Clinical and quality of life data correlation with a single-optic accommodating intraocular lens

Purpose: To examine a single-optic accommodating intraocular lens (IOL) visual performance by correlating IOL implanted eyes’ defocus curve with the intraocular aberrometric profile and the impact on the quality of life (QOL). Methods: Prospective consecutive case series study including a total of 25 eyes of 14 patients with ages ranging between 52 and 79 years old. All cases underwent cataract surgery with implantation of the single-optic accommodating IOL Crystalens HD (Bausch & Lomb). Distance and near visual acuity outcomes, intraocular aberrations, the defocus curve and QOL (NEI VFQ-25) were evaluated 3 months after surgery. Results: A significant improvement in distance visual acuity was found postoperatively (p = 0.02). Mean postoperative LogMAR uncorrected near visual acuity was 0.44 ± 0.23 (20/30). 60% of eyes had a postoperative addition between 0 and 1.5 diopters (D). The defocus curve showed an area of maximum visual acuity for the levels of defocus corresponding to distance and intermediate vision (−1 to +0.5 D). Postoperative intermediate visual acuity correlated significantly some QOL indices (r ≥ 0.51, p ≤ 0.03; difficulty in going down steps or seeing how people react to things that patient says) as well as with J0 component of manifest cylinder. Postoperative distance-corrected near visual acuity correlated significantly with age (r = 0.65, p < 0.01). Conclusions: This accommodating IOL seems to be able to restore the distance visual function as well as to provide an improvement in intermediate and near vision with a significant impact on patient's QOL, although limited by age and astigmatism. Future studies with larger sample sizes should confirm all these trends.

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.

Single-optic positional accommodating intraocular lenses: a review

Presbyopia is an age-related physiological condition that causes a gradual loss in the ability to focus on near objects, secondary to changes in zonular fibers, ciliary muscle and crystalline lens. Different surgical approaches are being pursued to surgically compensate presbyopia, such as corneal techniques or implantation of multifocal intraocular lenses (IOLs); however, their inability to restore accommodation has led to the development of single-optic positional accommodative IOLs. The axial shift, with the contraction of the ciliary muscle, of these IOLs increases the refractive power of the eye, improving the level of uncorrected near vision. Single-optic positional accommodative IOLs present few disturbances and larger ocular aberrations that improve near vision. However, reduced amplitudes of accommodation are obtained, little IOL shifts are measured and overall visual outcomes are limited.

Positional accommodative intraocular lens power error induced by the estimation of the corneal power and the effective lens position

Purpose: To evaluate the predictability of the refractive correction achieved with a positional accommodating intraocular lenses (IOL) and to develop a potential optimization of it by minimizing the error associated with the keratometric estimation of the corneal power and by developing a predictive formula for the effective lens position (ELP). Materials and Methods: Clinical data from 25 eyes of 14 patients (age range, 52–77 years) and undergoing cataract surgery with implantation of the accommodating IOL Crystalens HD (Bausch and Lomb) were retrospectively reviewed. In all cases, the calculation of an adjusted IOL power (PIOLadj) based on Gaussian optics considering the residual refractive error was done using a variable keratometric index value (nkadj) for corneal power estimation with and without using an estimation algorithm for ELP obtained by multiple regression analysis (ELPadj). PIOLadj was compared to the real IOL power implanted (PIOLReal, calculated with the SRK-T formula) and also to the values estimated by the Haigis, HofferQ, and Holladay I formulas. Results: No statistically significant differences were found between PIOLReal and PIOLadj when ELPadj was used (P = 0.10), with a range of agreement between calculations of 1.23 D. In contrast, PIOLReal was significantly higher when compared to PIOLadj without using ELPadj and also compared to the values estimated by the other formulas. Conclusions: Predictable refractive outcomes can be obtained with the accommodating IOL Crystalens HD using a variable keratometric index for corneal power estimation and by estimating ELP with an algorithm dependent on anatomical factors and age.

