Preoperative Treatment of Meibomian Gland Dysfunction with a Vectored Thermal Pulsation System Prior to Extended Depth of Focus IOL Implantation.

INTRODUCTION: Patients implanted with a range-of-vision intraocular lens (IOL) (multifocal or extended depth of focus, EDOF) may be more susceptible to visual disturbances from poor tear film quality, and prophylactic treatment of meibomian gland dysfunction (MGD) has been recommended. The purpose was to evaluate whether vectored thermal pulsation (LipiFlow™) treatment prior to cataract surgery with a range-of-vision IOL safely improves postoperative outcomes. METHODS: This is a prospective, randomized, open-label, crossover, multicenter study of patients with mild-to-moderate MGD and cataract. The test group underwent LipiFlow treatment prior to cataract surgery and implantation of an EDOF IOL, while the control group did not. Both groups were evaluated 3 months postoperatively, after which the control group received LipiFlow treatment (crossover). The control group was re-evaluated 4 months postoperatively. RESULTS: A total of 121 subjects were randomized, with 117 eyes in the test group and 115 eyes in the control group. At 3 months after surgery, the test group had a significantly greater improvement from baseline in total meibomian gland score compared with the control group (P = 0.046). At 1 month after surgery, the test group had a significant decrease in corneal (P = 0.04) and conjunctival (P = 0.002) staining compared to the control group. At 3 months after surgery, the test group had significantly lower incidence of being bothered by halos compared with the control group (P = 0.019). The control group had a significantly lower incidence of being bothered by multiple or double vision compared with the test group (P = 0.016). After crossover, patients had significant improvement in vision (P = 0.03) and total meibomian gland score (P < 0.0001). No safety concerns or relevant safety findings were uncovered. CONCLUSION: Presurgical LipiFlow treatment of patients implanted with range-of-vision IOLs improved meibomian gland function and postoperative ocular surface health. This supports guidelines recommending proactive diagnosis and management of MGD in patients with cataracts to improve patient experience. TRIAL REGISTRATION: The study was registered on www. CLINICALTRIALS: gov (NCT03708367).

Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial.

PURPOSE: To compare the clinical performance of TECNIS Synergy intraocular lens (IOL), model ZFR00V, vs TECNIS IOL, model ZCB00, in cataract patients. SETTING: Multicenter clinical setting. DESIGN: Prospective, randomized, subject/evaluator-masked clinical trial. METHODS: Cataract patients aged ≥22 years were randomly assigned 1:1 to bilateral implantation with ZFR00V or ZCB00. Key end points at 6 months postsurgery included monocular and binocular visual acuities at 4 m, 66 cm, 33 cm, and/or 40 cm, binocular distance-corrected defocus testing, patient-reported outcomes, and safety. RESULTS: 272 patients were implanted with ZFR00V (135) or ZCB00 (137). At 6 months, 83/131 (63.4%) ZFR00V patients demonstrated 20/25 or better combined monocular distance-corrected vision at far, intermediate, or near, compared with 5/130 (3.8%) ZCB00 patients. ZFR00V demonstrated excellent binocular uncorrected vision at intermediate (0.022 logMAR) and distance-corrected vision at 40 cm (0.047 logMAR). Strong ZFR00V performance persisted under mesopic conditions (0.244 logMAR or ∼20/32 Snellen), where improvement over ZCB00 with distance-corrected vision at near was 3.5 lines. ZFR00V provided a broad range of functional vision (20/32 or better) through -3.5 diopters of defocus (29 cm). Most ZFR00V patients reported no spectacle wear overall (93.1%) or at all 4 viewing distances combined (87.8%), and 55.7% qualified as completely spectacle independent. Relatively low proportions of ZFR00V patients reported being very/extremely bothered by halos (13.7%), starbursts (11.5%), or night glare (8.4%). The safety profile was similar between IOL groups. CONCLUSIONS: TECNIS Synergy ZFR00V demonstrated improved intermediate and near vision, increased range of vision, and greater spectacle independence vs TECNIS monofocal ZCB00.

Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System.

