Enhanced ICL Sizing Accuracy Using Advanced Optical Coherence Tomography-Based Predictive Formula.

PURPOSE: The aim of this study was to evaluate the accuracy of existing implantable collamer lens (ICL) sizing formulas, specifically the NK and KS formulas using CASIA2 and ANTERION devices, and to introduce a novel method aimed at improving the predictability of postoperative vault outcomes. DESIGN: Retrospective case series. METHODS: Preoperative measurements were taken using both CASIA2 and ANTERION devices. The efficacy of the NK and KS formulas, which are integrated into CASIA2, was assessed by comparing their predicted vault values against actual postoperative measurements obtained one month after surgery. A stepwise multiple regression analysis was performed with the aim of developing a new, more accurate predictive formula for optimal ICL sizing. RESULTS: When compared to the existing NK and KS formulas, the new formula developed from ANTERION measurements demonstrated superior accuracy in predicting optimal ICL size, with a mean vault of 0.535±0.200 mm, compared to 0.419±0.172 mm and 0.466±0.103 mm for the NK and KS formulas, respectively. The regression analysis identified several significant parameters influencing the determination of optimal ICL size. CONCLUSIONS: This study presents a novel formula for ICL sizing that leverages measurements from the ANTERION device, supported by a detailed multiple regression analysis. The findings suggest that this new approach significantly enhances the accuracy of ICL size prediction, potentially reducing the risk of complications associated with improper sizing.

Multicenter clinical outcomes of hole implantable collamer lens implantation in middle-aged patients.

To assess the multicenter clinical outcomes of the implantation of hole implantable collamer lens (Hole ICL, ICL KS-AquaPORTTM; STAAR Surgical, Nidau, Switzerland) in patients of 45 years or more. We retrospectively assessed the surgery's safety, efficacy, predictability, stability, and adverse events before surgery and after the surgery at 1 week; 1, 3, and 6 months; and 1 year, followed by once every year for approximately 2.2 years. A total of 118 eyes of 65 patients aged 45-65 years with myopic refractive errors ranging from - 2.13 to - 18.75 diopters (D) underwent hole ICL implantation and routine postoperative examinations. The average observation period was 2.2 ± 1.0 years. The safety and efficacy indices were 1.08 ±  0.21 and 0.87 ± 0.25, respectively. Manifest refraction changes of - 0.20 ± 0.43 D occurred from 1 month to the final visit after ICL implantation. Eight eyes (6.8%) developed asymptomatic anterior subcapsular cataract (ASC) immediately after surgery, and three eyes (2.5%) developed clinically significant symptomatic nuclear cataracts during the follow-up period. According to our experience, hole ICL implantation offered favorable outcomes in all measures of safety, efficacy, predictability, and stability, even in middle-aged patients, during the 2.2-year observation period.

Multicenter survey on implantable collamer lens dislocation.

This study aimed to investigate the incidence, patient background, and postoperative prognosis of implantable collamer lens (ICL) dislocation. We retrospectively reviewed all cases of ICL dislocation at four major refractive surgery centers in Japan until December 2019. The incidence, patient background, cause of dislocation, complications of repositioning surgery, and postoperative visual function were investigated. Seven ICL dislocations [0.072% of total ICL-implanted eyes (9775 eyes)] occurred at an average of 28.6 months (11-82 months) postoperatively. All patients were male. Five eyes were injured during sports activities, one due to a fall from a bicycle, and another due to ocular blunt trauma caused by a mortuary tablet. Two patients had re-dislocation in the same eye. Retinal detachment occurred after repositioning surgery in one patient, and scleral buckling surgery was performed without ICL removal. ICL dislocation is a rare complication of ICL surgery; repositioning surgery is effective, but retinal complications may occur.

Assessment of the Vault After Implantable Collamer Lens Implantation Using the KS Formula.