Development of a near activity visual questionnaire to assess accommodating intraocular lenses

Purpose: To develop a questionnaire that subjectively assesses near visual function in patients with 'accommodating' intraocular lenses (IOLs). Methods: A literature search of existing vision-related quality-of-life instruments identified all questions relating to near visual tasks. Questions were combined if repeated in multiple instruments. Further relevant questions were added and item interpretation confirmed through multidisciplinary consultation and focus groups. A preliminary 19-item questionnaire was presented to 22 subjects at their 4-week visit post first eye phacoemulsification with 'accommodative' IOL implantation, and again 6 and 12 weeks post-operatively. Rasch Analysis, Frequency of Endorsement, and tests of normality (skew and kurtosis) were used to reduce the instrument. Cronbach's alpha and test-retest reliability (intraclass correlation coefficient, ICC) were determined for the final questionnaire. Construct validity was obtained by Pearson's product moment correlation (PPMC) of questionnaire scores to reading acuity (RA) and to Critical Print Size (CPS) reading speed. Criterion validity was obtained by receiver operating characteristic (ROC) curve analysis and dimensionality of the questionnaire was assessed by factor analysis. Results: Rasch Analysis eliminated nine items due to poor fit statistics. The final items have good separation (2.55), internal consistency (Cronbach's α = 0.97) and test-retest reliability (ICC = 0.66). PPMC of questionnaire scores with RA was 0.33, and with CPS reading speed was 0.08. Area under the ROC curve was 0.88 and Factor Analysis revealed one principal factor. Conclusion: The pilot data indicates the questionnaire to be internally consistent, reliable and a valid instrument that could be useful for assessing near visual function in patients with 'accommodating' IOLS. The questionnaire will now be expanded to include other types of presbyopic correction. © 2007 British Contact Lens Association.

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.

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.

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.

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.

Influence of spherical intraocular lens implantation and conventional laser in situ keratomileusis on peripheral ocular aberrations

Aim: To measure the influence of spherical intraocular lens implantation and conventional myopic laser in situ keratomileusis on peripheral ocular aberrations. Setting: Visual & Ophthalmic Optics Laboratory, School of Optometry & Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia. Methods: Peripheral aberrations were measured using a modified commercial Hartmann-Shack aberrometer across 42° x 32° of the central visual field in 6 subjects after spherical intraocular lens (IOL) implantation and in 6 subjects after conventional laser in situ keratomileusis (LASIK) for myopia. The results were compared with those of age matched emmetropic and myopic control groups. Results: The IOL group showed a greater rate of quadratic change of spherical equivalent refraction across the visual field, higher spherical aberration, and greater rates of change of higher-order root-mean-square aberrations and total root-mean-square aberrations across the visual field than its emmetropic control group. However, coma trends were similar for the two groups. The LASIK group had a greater rate of quadratic change of spherical equivalent refraction across the visual field, higher spherical aberration, the opposite trend in coma across the field, and greater higher-order root-mean-square aberrations and total root-mean-square aberrations than its myopic control group. Conclusion: Spherical IOL implantation and conventional myopia LASIK increase ocular peripheral aberrations. They cause considerable increase in spherical aberration across the visual field. LASIK reverses the sign of the rate of change in coma across the field relative to that of the other groups. Keywords: refractive surgery, LASIK, IOL implantation, aberrations, peripheral aberrations

Cataract surgery in eyes with low corneal astigmatism : implantation of the AcrySof IQ Toric SN6AT2 intraocular lens

Purpose The aim of this study is to assess the refractive and visual outcomes following cataract surgery and implantation of the AcrySof IQ Toric SN6AT2 intraolcular lens (IOL) (Alcon Laboratories, Inc) in patients with low corneal astigmatism. Materials and Methods A retrospective, consecutive, single surgeon series of ninety-eight eyes of 88 patients following cataract surgery and implantation of the AcrySof IQ Toric SN6AT2 IOL in eyes with low preoperative corneal astigmatism. Postoperative measurements were obtained at one month post surgery. Main outcome measures were monocular distance visual acuity and residual refractive astigmatism. Results The mean preoperative corneal astigmatic power vector (APV) was 0.38 ± 0.09 D. Following surgery and implantation of the toric IOL, mean postoperative refractive APV was 0.13 ± 0.10 D. Mean postoperative distance uncorrected visual acuity (UCVA) was 0.08 ± 0.09 logMAR. Postoperative spherical equivalent refraction (SER) resulted in a mean of - 0.23 ± 0.22 D, with 96% of eyes falling within 0.50 D of the target SER. Conclusions The AcrySof IQ Toric SN6AT2 IOL is a safe and effective option for eyes undergoing cataract surgery with low amounts of preoperative corneal astigmatism.