Purpose: The purpose of this first in-human study was to evaluate the overall clinical performance of the VERITAS™ Vision System in patients scheduled to undergo cataract extraction and to confirm overall surgeon acceptability. Patients and methods: This prospective, open-label multinational study included adults with cataracts scheduled for planned cataract extraction and posterior chamber IOL implantation. Standard small-incision phacoemulsification cataract surgery with the VERITAS Vision System was conducted. Surgeons completed a questionnaire regarding their clinical experience with the VERITAS Vision System for each patient following surgery and 1-day postoperative. Corneal clarity and adverse events (AEs) were assessed. Surgeon acceptability was scored on a 5-point scale, with acceptability considered favorable for scores of 4 and 5. Results: A total of 115 eyes (79 patients) were treated. The El Salvador site treated 41 patients (58 eyes), and the US site treated 38 patients (57 eyes). Overall, surgeons were satisfied with the clinical performance regardless of the cataract grade. The satisfaction with anterior chamber stability, post-occlusion surge, followability, holdability, cutting efficiency, usability, and overall satisfaction with the VERITAS Vision System was clinically favorable in ≥99% of cases. Overall satisfaction with the swivel handpiece, foot pedal, and enhanced ergonomics were clinically favorable in ≥97% of cases regardless of the cataract grade. Satisfaction with corneal clarity at same-day postoperative and 1-day postoperative, and 1-day overall clinical results of surgery with the VERITAS Vision System were clinically favorable in ≥94% of cases regardless of cataract grade. Conclusion: The new dual-mode phacoemulsification system with dual-durometer tubing, gas forced infusion, new swivel handpiece, and ergonomics improvements resulted in a high rate of user satisfaction with clinical performance and ergonomics. The VERITAS Vision System is safe and effective when used as indicated.

Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial.

PURPOSE: To compare the effectiveness and safety of the TECNIS Symfony intraocular lens (IOL; ZXR00) with the TECNIS 1-piece monofocal IOL (ZCB00). SETTING: 15 sites in the United States. DESIGN: Prospective, randomized, patient-masked/evaluator-masked clinical trial. METHODS: Randomized participants received either the ZXR00 or ZCB00 IOL bilaterally. The 6-month postoperative outcomes included monocular and binocular distance, intermediate, and near visual acuity (VA), spherical equivalent refraction and refractive cylinder, spectacle wear, and visual symptoms. RESULTS: Overall, 299 patients were implanted with a study IOL (ZXR00 IOL, n = 148; ZCB00 IOL control, n = 151). At the 6-month follow-up, mean binocular uncorrected distance VA was comparable between ZXR00 and ZCB00 IOL recipients (P = .1011). The ZXR00 IOL group had significantly better mean binocular uncorrected intermediate VA and uncorrected near VA (both P < .0001) than the ZCB00 IOL group. The mean binocular distance-corrected intermediate VA and distance-corrected near VA were also better in the ZXR00 IOL group (both P < .0001). More ZXR00 IOL recipients reported wearing spectacles none of the time or a little of the time for overall vision at 6 months compared with the ZCB00 IOL group (85.0% vs 59.9%, P < .0001). In the ZXR00 IOL-implanted patients, low incidence rates of night glare (mild to moderate, 2.7%), halo (mild to moderate, 13.6%; severe, 2.7%), and starbursts (mild to moderate, 7.5%; severe, 1.4%) were reported. CONCLUSIONS: The TECNIS Symfony IOL provided comparable distance vision and improved uncorrected and distance-corrected intermediate and near vision, along with decreased spectacle wear and low incidence rates of dysphotopsia, compared with the TECNIS 1-piece monofocal IOL.

Multifocal Spectacle and Monovision Treatment of Presbyopia and Falls in the Elderly.

Presbyopia is an age-related condition that affects approximately 1.8 billion people worldwide. Strategies to correct presbyopia include both nonsurgical and surgical approaches. Although eye care providers assume that multifocal spectacles and monovision have lower risks than surgical interventions, there is evidence to suggest that the use of these nonsurgical approaches in the older population increases the risk for trips and falls. Each year, fall-related injuries and deaths are reported in a substantial portion of the population, both globally and in the United States. Previous studies have shown a link between visual acuity, contrast sensitivity, stereoacuity, and visual field impairments and falls. More recent mechanistic and epidemiological studies have shown that multifocal spectacles and monovision can increase the risk for falls as well. Although evidence on the financial burden of falls related to multifocal spectacles or monovision is limited, total direct medical costs related to falls associated with multifocal spectacles are estimated to be approximately $11 billion annually in the United States. Therefore, it is important that eye care providers consider the risk for falls associated with multifocal spectacles and monovision when making decisions on the best strategy for correcting presbyopia in older adults. [J Refract Surg. 2021;37(6 Suppl):S12-S16.].