PURPOSE: To examine the vault size after Implantable Collamer Lens (ICL) (KS-AquaPORT; STAAR Surgical) surgery using the KS formula. METHODS: In this prospective study, the postoperative vault was examined using the KS formula in 121 eyes of 65 patients (28 men and 37 women) who underwent ICL implantation for myopia and myopic astigmatism. The mean horizontal angle-to-angle (ATA), anterior chamber depth, and axial length before surgery were 11.83 ± 0.40, 3.25 ± 0.34, and 26.52 ± 1.17, respectively. Anterior segment optical coherence tomography (CASIA2; Tomey Corporation) was used for ATA measurement. RESULTS: Multiple regression analysis of the potential factors influencing the predicted vault error (postoperative vault - predicted vault by KS formula) showed that only ICL size was a significant factor (P < .001, r = 0.36). At an ICL size of 12.1 mm, the postoperative vault was smaller than the predicted vault, and the postoperative vault tended to be larger than the predicted vault at ICL sizes of 13.2 and 13.7 mm. CONCLUSIONS: Vault prediction by the KS formula was generally good, but the ICL size influenced the vault prediction error; therefore, a modified KS formula was created to reduce the error in measurements of the postoperative vault. [J Refract Surg. 2021;37(9):636-641.].

Assessment of low-vault cases with an implantable collamer lens.

This study aimed to examine clinical results in low-vault eyes after implementation of a Hole implantable collamer lens (KS-AquaPORT™, STAAR Surgical Company) in terms of visual outcomes and complications over a one-year follow-up period. This was a retrospective cohort study of subjects who underwent Hole implantable collamer lens surgery at Sanno Hospital, exhibited low vault, and were followed up for 1 year. Patients were included if they met the following criteria: 20≤ age ≤55 years; stable refraction ≥6 months; -1.0 to -20.0 diopters of myopia; endothelial cell density ≥1800 cells/mm2; and no history of ocular surgery, progressive corneal degeneration, cataract, glaucoma, or uveitis. Main outcome measurements were the safety and efficacy indices, predictability, and vault. Values were indicated as the mean ± standard deviation. Subjects included 16 patients (age: 38 ± 8 years; 6 males; 25 eyes). Toric lenses were utilized for 10 eyes. Implantable collamer lens size was 12.1, 12.6, and 13.2 mm for 18, 6, and 1 eye(s), respectively. One year postoperatively, the safety index was 1.07; for 22 eyes with a target refraction of that of emmetropic eyes, the efficacy index was 0.90; and 96% of eyes were within ± 0.50 diopters of attempted versus achieved spherical equivalent correction. Postoperative vault was 142 ± 60 µm. One year postoperatively, no additional surgery was required for rotation of toric implantable collamer lens, and no advanced cataracts, increased intraocular pressure, or decreased endothelial cells were observed. In conclusion, Hole implantable collamer lens yielded satisfactory visual outcomes and no postoperative complications for low-vault eyes, suggesting its suitability for such cases.

Kinetic visual acuity, stereopsis, and ocular deviation with an implantable collamer lens.

