Clinical Results of a Trifocal Toric Intraocular Lens Using the Holladay Total Surgically Induced Astigmatism Formula for Correcting Low Corneal Astigmatism in Japanese Patients.

Purpose: To evaluate the effectiveness and safety of the AcrySof IQ PanOptix toric intraocular lens (IOL) with cylinder power of 1.0 D (TFNT20) in a Japanese population with low corneal astigmatism and compare with historical control data for nontoric IOLs. Setting: Tokyo Dental College Suidobashi Hospital, Tokyo, Japan. Design: Prospective, single-center study. Methods: Patients ≥20 years old received TFNT20 IOL in at least 1 eye based on Alcon Toric calculator (Holladay Total surgically induced astigmatism). Effectiveness endpoints included the percentage of eyes with refractive cylinder ≤0.25 D at 30-60 days after surgery, which was compared with a historical control threshold rate of 29.2% for nontoric IOLs and refractive cylinder ≤0.50 D. Monocular uncorrected distance visual acuity (UDVA; 5 m), uncorrected intermediate visual acuity (UIVA; 60 cm), uncorrected near visual acuity (UNVA; 40 cm), and adverse events were evaluated. Results: Of 41 eyes implanted with TFNT20 IOLs, 37 eyes (90%) achieved refractive cylinder ≤0.25 D at 30-60 days after surgery, demonstrating the superiority of TFNT20 compared with historical data (P<0.0001). Refractive cylinder of ≤0.50 D was achieved by 41 eyes (100%). At 30-60 days, mean ± SD monocular CDVA was -0.15 ± 0.07 logMAR, UDVA was -0.09 ± 0.09 logMAR, UIVA was -0.00 ± 0.07 logMAR, and UNVA was 0.03 ± 0.07 logMAR. Six eyes (15%) had elevated postoperative intraocular pressure, which returned to normal and was not device-related. Conclusion: TFNT20 IOLs successfully reduced postoperative refractive cylinder and provided good distance, intermediate, and near uncorrected VAs in Japanese patients with low corneal astigmatism.

Clinical outcomes in eyes with diffractive continuous depth-of-focus intraocular lenses enhanced for near vision: comparison with trifocal intraocular lenses.

BACKGROUND: To prospectively evaluate visual functions and patient satisfaction after bilateral implantation of diffractive continuous depth-of-focus intraocular lens (CDF IOL) compared with trifocal IOLs. METHODS: This investigator-initiated study was approved by a certified local review board (registered: jRCTs032210305). CDF IOL (Synergy, J&J, group S) and trifocal IOL (AcrySof PanOptix, Alcon, group P) were implanted bilaterally in 30 patients each. Three months postoperatively, binocular outcomes of uncorrected (BUCVA) and distance-corrected (BDCVA) visual acuities at distances of 0.3, 0.4, 0.5, 0.7, and 5 m were measured. Contrast sensitivities were binocularly measured using CSV-1000 (2.5 m) and Pelli-Robson charts at distances of 0.4 and 1 m. Symptoms of glare, halo, starburst, and waxy vision, and satisfaction for near, intermediate, and far visions were assessed with questionnaires. Differences between the two groups were examined. RESULTS: Twenty-seven patients each completed the follow-up. The mean age of the group S was lower than that of the group P (P < 0.001). The BUCVA at 0.4 m was better in the S group, while the mean manifest refraction of the P group showed a significant hyperopic shift (P < 0.001). BDCVA was significantly better in the S group. The contrast sensitivity results at three distances showed no discernible differences. Although more patients in the S group reported significant glare and halo, their satisfaction with near vision was higher. CONCLUSIONS: The binocular visual function of patients with CDF IOLs was comparable to or better than that of patients with trifocal IOLs. The patients were satisfied with near vision, despite the enhanced glare and halo. Understanding the differences between the two types of presbyopia-correcting IOLs is important to ensure patient satisfaction. TRIAL REGISTRATION: This clinical trial was registered in the Japan Registry for Clinical Research (identifier: jRCTs032210305) on September 13, 2021.

Visual Function after Implantation of Diffractive Extended Depth-of-Focus Intraocular Lenses in Eyes with Primary Open-Angle Glaucoma.

