Objective analysis of toric intraocular lens rotation and centration

PURPOSE: To assess the repeatability of an objective image analysis technique to determine intraocular lens (IOL) rotation and centration. SETTING: Six ophthalmology clinics across Europe. METHODS: One-hundred seven patients implanted with Akreos AO aspheric IOLs with orientation marks were imaged. Image quality was rated by a masked observer. The axis of rotation was determined from a line bisecting the IOL orientation marks. This was normalized for rotation of the eye between visits using the axis bisecting 2 consistent conjunctival vessels or iris features. The center of ovals overlaid to circumscribe the IOL optic edge and the pupil or limbus were compared to determine IOL centration. Intrasession repeatability was assessed in 40 eyes and the variability of repeated analysis examined. RESULTS: Intrasession rotational stability of the IOL was ±0.79 degrees (SD) and centration was ±0.10 mm horizontally and ±0.10 mm vertically. Repeated analysis variability of the same image was ±0.70 degrees for rotation and ±0.20 mm horizontally and ±0.31 mm vertically for centration. Eye rotation (absolute) between visits was 2.23 ± 1.84 degrees (10%>5 degrees rotation) using one set of consistent conjunctival vessels or iris features and 2.03 ± 1.66 degrees (7%>5 degrees rotation) using the average of 2 sets (P =.13). Poorer image quality resulted in larger apparent absolute IOL rotation (r =-0.45,P<.001). CONCLUSIONS: Objective analysis of digital retroillumination images allows sensitive assessment of IOL rotation and centration stability. Eye rotation between images can lead to significant errors if not taken into account. Image quality is important to analysis accuracy.

Multifocal intraocular lens differentiation using defocus curves

Purpose: To determine the most appropriate analysis technique for the differentiation of multifocal intraocular lens (MIOL) designs using defocus curve assessment of visual capability.Methods:Four groups of fifteen subjects were implanted bilaterally with either monofocal intraocular lenses, refractive MIOLs, diffractive MIOLs, or a combination of refractive and diffractive MIOLs. Defocus curves between -5.0D and +1.5D were evaluated using an absolute and relative depth-of-focus method, the direct comparison method and a new 'Area-of-focus' metric. The results were correlated with a subjective perception of near and intermediate vision. Results:Neither depth-of-focus method of analysis were sensitive enough to differentiate between MIOL groups (p>0.05). The direct comparison method indicated that the refractive MIOL group performed better at +1.00, -1.00 and -1.50 D and worse at -3.00, -3.50, -4.00 and -5.00D compared to the diffractive MIOL group (p

Theoretical evaluation of the cataract extraction-refraction-implantation techniques for intraocular lens power calculation

PURPOSE: To evaluate theoretically three previously published formulae that use intra-operative aphakic refractive error to calculate intraocular lens (IOL) power, not necessitating pre-operative biometry. The formulae are as follows: IOL power (D) = Aphakic refraction x 2.01 [Ianchulev et al., J. Cataract Refract. Surg.31 (2005) 1530]; IOL power (D) = Aphakic refraction x 1.75 [Mackool et al., J. Cataract Refract. Surg.32 (2006) 435]; IOL power (D) = 0.07x(2) + 1.27x + 1.22, where x = aphakic refraction [Leccisotti, Graefes Arch. Clin. Exp. Ophthalmol.246 (2008) 729]. METHODS: Gaussian first order calculations were used to determine the relationship between intra-operative aphakic refractive error and the IOL power required for emmetropia in a series of schematic eyes incorporating varying corneal powers, pre-operative crystalline lens powers, axial lengths and post-operative IOL positions. The three previously published formulae, based on empirical data, were then compared in terms of IOL power errors that arose in the same schematic eye variants. RESULTS: An inverse relationship exists between theoretical ratio and axial length. Corneal power and initial lens power have little effect on calculated ratios, whilst final IOL position has a significant impact. None of the three empirically derived formulae are universally accurate but each is able to predict IOL power precisely in certain theoretical scenarios. The formulae derived by Ianchulev et al. and Leccisotti are most accurate for posterior IOL positions, whereas the Mackool et al. formula is most reliable when the IOL is located more anteriorly. CONCLUSION: Final IOL position was found to be the chief determinant of IOL power errors. Although the A-constants of IOLs are known and may be accurate, a variety of factors can still influence the final IOL position and lead to undesirable refractive errors. Optimum results using these novel formulae would be achieved in myopic eyes.

Mechanism of action of the tetraflex accommodative intraocular lens

PURPOSE:To investigate the mechanism of action of the Tetraflex (Lenstec Kellen KH-3500) accommodative intraocular lens (IOL). METHODS:Thirteen eyes of eight patients implanted with the Tetraflex accommodating IOL for at least 2 years underwent assessment of their objective amplitude-of-accommodation by autorefraction, anterior chamber depth and pupil size with optical coherence tomography, and IOL flexure with aberrometry, each viewing a target at 0.0 to 4.00 diopters of accommodative demand. RESULTS:Pupil size decreased by 0.62+/-0.41 mm on increasing accommodative demand, but the Tetraflex IOL was relatively fixed in position within the eye. The ocular aberrations of the eye changed with increased accommodative demand, but not in a consistent manner among individuals. Those aberrations that appeared to be most affected were defocus, vertical primary and secondary astigmatism, vertical coma, horizontal and vertical primary and secondary trefoil, and spherical aberration. CONCLUSIONS:Some of the reported near vision benefits of the Tetraflex accommodating IOL appear to be due to changes in the optical aberrations because of the flexure of the IOL on accommodative effort rather than forward movement within the capsular bag.