PURPOSE: To compare kinetic visual acuity, stereopsis, ocular deviation, and fusion amplitude before and after implantable collamer lens (ICL) surgery. SETTING: Sanno Hospital. DESIGN: Retrospective analysis. METHODS: The charts of adult patients who underwent implantation of an ICL with a central aquaport (V4c) for emmetropia were reviewed. The mean preoperative spherical equivalent and subjective astigmatism were -7.87 diopters (D) ± 3.13 (SD) and -0.75 ± 0.78 D, respectively. All measurements were obtained with full refraction before surgery and without spectacle correction after surgery. The kinetic visual acuity was measured with the AS-4D device. Stereopsis and ocular deviation were measured with the Titmus Stereotest and an alternate prism cover test, respectively. Fusion amplitude was determined from breakpoints measured using a prism. RESULTS: The study comprised 29 adult patients (58 eyes). One month postoperatively, the mean safety and efficacy indices were 1.13 ± 0.20 and 0.96 ± 0.25, respectively, and 57 eyes (98.7%) were within ±0.5 D of the target correction. The mean kinetic visual acuity (logarithm of the minimum angle of resolution) was 0.30 ± 0.21 preoperatively and 0.20 ± 0.15 (Snellen 20/40 versus 20/32) postoperatively and the mean stereopsis (seconds of arc), 48.5 ± 1.6 versus 41.5 ± 1.1; both improved significantly (P < .001 and P = .012, respectively). The mean distance ocular deviation (-4.0 ± 3.8 prism diopters [Δ] versus 2.8 ± 3.6 Δ; P = .002) and near ocular deviation (-6.5 ± 6.7 Δ versus 5.4 ± 6.9 Δ; P = .04) decreased significantly. The fusion amplitude increased for near vision only. CONCLUSIONS: ICL implantation improved kinetic visual acuity and stereopsis, decreased ocular deviation, and increased near fusion amplitude.

Relationship between Crystalline Lens Thickness and Shape and the Identification of Anterior Ocular Segment Parameters for Predicting the Intraocular Lens Position after Cataract Surgery.

PURPOSE: This study was performed to investigate the relationships among crystalline lens shape, actual intraocular lens (IOL) position, and crystalline lens thickness (LT), as measured by anterior segment optical coherence tomography (AS-OCT), and to determine anterior ocular segment parameters that predict postoperative IOL position. METHODS: Seventy-nine eyes of 79 patients who underwent uneventful cataract surgery were enrolled. For crystalline lens preoperative anterior segment data, the LT, and anterior, equatorial, and posterior surface depths (ASD, ESD, and PSD, respectively) of crystalline lenses were quantitatively determined. For postoperative anterior segment data, the actual IOL position was quantified. Moreover, the following correlations were analyzed: LT with the ASD, ESD, PSD, and IOL position; IOL position with the ASD, ESD, and PSD; and refractive prediction error with the difference between the predicted postoperative anterior chamber depth (ACD) of the SRK/T formula and the IOL position, ASD, ESD, and PSD (each depth minus the predicted postoperative ACD of the SRK/T formula). RESULTS: The LT was significantly correlated with the ASD (r = -0.65) and PSD (r = 0.41), whereas it was not correlated with the ESD or IOL position. The IOL position was significantly correlated with the ASD (r = 0.67), ESD (r = 0.72), and PSD (r = 0.74). The refractive prediction error was significantly correlated with the difference between the predicted postoperative ACD of the SRK/T formula and the IOL position (r = 0.65), ASD (r = 0.46), ESD (r = 0.54), and PSD (r = 0.58). CONCLUSIONS: The ESD and PSD obtained using AS-OCT were highly correlated with the IOL position and significantly correlated with the refractive prediction error. These findings suggest that the ESD and PSD may enhance the accuracy of actual IOL position prediction.

Predictability of the vault after posterior chamber phakic intraocular lens implantation using anterior segment optical coherence tomography.

PURPOSE: To determine whether vault measurements after placement of a hole implantable collamer lens (hole ICL) (KS-AquaPORT) can be predicted by angle-to-angle (ATA) and white-to-white (WTW) measurements obtained with anterior segment optical coherence tomography (AS-OCT). SETTING: Sanno Hospital, Tokyo, Japan. DESIGN: Retrospective case series. METHODS: Eyes were observed for 3 months after hole ICL implantation for myopia or myopic astigmatism. Central vault, ATA, and WTW measurements were obtained before and after surgery using the swept-source AS-OCT CASIA2 system. RESULTS: The study included 44 eyes (23 patients). The mean patient age and preoperative spherical equivalent, ATA, and WTW values were 36.2 years ± 8.8 (SD), -6.23 ± 3.41 diopters (D), 12.03 ± 0.40 mm, and 11.72 ± 0.40 mm, respectively. The safety index and efficacy index 3 months postoperatively were 1.13 ± 0.21 and 0.91 ± 0.30, respectively. Regarding predictability, 93.2% of eyes were within ±0.50 D of the attempted correction and all eyes were within ±1.00 D. The reproducibility coefficients for the ATA distance and WTW distance were 0.998 and 0.960, respectively. The mean postoperative central vault was 491.6 ± 189.5 µm. There was a significant correlation between postoperative vault and the ICL size and ATA distance (Spearman rank correlation coefficient r = 0.59, P < .001) but not between the ICL size and WTW distance (r = 0.27, P = .08). CONCLUSION: The ATA measurements had higher reproducibility than the WTW measurements on AS-OCT, making it is a more important predictor of postoperative vault.