INTRODUCTION: The aim of this prospective study was to compare the visual functions of extended depth-of-focus intraocular lenses (EDOF IOLs) and monofocal IOLs in eyes with mild to moderate primary open-angle glaucoma (POAG). METHODS: Cataractous eyes with POAG controlled using medical treatments, no central visual field defects, and mean deviation (MD) values of -10 dB or better on the 30-2 test grid of the Swedish Interactive Threshold Algorithm standard program were included. Twenty-two eyes of 22 patients received EDOF IOLs (ZXR00V and ZXV150-375; J&J), whereas 24 eyes of 24 patients received monofocal IOLs (ZCB00V and ZCV150-375; J&J). MD values, corrected distance visual acuity (CDVA), and photopic contrast sensitivity were measured at 3 months after surgery. Noninferiority of CDVA and contrast sensitivity in eyes with EDOF IOLs to eyes with monofocal IOLs were examined. RESULTS: The postoperative mean MDs of eyes with EDOF and monofocal IOLs were -2.76 dB and -4.21 dB with no significant difference. The CDVA of eyes with EDOF IOLs was noninferior to that of eyes with monofocal IOLs (P = 0.02). There were no inferiority in contrast sensitivity at any spatial frequency (P < 0.001). CONCLUSIONS: The visual function of EDOF IOLs in eyes with mild-to-moderate POAG was not inferior to that of monofocal IOLs. TRIAL REGISTRATION: Registered in the Japan Registry for Clinical Research (identifier: jRCTs032200218).

Implantation of diffractive extended depth-of-focus intraocular lenses in normal tension glaucoma eyes: A case series.

Purpose: Implantation of presbyopia-correcting intraocular lenses (IOLs) has not been advised for glaucomatous eyes because of the risk of decreased contrast sensitivity with progress of glaucoma. Extended depth-of-focus (EDF) IOLs have been reported to provide comparable postoperative visual function and influence on the visual field to monofocal IOLs. Methods: This case series was a retrospective medical record review of 16 eyes of 10 patients who had normal tension glaucoma (NTG) with no central visual field defects and underwent cataract surgery with implantation of diffractive EDF IOLs. At 3 months postoperatively, distance-corrected visual acuities (DCVAs) at distances of 5, 1, and 0.5 m and photopic contrast sensitivity were examined. Automated perimetry using the 30-2 Swedish interactive threshold algorithm was also performed, and the mean variance (MD) values, mean deviation values at the central four points (central MD), and foveal threshold were recorded. Results: The mean age of the patients (5 men, 5 women) was 66.5 years. Over 80% of eyes obtained DCVAs of 20/20, 20/20, and 20/25 at 5 m, 1 m, and 0.5 m, respectively. Whereas 5 of 16 eyes were categorized as severe by the Hodapp-Parrish-Anderson classification, postoperative contrast sensitivity was within the normal range, except for 4 eyes at 18 cycles per degree. Conclusions and importance: In this case series, the postoperative visual functions of NTG patients with EDF IOLs were almost comparable to those of normal eyes with the same IOLs, which demonstrated that the use of EDF IOLs for controlled NTG eyes would be permissible. While careful patient selection and follow-up for NTG progress are important, further investigations are necessary for confirming the safety and exploring the selection criteria.

Evaluations of bridging sutures in preventing iris capture in eyes with intrascleral fixation of implanted intraocular lens.

PURPOSE: The study aims to determine the effectiveness of bridging sutures in preventing iris capture and a subsequent reverse pupillary block after an intrascleral fixation of an implanted intraocular lens (IOL). METHODS: We studied 6 eyes that had an iris capture with reverse pupillary block due to a dislocated IOL after an intrascleral fixation. After the dislocated IOL was repositioned, 10-0 polypropylene sutures were inserted 1.5 mm posterior to the limbus and directed to run between the iris and the IOL. The sutures were placed orthogonal to the haptics of the IOL. Anterior segment optical coherence tomography (AS-OCT) was used in 4 eyes to evaluate the degree of iridodonesis before and after the bridging sutures. The heights of the temporal and nasal sectors of the middle iris from the iris plane (the line between anterior chamber angles) were compared for each 0.2-s AS-OCT image taken immediately after the eye moved from a lateral to a primary position. RESULTS: None of the eyes had a recurrence of the iris capture after the bridging sutures. The refractive error, anterior chamber depth, and vision were not significantly altered after the bridging sutures were placed. The AS-OCT images showed that the height of the nasal iris was decreased more at 0 s postoperatively blocking the excessive downward movement of the nasal iris but not the iridodonesis. CONCLUSION: Bridging sutures were effective in preventing iris capture and subsequent reverse pupillary block after an intrascleral fixation of an IOL.

Subjective and objective refractions in eyes with extended-depth-of-focus intraocular lenses using echelette optics: clinical and experimental study.

