image quality metrics. Results: The range of clear focus differed between the three IOL types (F=15.506, P=0.001) as well as between subjective and objective defocus curves (F=6.685, p=0.049). There was no statistically significant difference between subjective and objective defocus curves in the segmented or concentric ring MIOL group (P>0.05). However a difference was found between the two measures and the accommodating IOL group (P<0.001). Mean Delta logMAR (predicted minus measured logMAR) across all target vergences was -0.06 ± 0.19 logMAR. Predicted logMAR defocus curves for the multifocal IOLs did not show a near vision addition peak, unlike the subjective measurement of visual acuity. However, there was a strong positive correlation between measured and predicted logMAR for all three IOLs (Pearson’s correlation: P<0.001). Conclusions: Current subjective procedures are lengthy and do not enable important additional measures such as defocus curves under differently luminance or contrast levels to be assessed, which may limit our understanding of MIOL performance in real-world conditions. In general objective aberrometry measures correlated well with the subjective assessment indicating the relative robustness of this technique in evaluating post-operative success with segmented and concentric ring MIOL.