Visual Performance in Eyes Undergoing Femtosecond Laser-Assisted Keratoplasty for Advanced Keratoconus.

This study was aimed to compare visual performance in eyes having femtosecond laser-assisted keratoplasty (FLAK) for grade 4 keratoconus and keratoconic eyes according to the Amsler-Krumeich classification. We comprised 15 eyes of 15 patients undergoing FLAK for grade 4 keratoconus and 69 of 69 keratoconic patients (grade 1; 26 eyes, 2; 17 eyes, 3; 10 eyes, and 4; 16 eyes), and compared best spectacle-corrected visual acuity (BSCVA), corneal astigmatism (CA), corneal densitometry (CD), and corneal higher-order aberrations (CHOAs) using the Scheimpflug rotating camera. BSCVA in the post-FLAK group was significantly better than that in grade 3 or 4 group, but not than that in grade 1 or 2 group. CA was significantly lower than that in grade 3 or 4 group, but not than that in grade 1 or 2 group. CD was significantly higher than that in grade 1, 2, and 3 group, and significantly lower than that in grade 4 group. CHOAs were significantly lower than that in grade 3 or 4 group, but not than that in grade 1 or 2 group. FLAK showed significantly better BSCVA, and less CA and CHOAs, than grade 3 or 4 keratoconus, and showed less CD than grade 4 keratoconus.

Prediction of pupil size under binocular open-view settings using the new CASIA2 device.

PURPOSE: Pupillometry should be performed under conditions as close to natural viewing as possible. The present study aimed to determine whether pupil size in binocular open-view settings can be predicted based on pupil size measured using the CASIA2 device. METHODS: The present study included 61 participants (25 men and 36 women; mean age, 49 ± 15 years; age range, 22-69 years) with no history of ophthalmic disease other than refractive errors and cataract. We measured pupil size using the new CASIA2 device and a binocular open-view digital pupillometer (FP-10000II, TMI Co., Ltd., Saitama). Intra-class and inter-class reliabilities were evaluated by measuring pupil times three times with each device (two independent examiners) in 21 of the 61 participants. Reproducibility was analyzed using intra-class and inter-class correlation coefficients (ICCs). Regression formulae for calculating FP10000II pupil size based on CASIA2 pupil size were developed via simple linear regression analyses. RESULTS: Both devices exhibited high ICC values (> 0.80). The regression formulae for calculating the FP10000II pupil size for the distant and near views based on CASIA2 pupil size were y = 0.5702x + 0.4611 (determination coefficient, 0.67) and y = 0.502x + 0.445 (determination coefficient, 0.64), respectively. CONCLUSIONS: Pupil size under binocular open-view settings can be predicted based on simultaneous measurement of pupil size during evaluation of the anterior segment using the CASIA2 device. The calculated pupil size may represent a useful index for determining the most appropriate treatment strategy in candidates for cataract and refractive surgery.

Prospective Randomized Multicenter Comparison of the Clinical Outcomes of V4c and V5 Implantable Collamer Lenses: A Contralateral Eye Study.