PURPOSE: To evaluate differences in subjective and objective refractions in eyes with extended-depth-of-focus intraocular lenses (EDOF IOLs) using echelette optics, and the effect of the light wavelength used during examinations. METHODS: In the prospective study, subjective and objective refractions of 128 eyes of 64 patients were examined 3 months after implantation of the EDOF IOLs (ZXR00V, Johnson & Johnson Surgival Vision). Objective refractions were measured using an autorefractor with a near-infrared (NIR) light source. Clinical differences in the spherical, cylindrical and spherical equivalent (SE) refractions between the subjective and objective refractions were evaluated. Then, lens powers of monofocal, EDOF and diffractive bifocal IOLs in the use of a 850-nm light source were measured experimentally for using a lensmeter, and the differences from the monofocal IOLs were calculated. RESULTS: The mean objective refractions were more myopic (p < 0.001) than the subjective refractions; the differences in the spherical, cylindrical and SE refractions were -0.71, -0.26 and -0.84 dioptre, respectively. Experimental investigation resulted that there was the mean difference of 0.83 D with the EDOF from monofocal IOLs at 850 nm, while the difference was -0.20 D with bifocal IOLs. CONCLUSIONS: The diffractive EDOF IOLs using echelette gratings inherently induced constant differences in the subjective and objective refractions, which arose from the chromatic difference in IOL powers for the visible and NIR lights.

Efficacy of Femtosecond Laser-Assisted Capsulotomy: Experimental Evaluation Using the Zonular Dehiscence Model.

Purpose: The purpose of this study was to evaluate experimentally the efficacy of femtosecond laser (FL)-assisted capsulotomy using an eye model with different degrees of zonular dehiscence (ZD). Methods: An eye model with ZD was created by removing the total iris and including the planned range of the ZD in porcine and human cadaver eyes. FL-assisted capsulotomies (laser group) and manual capsulotomies (manual group) were created for the eye model with 0, 45, 135, 180, and 270 degrees of ZD. The continuity, mean diameter, ellipticity, and decentration of the capsulotomy were evaluated using the captured images. The same evaluation of FL-assisted capsulotomies was done for five human cadaver eyes with 180 degrees of ZD. Results: In the laser group, no differences were seen in the mean diameter, ellipticity, and decentration, although the manual group resulted in significantly larger, ovalized, and decentered capsulotomies with different degrees of ZD (P < 0.001, P < 0.001, and P = 0.0317, respectively). Continuous capsulotomies or capsulotomies with microadhesions were obtained up to 180 degrees of ZD, and incomplete treatment areas were seen in eyes with 270 degrees of ZD. Capsulotomy of the human cadaver eyes with 180 degrees of ZD showed similar results to those of porcine eyes. Conclusions: In this experimental study, FL-assisted capsulotomy showed favorable results in eyes with between 0 and 180 degrees of ZD compared to conventional manual capsulotomy. Translational Relevance: Our experimental model can simulate the capsulotomy in cases with ZD, the results are useful when determining the indication for FL-assisted capsulotomies.

Binocular visual function after staged implantation of extended-depth-of-focus intraocular lens targeting emmetropia and -0.5 diopter: A prospective comparison.

The prospective comparative case series aimed to evaluate the binocular uncorrected visual acuities (BUCVAs) after staged implantations of extended-depth-of-focus intraocular lenses (EDOF IOLs) targeting emmetropia and -0.5 diopter (D). Diffractive EDOF IOLs with an add power of +1.75 D were implanted in the first eyes targeting emmetropia or -0.5 D according to the patients' preferences, then the targets for the second eyes were determined 1 week or longer after the implantation. IOL powers were determined with the SRK/T formula. Consequently, the subjects were divided into 3 groups: those with emmetropia targeted bilaterally (group EE, 22 patients), those with -0.5 D targeted bilaterally (group MM, 21 patients), and those with monovision of emmetropia and -0.5 D (group EM, 21 patients). Manifest refraction spherical equivalent (MRSE), BUCVA from 0.3 to 5 meters, spectacle use, and questionnaire regarding photic symptoms and patient satisfaction were assessed 3 months postoperatively. No significant differences were seen in the mean BUCVAs at any distance (P > 0.23), spectacle use (P = 0.13), or photic symptoms and patient satisfaction (P>0.65). When the EE and MM groups were assigned based on the MRSE, the EE group was better at 5 m (P = 0.005) while the MM group at 0.5 m (P = 0.031). The effect of different targeted refractions was not identified due to insufficient accuracy in the use of the SRK/T power calculation.

Results of a clinical evaluation of a trifocal intraocular lens in Japan.