Clinical evaluation of the Softec HD aberration-free aspheric intraocular lens

Purpose: To compare distance and near visual performance with a zero-aberration aspheric intraocular lens (IOL) (Softec HD, Lenstec, Inc. FL, USA) with that of an otherwise identical, but spherical IOL (Softec 1). Setting: Department of Ophthalmology, Solihull Hospital, West Midlands, United Kingdom. Methods: This prospective study comprised 37 patients with a Softec 1 spherical IOL implanted in one eye, who underwent phacoemulsification and received the Softec HD aspheric IOL in the fellow eye. One month post-operatively, unaided distance and near vision, residual refraction, best spectacle corrected distance and near visual acuity, reading speed, pseudoaccommodation and photopic contrast sensitivity were recorded. Wavefront analysis enabled comparison of higher order aberrations between the IOLs. Results: Prior to surgery, the Softec 1 and Softec HD eyes were not significantly different. Post-operatively, unaided vision, best spectacle corrected visual acuity and residual refraction were not significantly different between the eyes, nor were there significant differences observed between the measured wavefront aberrations. Once implanted, the range of focus was significantly better in the Softec HD IOL eye than the Softec 1 IOL eye and, although reading speed was equivalent to the Softec 1 eye, the print size at which this could be achieved was significantly smaller. Conclusions: Depth of field was significantly improved with the aspheric IOL compared with the spherical IOL, without any compromise in distance visual performance between the two IOLs.

Rotational and centration stability of an aspheric intraocular lens with a simulated toric design

Purpose: To assess the stability of the Akreos AO intraocular lens (IOL) platform with a simulated toric design using objective image analysis. Setting: Six hospital eye clinics across Europe. Methods: After implantation in 1 eye of patients, IOLs with orientation marks were imaged at 1 to 2 days, 7 to 14 days, 30 to 60 days, and 120 to 180 days. The axis of rotation and IOL centration were objectively assessed using validated image analysis. Results: The study enrolled 107 patients with a mean age of 69.9 years ± 7.7 (SD). The image quality was sufficient for IOL rotation analysis in 91% of eyes. The mean rotation between the first day postoperatively and 120 to 180 days was 1.93 ± 2.33 degrees, with 96% of IOLs rotating fewer than 5 degrees and 99% rotating fewer than 10 degrees. There was no significant rotation between visits and no clear bias in the direction of rotation. In 71% of eyes, the dilation and image quality was sufficient for image analysis of centration. The mean change in centration between 1 day and 120 to 180 days was 0.21 ± 0.11 mm, with all IOLs decentering less than 0.5 mm. There was no significant decentration between visits and no clear bias in the direction of the decentration. Conclusion: Objective analysis of digital retroillumination images taken at different postoperative periods shows the aspheric IOL platform was stable in the eye and is therefore suitable for the application of a toric surface to correct corneal astigmatism.

Visual outcomes and subjective experience after bilateral implantation of a new diffractive trifocal intraocular lens

Purpose - To assess clinical outcomes and subjective experience after bilateral implantation of a diffractive trifocal intraocular lens (IOL). Setting - Midland Eye Institute, Solihull, United Kingdom. Design - Cohort study. Methods - Patients had bilateral implantation of Finevision trifocal IOLs. Uncorrected distance visual acuity, corrected distance visual acuity (CDVA), and manifest refraction were measured 2 months postoperatively. Defocus curves were assessed under photopic and mesopic conditions over a range of +1.50 to -4.00 diopters (D) in 0.50 D steps. Contrast sensitivity function was assessed under photopic conditions. Halometry was used to measure the angular size of monocular and binocular photopic scotomas arising from a glare source. Patient satisfaction with uncorrected near vision was assessed using the Near Activity Visual Questionnaire (NAVQ). Results - The mean monocular CDVA was 0.08 logMAR ± 0.08 (SD) and the mean binocular CDVA, 0.06 ± 0.08 logMAR. Defocus curve testing showed an extended range of clear vision from +1.00 to -2.50 D defocus, with a significant difference in acuity between photopic conditions and mesopic conditions at -1.50 D defocus only. Photopic contrast sensitivity was significantly better binocularly than monocularly at all spatial frequencies. Halometry showed a glare scotoma of a mean size similar to that in previous studies of multifocal and accommodating IOLs; there were no subjective complaints of dysphotopsia. The mean NAVQ Rasch score for satisfaction with near vision was 15.9 ± 10.7 logits. Conclusions - The trifocal IOL implanted binocularly produced good distance visual acuity and near and intermediate visual function. Patients were very satisfied with their uncorrected near vision.