PURPOSE: To compare the visual and refractive outcomes and night vision performance questionnaire results between V4c and V5 implantable Collamer lenses in a prospective, randomized, multicenter study. SETTINGS: Four refractive surgery centers. DESIGN: Prospective randomized multicenter single-masked comparative study. METHODS: Twenty-three patients were enrolled in this study. A conventional V4c model (EVO Visian ICL) was implanted in one eye, and a V5 model (EVO+ Visian ICL), which has a larger optic diameter than the V4c model, was implanted in the contralateral eye. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were evaluated before and 6 months after surgery. At 6 months after surgery, a questionnaire on night vision disturbances was administered. The efficacy, safety, and predictability of the two implanted ICL models were compared. RESULTS: There were no significant differences in the postoperative UDVA and CDVA between the two ICL models. The mean efficacy indexes for the V4c and V5 lenses were 1.16 ± 0.22 and 1.03 ± 0.23, respectively. The mean safety indexes of the V4c and V5 lenses were 1.21 ± 0.20 and 1.19 ± 0.20, respectively. The night vision performance questionnaire revealed that 7 patients (37%) noticed a difference in visual performance between the eyes, and all of them reported that they could see better at night with the V5-implanted eye compared with the V4c-implanted eye. CONCLUSION: The V4c and V5 ICL models achieved similar visual and refractive outcomes, whereas the V5 model showed a possible advantage in reducing night vision disturbances.

Intentional Undercorrection by Implantation of Posterior Chamber Phakic Intraocular Lens With A Central Hole (Hole ICL) For Early Presbyopia.

PURPOSE: To assess visual performance at near to far distances in early presbyopic patients with undercorrection by implantation of an ICL with a central hole (hole ICL). METHODS: This prospective study evaluated forty-two eyes of 21 early presbyopic patients (age, 40 to 53 years) with spherical equivalents of -7.37 ± 3.18 D [mean ± standard deviation] who underwent hole ICL implantation and whose targeted refraction was set at slight myopia (-0.61 ± 0.28 D) for both eyes. We assessed the safety, efficacy at near to far distances, predictability, and adverse events of the surgery, during the 6-month observation period. RESULTS: Corrected distance visual acuity did not improve significantly, from -0.17 ± 0.07 preoperatively to -0.19 ± 0.08 logMAR postoperatively (p=0.066, Wilcoxon signed-rank test). Uncorrected distance visual acuity was significantly improved from 1.30 ± 0.24 preoperatively to -0.03 ± 0.20 logMAR postoperatively (p<0.001). The mean binocular visual acuity was 0.02 logMAR or better at all distances (5.0, 3.0, 2.0, 1.0, 0.7, 0.5, and 0.3 m). All eyes were within ± 0.5 D of the targeted correction. Neither cataract formation, significant intraocular pressure rise, nor other vision-threatening complications occurred in any case during the 6-month observation period. CONCLUSIONS: Our pilot study showed that intentional undercorrection by hole ICL implantation for early presbyopia was safe with predictable refractive results and provided good binocular vision at near to far distances, without developing cataract, suggesting its viability as a surgical presbyopic treatment for such patients.

A Multicenter Retrospective Survey of Refractive Surgery in 78,248 Eyes.