PURPOSE: To evaluate the effectiveness and safety of a new trifocal intraocular lens (IOL) after cataract removal in patients living in Japan. STUDY DESIGN: Prospective multicenter clinical study. METHODS: One hundred and thirty-five eyes of 68 patients (19 men, 49 women; mean age, 66.3 ± 7.4 years) were followed for 6 months. Trifocal IOLs with focal points at near, intermediate, and distance were implanted bilaterally in eyes with less than 1 diopter of corneal astigmatism. The visual acuity (VA) at distance, 60 and 40 centimeters (cm), and contrast sensitivities were measured. Patients completed quality-of-life questionnaires preoperatively and postoperatively. RESULTS: The mean bilateral logarithm of the minimum angle of resolution VA at 5 meters (m), 60 cm, and 40 cm were, respectively: uncorrected, - 0.104 ± 0.095, - 0.065 ± 0.111, and - 0.042 ± 0.105; and distance-corrected, - 0.197 ± 0.076, - 0.112 ± 0.111, and - 0.073 ± 0.111. The contrast sensitivities at distance and near were within the normal range at all spatial frequencies under photopic conditions. Patients reported complete spectacle independence in 75.0% of cases. Total use of spectacles was reported by 1.5% and partial by 20.6%; the purpose of spectacle use was primarily for near visual tasks. Mild-to-moderate glare was reported by 65.7% of patients and halos by 70.1%; only 1.5% of subjects reported severe glare and halos. CONCLUSIONS: This new trifocal IOL provides equally good uncorrected VAs at distance, intermediate, and near, and decreases spectacle dependence in daily life. Patients frequently report mild-to-moderate glare and halos, and patients should be informed about these before implantation.

Binocular Visual Function With Staged Implantation of Diffractive Multifocal Intraocular Lenses With Three Add Powers.

PURPOSE: To evaluate the binocular visual function and depth of focus after staged implantation of diffractive multifocal intraocular lenses (MIOLs) with 3 different add powers following cataract removal. DESIGN: Prospective comparative case series. METHODS: Setting: Institutional. STUDY POPULATION: Both eyes of 56 patients that underwent staged implantation of bifocal IOLs. INTERVENTION: In the first eye, MIOLs with a +4.0-diopter (D) add power were implanted. Based on outcomes at 1 week postoperatively and patient preference for near vision, 1 of 3 near add powers-+4.0 D (group MM), +3.25 D (group ML), or +2.75 D (group MK)-was implanted in the fellow eye. MAIN OUTCOME MEASURE(S): Three months postoperatively, the binocular uncorrected and distance-corrected visual acuities (BUCVA and BDCVA, respectively) at 5.0, 1.0, 0.5, 0.4, and 0.3 meters; binocular defocus curves; contrast sensitivity; and near stereopsis were measured. RESULTS: The MM, ML, and MK groups included 21, 18, and 17 patients, respectively. The mean BUCVA in the MM group was significantly (P = .003) worse than that in the MK group at 0.5 meter. The BDCVAs at 0.5 meter in the ML and MK groups were significantly (P < .02) better than that in the MM group. The defocus curves with the -2.0 D refraction differed significantly (P < .001) between the MM and MK groups. The binocular contrast sensitivity and stereopsis values did not differ significantly. CONCLUSIONS: Staged implantation of different add powers obtained better binocular intermediate visual acuity without degradation of visual function.

The Efficacy of Transcorneal Electrical Stimulation for the Treatment of Primary Open-angle Glaucoma: A Pilot Study.

The aim of this study was to evaluate the effects of transcorneal electrical stimulation in subjects with primary open-angle glaucoma. Five eyes of four male subjects with primary open-angle glaucoma (average age: 52.25 ± 14.68 years) were enrolled. The subjects underwent transcorneal electrical stimulation every 3 months according to the following procedure. A Dawson-Trick-Litzkow electrode was placed on the cornea, and biphasic electric current pulses (10 ms, 20 Hz) were delivered using a stimulator (BPG-1,BAK Electronics) and a stimulus isolation unit (BSI-2). A current that evoked a phosphene that the subject perceived in the whole visual area was delivered continuously for 30 min. Humphrey visual field testing was performed after every third transcorneal electrical stimulation treatment. Changes in mean deviation (MD) values were evaluated with a linear regression model. Transcorneal electrical stimulation was performed 18.2 ± 9.4 times over a period of 49.8 ± 23.0 months. The average pretranscorneal electrical stimulation intraocular pressure, best corrected visual acuity, and MD values were 11.8 ± 1.79 mmHg, 0.14 ± 0.19 (logMAR) and -17.28 ± 6.24 dB, respectively. No significant differences were observed in intraocular pressure before and after transcorneal electrical stimulation. However, there was a significant positive linear relationship between changes in MD values and the number of transcorneal electrical stimulation treatments (R2 = 0.176, P = 0.005, Spearman correlation R =0.294, P = 0.008). Transcorneal electrical stimulation treatment may improve glaucomatous visual field defects in subjects with primary open-angle glaucoma. Large-scale studies are necessary to confirm these preliminary findings.