The intraocular lens: challenges in the prevention and therapy of infectious endophthalmitis and posterior capsular opacification

Cataract is the leading cause of visual impairment worldwide. In the UK, some 30% of the population over 65 years of age have visually impairing cataract. Importantly, 88% of those with treatable visual impairment from cataract are not in contact with any ocular healthcare service, representing a major potential healthcare need [1]. In the USA, it has been estimated that 17.2% of the population (approximately 20.5 million) over 40 years of age have cataract in either eye and by 2020, this number is expected to rise to 30.1 million. Currently, cataract is responsible for 60% of Medicare costs associated with vision [2]. Furthermore, as the populations of industrialized countries such as the UK and the USA continue to age, the costs associated with treatment of cataract can only be expected to increase. Consequently, the development of the intraocular lens to replace the cataractous lens and the advances in intraocular lens design and implantation represent a major development in cataract treatment. However, despite such advances, cataract surgery is not without complications, such as postoperative infectious endophthalmitis, a rare but potentially devastating condition, and posterior capsular opacification, a less serious but much more common problem. This review will examine the epidemiology of cataracts, the polymeric construction of intraocular lenses implanted during cataract surgery and the complications of postoperative infectious endophthalmitis and posterior capsular opacification with regard to therapeutic interventions and prophylactic strategies. Advances in biomaterial design and function will be discussed as novel approaches to prevent such postoperative complications.

Novel Porphyrin-Incorporated Hydrogels for Photoactive Intraocular Lens Biomaterials

Novel surface-modified hydrogel materials have been prepared by binding charged porphyrins TMPyP (tetrakis-(4-N-methylpyridyl)porphyrin) and TPPS (tetrakis(4-sulfonatophenyl)porphyrin) to copolymers of HEMA (2-hydroxyethyl methacrylate) with either MAA (methacrylic acid) or DEAEMA (2-(diethylamino)ethylmethacrylate). The charged hydrogels display strong electrostatic interactions with the appropriate cationic or anionic porphyrins to give materials which are intended to be used to generate cytotoxic singlet oxygen (1O2) on photoexcitation and can therefore be used to reduce postoperative infection of the intraocular hydrogel-based replacement lenses that are used in cataract surgery. The UV/vis spectra of TMPyP in MAA:HEMA copolymers showed a small shift in the Soret band and a change from single exponential (161 ���­s) triplet decay lifetime in solution to a decay that could be fitted to a biexponential fit with two approximately equal components with ���´ ) 350 and 1300 ���­s. O2 bubbling reduced the decay to a dominant (90%) component with a much reduced lifetime of 3 ���­s and a minor, longer lived (20 ���­s) component. With D2O solvent the 1O2 lifetime was measured by 1270 nm fluorescence as 35 ���­s in MAA:HEMA, compared to 67 ���­s in solution, although absorbance-matched samples showed similar yield of 1O2 in the polymers and in aqueous solution. In contrast to the minor perturbation in photophysical properties caused by binding TMPyP to MAA:HEMA, TPPS binding to DEAEMA:HEMA copolymers profoundly changed the 1O2 generating ability of the TPPS. In N2-bubbled samples, the polymer-bound TPPS behaved in a similar manner to TMPyP in its copolymer host; however, O2 bubbling had only a very small effect on the triplet lifetime and no 1O2 generation could be detected. The difference in behavior may be linked to differences in binding in the two systems. With TMPyP in MAA:HEMA, confocal fluorescence microscopy showed significant penetration of the porphyrin into the core of the polymer film samples (>150 ���­m). However, for TPPS in DEAEMA:HEMA copolymers, although the porphyrin bound much more readily to the polymer, it remained localized in the first 20 ���­m, even in heavily loaded samples. It is possible that the resulting high concentration of TPPS may have cross-linked the hydrogels to such an extent that it significantly reduced the solubility and/or diffusion rate of oxygen into the doped polymers. This effect is significant since it demonstrates that even simple electrostatic binding of charged porphyrins to hydrogels can have an unexpectedly large effect on the properties of the system as a whole. In this case it makes the apparently promising TPPS/DEAEMA:HEMA system a poor candidate for clinical application as a postoperative antibacterial treatment for intraocular lenses while the apparently equivalent cationic system TMPyP/MAA:HEMA displays all the required properties.