PURPOSE: To retrospectively evaluate the current practice, trends, and outcomes of refractive surgery in Japan. METHODS: This multicenter survey comprised 78,248 eyes of 39,727 consecutive patients who underwent refractive surgery at 45 major institutions in Japan. The corresponding ophthalmologists responded to a selfadministered questionnaire. The authors especially evaluated the safety, efficacy, predictability, stability, and adverse events of LASIK and phakic intraocular lens (IOL) implantation 3 months postoperatively. RESULTS: The most common refractive surgery was LASIK (90.9%), followed by corneal inlay (5.0%), posterior chamber phakic IOL implantation (1.3%), laser-assisted subepithelial keratomileusis (1.0%), refractive lens exchange (0.9%), photorefractive keratectomy (0.3%), and refractive lenticule extraction (0.2%). For subgroup analysis, 69,987 eyes (99.5%) and 67,512 eyes (95.9%) achieved corrected and uncorrected distance visual acuity of 20/20 or better, respectively, after LASIK, and 935 eyes (98.8%) and 890 eyes (94.1%), respectively, after phakic IOL implantation. There were 69,176 eyes (98.3%) and 908 eyes (96.0%) within ±1.00 diopter (D) of the attempted correction after LASIK and phakic IOL implantation, respectively. There were 1,926 eyes (2.7%) and 1 eye (0.1%) with changes in refraction of 1.00 D or less from 1 week to 3 months after LASIK and phakic IOL implantation, respectively. No vision-threatening complications occurred in any case. CONCLUSIONS: According to this survey, LASIK remains the most prevalent surgical technique in Japan. Both LASIK and phakic IOL implantation offered good safety and efficacy outcomes, yielding predictable and stable results. [J Refract Surg. 2017;33(9):598-602.].

Comparison of corneal endothelial cell density and morphology after posterior chamber phakic intraocular lens implantation with and without a central hole.

AIM: To compare the corneal endothelial cells after posterior chamber phakic intraocular lens with and without a central hole (hole implantable collamer lens (ICL) and conventional ICL) implantation for the correction of moderate to high myopia. METHODS: This retrospective study evaluated 34 eyes of 34 patients who underwent hole ICL implantation and 25 eyes of 25 patients who underwent conventional ICL implantation. Preoperatively and 3 months, and 1 and 2 years postoperatively, we compared the central corneal endothelial cell density (ECD), coefficient of variation in cell size (CV) and the percentage of hexagonal cells (HEX) between the two groups using a non-contact specular microscope (EM-3000, Tomey). Preoperatively and 2 years postoperatively, we also compared them in the peripheral regions. RESULTS: The mean central ECD loss was 0.3% and 1.1%, 2 years after hole ICL and conventional ICL implantation, respectively (Mann-Whitney U test, p=0.72). There were no significant changes in central ECD, CV or HEX at any time points either after hole ICL or conventional ICL implantation, and a significant decrease only in terms of ECD in the superior regions after conventional ICL implantation. CONCLUSIONS: Both ICLs do not induce a significant change in the density, polymegethism or polymorphism of corneal endothelial cells even 2 years postoperatively, except for the density in the superior regions after conventional ICL implantation. However, hole ICL implantation may have advantages over conventional ICL implantation only in terms of the density in the superior regions, possibly because preoperative laser iridotomies are unnecessary.

A Multicenter Prospective Cohort Study on Refractive Surgery in 15 011 Eyes.

PURPOSE: To assess the clinical outcomes of currently used refractive surgery procedures performed in 2015. DESIGN: Prospective, multicenter cohort study. METHODS: This prospective study included 15 011 eyes of 7622 consecutive patients who underwent laser in situ keratomileusis (LASIK), surface ablation, refractive lenticule extraction (ReLEx), or phakic intraocular lens (IOL) implantation at 42 major institutions. We determined the safety, efficacy, predictability, stability, and adverse events of these surgeries preoperatively and at 1 week and 1 and 3 months postoperatively. RESULTS: Mean logMAR corrected distance visual acuity 3 months after LASIK, surface ablation, ReLEx, posterior chamber phakic IOL, or iris-supported phakic IOL implantation was -0.18 ± 0.07, -0.16 ± 0.08, -0.17 ± 0.09, -0.21 ± 0.08, and -0.10 ± 0.12, respectively; the corresponding values for logMAR uncorrected distance visual acuity were -0.15 ± 0.11, -0.12 ± 0.12, -0.12 ± 0.13, -0.15 ± 0.12, and 0.01 ± 0.21, respectively. The percentages within ±1.0 diopter (D) of the attempted correction were 96%, 93%, 97%, 99%, and 84% after LASIK, surface ablation, ReLEx, posterior chamber phakic IOL, and iris-supported phakic IOL implantation, respectively. Refractive change from 1 week to 3 months was -0.08 ± 0.07, 0.21 ± 0.63, -0.04 ± 0.41, 0.01 ± 0.31, and 0.01 ± 0.46 D, respectively. No vision-threatening complications occurred during the observation period. CONCLUSIONS: Although more prolonged follow-up is still necessary, currently used refractive surgery procedures have good safety and efficacy outcomes, yielding predictable and stable results. Contemporary LASIK, surface ablation, ReLEx, and phakic IOL implantation appear to be feasible options for the treatment of refractive errors.