Correlation of Intraoperative Optical Coherence Tomography of Crystalline Lens Diameter, Thickness, and Volume with Biometry and Age.

PURPOSE: To characterize crystalline lens dimensions derived from in vivo spectral-domain optical coherence tomography (SD-OCT) and identify associations among these parameters, ocular biometry, and age. METHODS: In this retrospective study, lens thickness (LT), lens diameter (LD), and lens volume (LV) were measured intraoperatively using SD-OCT in 293 eyes undergoing lens surgery. Correlations among LT, LD, LV, age, axial length (AL), and anterior chamber depth (ACD) were analyzed. Multiple regression analysis was performed to determine whether a combination of biometric data could predict LD and LV. RESULTS: Wide variations were observed in LT (3.6-5.7 mm), LD (7.5-11.9 mm), and LV (119.9-312.4 mm3) of aging eyes. Correlations among the 3 lens dimensions were statistically significant (LV-LT: r = 0.785; P < .001; LV-LD: r = 0.696; P < .001; and LT-LD: r = 0.121; P = .039). With age, the correlation coefficients of LT, LD, and LV were 0.526, 0.326, and 0.573, respectively (P < .001). Although there was significant correlation of AL with LT (r = -0.137; P = .002) and LD (r = 0.268; P < .001), it was not significant with LV (r = 0.084; P = .15). Subgroup analysis revealed that 19.8% of long eyes had LD >1 standard deviation (SD) above and that 5.2% had LD <1 SD below the mean LD. CONCLUSIONS: Dimensions of the aging lens vary considerably and are most accurately characterized by direct measurement of LT, LD, and LV, rather than making assumptions based on AL. These findings challenge historically proposed relationships between LD and AL and represent a normative dataset of contemporary geometric features of the aging lens, possibly aiding in surgical decision making and future developments in lens surgery.

Clinical evaluation of a bacterially derived sodium hyaluronate 2.3% ophthalmic viscosurgical device.

PURPOSE: To compare the safety and effectiveness of bacterially derived and animal-derived sodium hyaluronate 2.3% ophthalmic viscosurgical devices (OVD) (Healon5 PRO and Healon5, respectively) in cataract surgery. SETTING: United States multicenter study. DESIGN: Prospective, randomized, masked, controlled study. METHODS: Adult patients having bilateral cataract extraction and posterior chamber intraocular lens implantation were randomly assigned to receive Healon5 PRO OVD in 1 eye (study group) and Healon5 OVD in the fellow eye (control group). The endothelial cell count (ECC) was measured preoperatively and 3 months postoperatively. Tonometry was performed preoperatively and at the 6-hour, 1-day, 1-week, 1-month, and 3-month timepoints. The cumulative rate of postoperative intraocular pressure (IOP) spikes (≥30 mm Hg) was calculated. Changes from baseline in IOP, edema, inflammation, serious adverse events, and visual acuity were also assessed. RESULTS: The study comprised 213 and 208 treated and paired-eye patients, respectively. At 3 months, there was no statistically significant difference in the mean percentage ECC change from baseline between study group and the control group (-5.55% versus -6.66%; mean difference 1.11% ± 11.89% [SD]; 95% confidence interval (CI), -0.52 to 2.74) or the cumulative IOP spike rate (8.2% versus 6.3%; mean percentage difference -1.9%; 95% CI, -5.46% to 1.61%). At 3 months, both OVD groups had significant reductions in IOP from baseline (-1.37 mm Hg and -1.32 mm Hg, respectively; both P < .0001). The distribution of edema, inflammation, serious adverse events, and visual acuity outcomes was also similar between the groups. CONCLUSION: The 2 OVDs were clinically similar in terms of safety and effectiveness for cataract surgery.

Visual acuity and patient satisfaction at varied distances and lighting conditions after implantation of an aspheric diffractive multifocal one-piece intraocular lens.