Safety and reliability of femtosecond laser-assisted cataract surgery for Japanese eyes.

PURPOSE: To assess the safety and efficacy of femtosecond laser-assisted cataract surgery (FLACS) in Japanese eyes. STUDY DESIGN: Retrospective case series. METHODS: The clinical records of 529 consecutive eyes of 312 Japanese patients who underwent FLACS from 2013 to 2016 were reviewed. The completion rates of anterior capsulotomy and corneal incisions using the femtosecond laser (LenSx, Alcon) and the number of attempts to achieve secure docking between the cornea and laser system were recorded. The uncorrected and corrected distance visual acuities (VAs) and uncorrected and distance-corrected near VAs 1 week postoperatively were evaluated. RESULTS: Anterior capsulotomies were completed in 98.7% of eyes. The corneal incisions were incomplete in 8.3%, which included eyes with arcus senilis and neovascularization. The mean corneal endothelial cell reduction rate was 5.5%. Multiple docking attempts were required in 22.9% of eyes, while canthotomy was performed in two eyes. The postoperative VAs were favorable. CONCLUSION: FLACS was safe and reliable in Japanese eyes. Further improvements in docking are required to accommodate small corneas and narrow palpebral spaces.

Process design of chondrocyte cultures with monolayer growth for cell expansion and subsequent three-dimensional growth for production of cultured cartilage.

The subculture of rabbit chondrocytes with serial passaging was carried out for cell expansion on a collagen-coated surface, and the morphological transition of round-shaped cells to spindle-shaped ones was examined. The observation of cytoskeletal formation by staining F-actin and vinculin supported the view that the round-shaped cells were in the process of differentiation with immature stress fibers relating to less cellular polarity. The cellular morphology was estimated in terms of the distribution of roundness, R(C), during the subculturing on the collagen substrate. The frequency of the number of round-shaped cells, which was defined as the ratio of the number of cells with R(C) >0.9 against the total cell number, was correlated in a logarithmic formula with the number of population doublings during the subcultures. Kinetic models were adopted for the process design of the combined culture of chondrocytes with monolayer growth on the collagen substrate and subsequent three-dimensional growth in Atelocollagen gel, employing the boundary conditions based on the population balance between differentiated and dedifferentiated cells. The combined culture was performed successfully according to the process design scheduled as monolayer growth for 240 h and three-dimensional growth for 264 h, the number of seed cells being 68% of that in the conventional culture for 504 h where monolayer growth for cell expansion was not included.

Subculture of chondrocytes on a collagen type I-coated substrate with suppressed cellular dedifferentiation.

To evaluate the degree of cellular dedifferentiation, subculture of chondrocytes was conducted on a surface coated with collagen type I at a density of 1.05 mg/cm(2). In the primary culture, most of the cells were round in shape on the collagen (CL) substrate, whereas fibroblastic and partially extended cells were dominant on the polystyrene plastic (PS) substrate. Stereoscopic observation revealed that the round-shaped cells on the CL substrate were hemispherical with nebulous and punctuated F-actin filaments, whereas the fibroblastic cells on the PS substrate were flattened with fully developed stress fibers. This suggested that cell polarization was suppressed during culture on the former substrate. Although serial passages of chondrocytes through subcultures on the CL and PS substrates caused a decrease in the number of round-shaped cells, the morphological change was appreciably suppressed on the CL substrate, as compared with that on the PS substrate. It was found that only round-shaped cells formed collagen type II, which supports the view that cellular dedifferentiation can be suppressed to some extent on the CL substrate. Three-dimensional cultures in collagen gel were performed with cells isolated freshly and passaged on the CL or PS substrate. Cell density at 21 days in the culture of cells passaged on the CL substrate was comparable to that in the culture of freshly isolated cells, in spite of a significant reduction in cell density observed in the culture of cells passaged on the PS substrate. In addition, histological analysis revealed that the expression of glycosaminoglycans and collagen type II was of significance in the collagen gel with cells passaged on the CL substrate, and likewise in the gel with freshly isolated cells. This indicated that the CL substrate could offer a monolayer culture system for expanding chondrocyte cells.