Assessment of subjective intraocular forward scattering and quality of vision after posterior chamber phakic intraocular lens with a central hole (Hole ICL) implantation.

PURPOSE: To evaluate the subjective intraocular forward scattering and quality of vision after posterior chamber phakic intraocular lens with a central hole (Hole ICL, STAAR Surgical) implantation. METHODS: We prospectively examined 29 eyes of 29 consecutive patients (15 men and 14 women; ages, 37.2 ± 8.8 years) undergoing Hole ICL implantation. We assessed the values of the logarithmic straylight value [log (s)] using a straylight meter (C-Quant™ , Oculus) preoperatively and 3 months postoperatively. The patients completed a questionnaire detailing symptoms on a quantitative grading scale (National Eye Institute Refractive Error Quality of Life Instrument-42; NEI RQL-42) 3 months postoperatively. We compared the preoperative and postoperative values of the log(s) and evaluated the correlation of these values with patient subjective symptoms. RESULTS: The mean log(s) was not significantly changed, from 1.07 ± 0.20 preoperatively, to 1.06 ± 0.17 postoperatively (Wilcoxon signed-rank test, p = 0.641). There was a significant correlation between the preoperative and postoperative log(s) (Spearman's correlation coefficient r = 0.695, p < 0.001). The postoperative log(s) was significantly associated with the scores of glare in the questionnaire (Spearman's correlation coefficient r = -0.575, p = 0.017). CONCLUSIONS: According to our experience, Hole ICL implantation does not induce a significant additional change in the subjective intraocular forward scattering. The symptom of glare after Hole ICL implantation was significantly correlated with the postoperative intraocular forward scattering in relation to the preoperative one.

Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism: Consort-Compliant Article.

UNLABELLED: The study shows a promising next-generation surgical option for the correction of moderate to high ametropia. Hole implantable collamer lens (ICL), STAAR Surgical, is a posterior chamber phakic intraocular lens with a central artificial hole. As yet, however, no long-term comparison of the clinical results of the implantation of ICLs with and without such a hole has hitherto been conducted. A prospective, randomized, controlled trial was carried out in order to compare the long-term clinical outcomes of the implantation, in such eyes, of ICLs with and without a central artificial hole.Examinations were conducted of the 64 eyes of 32 consecutive patients with spherical equivalents of -7.53 ±â€Š2.39 diopters (D) (mean ±â€Šstandard deviation) in whom implantation of a Hole ICL was performed in 1 eye, and that of a conventional ICL was carried out in the other, by randomized assignment. Before 1, 3, and 6 months, and 1, 3, and 5 years after surgery, the safety, efficacy, predictability, stability, intraocular pressure, endothelial cell density, and adverse events of the 2 surgical techniques were assessed and compared over time.The measurements of LogMAR uncorrected and corrected distance visual acuity 5 years postoperatively were -0.17 ±â€Š0.14 and -0.24 ±â€Š0.08 in the Hole ICL group, and -0.16 ±â€Š0.10 and -0.25 ±â€Š0.08 in the conventional ICL group. In these 2 groups, 96% and 100% of eyes, respectively, were within 1.0 D of the targeted correction 5 years postoperatively. Manifest refraction changed by -0.17 ±â€Š0.41 D and -0.10 ±â€Š0.26 D occurred in from 1 month to 5 years in the Hole and conventional ICL groups, respectively. Only 1 eye (3.1%), which was in the conventional ICL group, developed an asymptomatic anterior subcapsular cataract.Both Hole and conventional ICLs corrected of ametropia successfully throughout the 5-year observation period. It appears likely that the presence of the central hole does not significantly affect these visual and refractive outcomes. TRIAL REGISTRATION: UMIN000018771.