PURPOSE: The aim of the study is to evaluate the visual acuity and patient satisfaction at varied distances under photopic and mesopic lighting conditions in patients bilaterally implanted with aspheric diffractive multifocal one-piece intraocular lenses. METHODS: In this retrospective-prospective study, 16 patients with a mean age of 66.2±9.2 years (range: 50-81 years) who had undergone bilateral phacoemulsification surgery with implantation of a Tecnis multifocal one-piece intraocular lens (ZMB00) were evaluated. Monocular and binocular uncorrected and distance-corrected visual acuities were measured at distance (20 ft), intermediate (70-80 cm), and near (35-40 cm) under photopic (85 cd/m(2)) and mesopic (3 cd/m(2)) lighting conditions and were compared using the paired t-test. All patients also completed a subjective questionnaire. RESULTS: At a mean follow-up of 9.5±3.9 months, distance, near, and intermediate visual acuity improved significantly from preoperative acuity. Under photopic and mesopic conditions, 93.8% and 62.5% of patients, respectively, had binocular uncorrected intermediate visual acuity of 20/40 or better, and 62.5% and 31.3% of patients had binocular uncorrected near visual acuity of 20/20 or better. All patients were satisfied with their overall vision without using glasses and/or contact lenses when compared with before surgery. A total of 87.5% of patients reported no glare and 68.8% of patients reported no halos around lights at night. CONCLUSION: Tecnis multifocal one-piece intraocular lenses provide good distance, intermediate, and near visual acuity under photopic as well as mesopic lighting conditions. High levels of spectacle independence with low levels of photic phenomenon were achieved, resulting in excellent patient satisfaction.

The subject-fixated coaxially sighted corneal light reflex: a clinical marker for centration of refractive treatments and devices.

PURPOSE: To describe the inconsistencies in definition, application, and usage of the ocular reference axes (optical axis, visual axis, line of sight, pupillary axis, and topographic axis) and angles (angle kappa, lambda, and alpha) and to propose a precise, reproducible, clinically defined reference marker and axis for centration of refractive treatments and devices. DESIGN: Perspective. METHODS: Literature review of papers dealing with ocular reference axes, angles, and centration. RESULTS: The inconsistent definitions and usage of the current ocular axes, as derived from eye models, limit their clinical utility. With a clear understanding of Purkinje images and a defined alignment of the observer, light source/fixation target, and subject eye, the subject-fixated coaxially sighted corneal light reflex can be a clinically useful reference marker. The axis formed by connecting the subject-fixated coaxially sighted corneal light reflex and the fixation point, the subject-fixated coaxially sighted corneal light reflex axis, is independent of pupillary dilation and phakic status of the eye. The relationship of the subject-fixated coaxially sighted corneal light reflex axis to a refined definition of the visual axis without reference to nodal points, the foveal-fixation axis, is discussed. The displacement between the subject-fixated coaxially sighted corneal light reflex and pupil center is described not by an angle, but by a chord, here termed chord mu. The application of the subject-fixated coaxially sighted corneal light reflex to the surgical centration of refractive treatments and devices is discussed. CONCLUSION: As a clinically defined reference marker, the subject-fixated coaxially sighted corneal light reflex avoids the shortcomings of current ocular axes for clinical application and may contribute to better consensus in the literature and improved patient outcomes.

Accuracy of intraocular lens power prediction using the Hoffer Q, Holladay 1, Holladay 2, and SRK/T formulas.

PURPOSE: To compare the accuracy of intraocular lens (IOL) power calculations using 4 formulas: Hoffer Q, Holladay 1, Holladay 2, and SRK/T. SETTING: Tertiary care center. METHODS: This study was a retrospective comparative analysis. Immersion ultrasound biometry (axial length, anterior chamber depth, and lens thickness), manual keratometry, and postoperative manifest refraction were obtained in 643 eyes of consecutive patients who had routine uneventful cataract surgery with implantation of 1 of 2 IOLs using the same operative technique by the same surgeon. Biometric data were entered into each of the 4 IOL power calculation formulas, and the results were compared to the final manifest refraction. An optimized lens constant was used for each formula. Results were also stratified into groups of short, average, medium long, and very long axial length <22.0 mm, 22.0 to <24.5 mm, 24.5 to 26.0 mm, and >26.0 mm, respectively). RESULTS: No formula was more accurate than the others as measured by mean absolute error. The formulas were also equally accurate when eyes were stratified by axial length. CONCLUSION: The 4 IOL power formulas provided equivalent refractive results in the entire group of eyes and in the subsets of axial lengths tested.

Phakic intraocular lenses.