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.

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.

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.

Biomimetic accommodating intraocular lens

The crystalline lens allows the eye to focus on near and far objects. During the aging process, it loses its ability to focus and often becomes cloudy during cataract formation. At this point, traditional medical therapy replaces the lens with an artificial replacement lens. Although replacement lenses for the crystalline lens have been implanted since 1949 for cataract surgery, none of the FDA-approved lenses mimic the anatomy of the natural lens. Hence, they are not able to focus in a manner similar to the youthful lens. Instead, they function in a manner similar to the aged lens and only provide vision at a single distance or at a very limited range of focal distances. Patients with the newest implants are often obliged to use reading glasses when using near vision, or suffer from optical aberrations, halos, or glare. Therefore, there is a need to provide youthful vision after lens surgery in terms of focusing ability, accurate optical power, and sharp focus without distortion or optical aberrations.

This thesis presents an approach to restoring youthful vision after lens replacement. An intraocular lens (IOL) that can provide accurate visual acuity along with focusing ability is proposed. This IOL relies on the natural anatomy and physiology of the eye, and therefore is actuated in a manner identical to the natural lens. In addition, the lens has the capability for adjustment during or after implantation to provide high-acuity vision throughout life.

The natural anatomy and physiology of the eye is described, along with lens replacement surgery. A lens design is proposed to address the unmet need of lens-replacement patients. Specific care in the design is made for small surgical incisions, high visual acuity, adjustable acuity over years, and the ability to focus similar to the natural lens. Methods to test the IOL using human donor tissue are developed based upon prior experiments on the ex vivo natural lens. These tools are used to demonstrate efficacy of the newly developed accommodating intraocular lens.

To further demonstrate implant feasibility, materials and processes for building the lens are evaluated for biocompatibility, endurance, repeatable manufacture, and stability. The lens biomechanics are determined after developing an artificial anatomy testing setup inspired by the natural anatomy of the human focusing mechanism. Finally, based upon a mechanical and optical knowledge of the lens, several improved lens concepts are proposed and demonstrated for efficacy.

Visual outcomes after bilateral trifocal diffractive intraocular lens implantation

Background In recent years new models of intraocular lenses are appearing on the market to reduce requirements for additional optical correction. The purpose of this study is to assess visual outcomes following bilateral cataract surgery and the implant of a FineVision® trifocal intraocular lens (IOL). Methods Prospective, nonrandomized, observational study. Vision was assessed in 44 eyes of 22 patients (mean age 68.4 ± 5.5 years) before and 3 months after surgery. Aberrations were determined using the Topcon KR-1 W wave-front analyzer. LogMAR visual acuity was measured at distance (corrected distance visual acuity, CDVA 4 m), intermediate (distance corrected intermediate visual acuity, DCIVA 60 cm) and near (distance corrected near visual acuity, DCNVA 40 cm). The Pelli-Robson letter chart and the CSV-1000 test were used to estimate contrast sensitivity (CS). Defocus curve testing was performed in photopic and mesopic conditions. Adverse photic phenomena were assessed using the Halo v1.0 program. Results Mean aberration values for a mesopic pupil diameter were: total HOA RMS: 0.41 ± 0.30 μm, coma: 0.32 ± 0.22 μm and spherical aberration: 0.21 ± 0.20 μm. Binocular logMAR measurements were: CDVA −0.05 ± 0.05, DCIVA 0.15 ± 0.10, and DCNVA 0.06 ± 0.10. Mean Pelli-Robson CS was 1.40 ± 0.14 log units. Mean CSV100 CS for the 4 frequencies examined (A: 3 cycles/degree (cpd), B: 6 cpd, C: 12 cpd, D: 18 cpd) were 1.64 ± 0.14, 1.77 ± 0.18, 1.44 ± 0.24 and 0.98 ± 0.24 log units, respectively. Significant differences were observed in defocus curves for photopic and mesopic conditions (p < 0.0001). A mean disturbance index of 0.28 ± 0.22 was obtained. Conclusions Bilateral FineVision IOL implant achieved a full range of adequate vision, satisfactory contrast sensitivity, and a lack of significant adverse photic phenomena. Trial registration Eudract Clinical Trials Registry Number: 2014-003266-2.

Fixed Mydriatic Pupil Associated with an Intraocular Pressure Rise as a Complication of the Implant of a Phakic Refractive Lens (PRL)

We describe a case report of a patient that was implanted with a posterior chamber phakic intraocular lens (Phakic Refractive Lens, PRL) for the correction of moderate myopia and who developed postoperatively a fixed mydriasis compatible with an Urrets-Zavalia Syndrome (UZS). Specifically, a sudden acute increase of IOP in the left eye was observed in the immediate postoperative period. After IOP stabilization, the refractive result was good, but a fixed and mydriatic pupil appeared. This condition led the patient to experience visual discomfort, halos, and glare associated with high levels of higher-order aberrations in spite of the good visual result. A tinted-contact lens was fitted in order to minimize those symptoms. The UZS should be considered as a possible complication after implantation of posterior chamber phakic intraocular lenses.