Visual and refractive outcomes of small incision lenticule extraction for the correction of myopia: 1-year follow-up.

OBJECTIVE: To assess the 1 year clinical outcomes of small incision lenticule extraction (SMILE) for the correction of myopia and myopic astigmatism using a 500 kHz femtosecond laser system. METHODS: This prospective study evaluated 52 eyes of 39 consecutive patients (31.8±6.9 years, mean age±SD) with spherical equivalents of -4.11±1.73 D (range, -1.25 to -8.25 D) who underwent SMILE for myopia and myopic astigmatism. Preoperatively, 1 week, and 1, 3, 6 and 12 months postoperatively, we assessed the safety, efficacy, predictability, stability, corneal endothelial cell loss and the adverse events of the surgery. RESULTS: The logarithm of the minimal angle of resolution (logMAR) uncorrected distance visual acuity and LogMAR corrected distance visual acuity were -0.16±0.11 and -0.22±0.07, respectively, 1 year postoperatively. At 1 year, all eyes were within±0.5 D of the targeted correction. Manifest refraction changes of -0.05±0.32 D occurred from 1 week to 1 year postoperatively (p=0.20, Wilcoxon signed-rank test). The endothelial cell density was not significantly changed from 2804±267 cells/mm(2) preoperatively to 2743±308 cells/mm(2) 1 year postoperatively (p=0.12). No vision-threatening complications occurred during the observation period. CONCLUSIONS: SMILE performed well in the correction of myopia and myopic astigmatism, and no significant change in endothelial cell density or any other serious complications occurred throughout the 1-year follow-up period, suggesting its viability as a surgical option for the treatment of such eyes.

Central islands: rate and effect on visual recovery after phototherapeutic keratectomy.

PURPOSE: To retrospectively assess the proportion of patients affected by a central island (CI) and its effect on visual recovery after phototherapeutic keratectomy (PTK). METHODS: This retrospective study evaluated 30 eyes of 21 consecutive patients (mean age ± standard deviation, 69.6 ± 6.8 years) undergoing PTK for the treatment of band keratopathy or granular corneal dystrophy. We investigated the rate of CI formation, which was defined as a steepening area of 3 D, 1.5 mm in diameter, on each corneal videokeratograph (ATLAS 9000; Carl Zeiss Meditec), and its effect on visual recovery at 3 months and at 1 year postoperatively. RESULTS: A CI was found in 22 of 30 eyes (73%) 3 months postoperatively and in 14 of 25 eyes (56%) 1 year postoperatively. The degree of CI was significantly correlated with the change in logMAR corrected visual acuity (Spearman correlation coefficient r = 0.445, P = 0.026). The degree of CI in eyes with band keratopathy was significantly larger than that in eyes with granular dystrophy 1 year postoperatively (Mann-Whitney test, P = 0.045). The degree of CI was not significantly correlated with the ablation depth (Spearman correlation coefficient r = 0.116, P = 0.582) or the residual corneal thickness (r = -0.235, P = 0.278). CONCLUSIONS: CI formation was found in as many as 73 and 56% of patients 3 months and 1 year after PTK, respectively, using the VISX Star S4 excimer laser system, and significantly affected the improvement of visual acuity. The anti-CI program should be applied by the manufacturer, not only for corneal refractive surgery but also for PTK in a clinical setting.