PURPOSE OF REVIEW: Laser in-situ keratomileusis has been tremendously successful in treating patients with mild and moderate ametropias. For patients with high degrees of refractive error, however, phakic intraocular lenses provide superior quality of vision without the risk of corneal ectasia. Early international results, as well as United States Food and Drug Administration clinical trials, have demonstrated the early safety and efficacy of phakic intraocular lenses. Nevertheless, long-term corneal endothelium cell density and crystalline lens clarity remain a concern. RECENT FINDINGS: Several new studies demonstrate the superior visual outcomes of phakic intraocular lenses over laser in-situ keratomileusis in patients with moderate and high myopia, particularly in the areas of visual quality and contrast sensitivity. New anterior segment imaging and measurement technologies have provided valuable information about in-vivo structure and function, with and without phakic lens implants. More is being learned about long-term endothelial cell stability and cataract formation, particularly in relation to implant positioning. New applications of phakic intraocular lenses in presbyopia and in other conditions are being explored. SUMMARY: Once plagued by complications and marginal outcomes, improved designs of phakic intraocular lenses are providing increasing safety and efficacy for the correction of severe ametropias. Long-term concerns with endothelial cell loss remain, but recent data suggest stabilization with time. Proper sizing and positioning are important and increasingly achievable with new imaging modalities. With continued research and experience, phakic intraocular lenses are becoming an invaluable addition to the mainstream refractive surgery armamentarium.

Refractive surgery after corneal transplantation.

PURPOSE OF REVIEW: Many patients who have undergone corneal transplantation are unable to achieve satisfactory visual acuity with spectacle and contact lens correction alone. For these patients, refractive surgery becomes a viable option to reduce the post-keratoplasty ametropia. With the many recent advances in refractive surgery for naturally occurring refractive error, new possibilities arise for application to this complicated set of patients. This review discusses key recent developments in refractive surgery after corneal transplantation. RECENT FINDINGS: The biomechanical effects of incisional keratotomy on post-keratoplasty corneas continue to be studied, and these techniques remain a common and simple method of reducing astigmatism. Photorefractive keratectomy, previously problematic for regression and haze formation, is gaining new prominence as early experience with the adjunctive use of mitomycin C has demonstrated good results. Long-term studies with laser in-situ keratomileusis (LASIK) have continued to show good safety and efficacy. Modern developments in cataract surgery appear to have lower incidences of graft rejection and failure. Developments in lens implantation technology continue to offer expanding options for intraocular refractive surgery. SUMMARY: Although visual rehabilitation after corneal transplantation remains a formidable challenge, developments in refractive surgery for naturally occurring ametropias directly translate into an improved ability to help these most challenging refractive cases. Continued research will bring about improved efficacy while maintaining a high level of safety.

Change in intraocular pressure measurements after LASIK the effect of the refractive correction and the lamellar flap.

OBJECTIVE: To study the relationship between intraocular pressure (IOP) readings after LASIK and the amount of refractive correction. DESIGN: Retrospective noninterventional case series. PARTICIPANTS: Patients receiving primary LASIK for myopia and myopic astigmatism. METHODS: A database of preoperative, intraoperative, and 3-month postoperative data for 8113 consecutive eyes that underwent primary myopic and myopic astigmatic LASIK was retrospectively reviewed. Linear regression analysis of measured IOP change as a function of refractive change was then performed. Age and preoperative keratometry were also reviewed by multiple regression. MAIN OUTCOME MEASURES: Best-fit curve relating change in measured IOP to refractive change. RESULTS: The mean spherical equivalent of the refractive change was -4.98+/-2.64 diopters (mean +/- standard deviation). The mean decrease in measured IOP was 2.0+/-3.3 mmHg. Linear regression analysis revealed a decrease of 0.12 mmHg of measured IOP per diopter of refractive change (95% confidence interval [CI], 0.09-0.15, R(2) = 0.009, P<0.001). Extrapolation of the data to a theoretical correction of zero diopters revealed a decrease of 1.36 mmHg (95% CI, 1.20-1.51, P<0.001), suggesting a component of measured IOP change that is independent of laser ablation. CONCLUSIONS: The reduction of IOP readings after corneal refractive surgery is a linear function of the amount of refractive correction, with an additional constant reduction that is probably related to the lamellar corneal flap. These data suggest that the lamellar corneal flap makes no contribution to the load-bearing characteristics of the post-LASIK cornea.