Clinical Evaluation of a Modified Light Transmission Short-Wavelength Filtering Intraocular Lens Compared to a Colorless Control.

INTRODUCTION: The aim of this study was to evaluate the safety and efficacy of a violet-light filtering intraocular lens (IOL) compared to a colorless IOL control. METHODS: This was a prospective, bilateral, randomized, comparative, patient/evaluator-masked multi-center clinical trial at 12 sites in the USA. Patients underwent standard small-incision phacoemulsification cataract extraction. Visual acuity, contrast sensitivity, and color vision were tested 12 months postoperatively. Patient satisfaction and vision-related quality of life were evaluated based on directed patient responses obtained from a binocular subjective questionnaire. RESULTS: A total of 250 subjects were bilaterally implanted with the violet-light filtering TECNIS monofocal ZV9003 (n = 126) and colorless TECNIS monofocal ZA9003 (n = 124). Mean uncorrected distance visual acuity (UDVA) was 0.123 LogMAR for ZV9003 and 0.116 LogMAR for the ZA9003 group. Mean corrected distance visual acuity (CDVA) was 0.00 LogMAR for both groups. No significant difference was found between the groups for 22/25 questionnaire categories, including color perception. A significant difference was found in favor of the ZV9003 group for day driving, night driving, and frustration with vision. Contrast sensitivity mean difference was < 0.05 log units across all lighting conditions and spatial frequencies. CONCLUSION: No difference was found between groups for visual acuity, contrast sensitivity, color testing, and adverse events as well as with the majority of optical/visual symptoms. A statistical difference was noted in driving and frustration with eyesight that may be related to benefits of using a violet-light filtering chromophore. Overall, the violet-light filtering ZV9003 showed excellent visual acuity and contrast sensitivity results with a low incidence of optical/visual symptoms.

PRESBYOND Laser Blended Vision LASIK in Commercial and Military Pilots Requiring Class 1 Medical Certification.

PURPOSE: To report the outcomes of PRESBYOND Laser Blended Vision LASIK (Carl Zeiss Meditec AG) in presbyopic commercial and military pilots requiring Class 1 aeromedical certification. METHODS: This was a retrospective study of 23 consecutive pilots who underwent PRESBYOND Laser Blended Vision LASIK. Postoperative visits were conducted at 1 day and 1, 3, and 12 months. Standard outcomes analysis was performed using the data at 12 months. Objective quality of vision measures including mesopic contrast sensitivity (CSV-1000; VectorVision), Ocular Scatter Index (HD Analyzer; Keeler), and straylight (C-Quant; Oculus Optikgeräte GmbH) were determined before and 3 months after surgery. A questionnaire to assess the functional vision of pilots before and after surgery was derived to record subjective outcomes. RESULTS: Of the 23 pilots treated, data were available at 12 months for 22 pilots (95.7%) and at 3 months for 1 pilot (4.3%). Median age was 55 years (range: 42 to 65 years). At 12 months, binocular uncorrected distance visual acuity was 20/20 or better in 100% and 20/16 or better in 52% of pilots. Binocular uncorrected intermediate visual acuity was J3 in 73%, J5 in 95%, and J10 in 100% of pilots. Binocular uncorrected near visual acuity was J1 or better in 78% and J2 or better in 100% of pilots. Mean postoperative spherical equivalent refraction relative to the target was -0.04 ± 0.34 diopters (D) (range: -0.63 to +0.63 D), with 93% within ±0.50 D. There was a statistically significant increase in contrast sensitivity at 3, 6, 12, and 18 cpd. C-Quant straylight was 1.07 ± 0.16 before surgery and 1.06 ± 0.16 at 1 to 3 months after surgery (P = .705). All pilots achieved Class 1 medical certification from the United Kingdom Civil Aviation Authority and resumed flying. All pilots reported improved functionality compared to the previous vision correction method. CONCLUSIONS: PRESBYOND Laser Blended Vision LASIK enabled presbyopic commercial pilots to continue to fly without the need for glasses. With consideration of the visually challenging cockpit environment, PRESBYOND Laser Blended Vision LASIK provides clear continuous vision for tasks at near, intermediate, and far distance. Class 1 pilots reported a subjective improvement in visual tasks and comfort following surgery. [J Refract Surg. 2023;39(1):6-14.].

Changes in Light Disturbance Analyzer Evaluation in SMILE for High Myopia and Astigmatism.

PURPOSE: To study the objective change in light disturbance around a glare source using the Light Disturbance Analyzer (LDA) (Binarytarget Lda) and correlate this with the validated subjective quality of vision (QoV) questionnaire in small incision lenticule extraction (SMILE) for high compound myopic astigmatism. METHODS: This was a prospective study recruiting 114 patients undergoing SMILE with attempted spherical equivalent refraction (SEQ) correction from -9.00 to -13.00 diopters (D), and cylinder up to 5.00 D. The LDA was used before and 3 and 12 months after surgery to evaluate the Light Disturbance Area, Light Disturbance Index, Best Fit Circle Radius, and Best Fit Circle Irregularity. Patients completed the Rasch-validated QoV questionnaire before and 12 months after surgery. Correlation analysis was performed between the LDA parameters and the QoV frequency, severity, and bothersomeness for halos and starbursts. RESULTS: At 12 months, there was a non-statistically signifcant change of 11.9% for Light Disturbance Area and Light Disturbance Index and 6.5% for Best Fit Circle Radius. There was an increase of 81.9% for Best Fit Circle Irregularity (P = .017). Light Disturbance Area, Light Disturbance Index, and Best Fit Circle Radius correlated with bothersomeness for QoV halos, and with frequency, severity and bothersomeness for QoV star-bursts (P < .05), albeit with a low correlation coefficient (R2 < 0.13). There was no correlation between increase in Best Fit Circle Irregularity and the halo and starburst scores from the QoV questionnaire. CONCLUSIONS: LDA Best Fit Circle Irregularity was found to increase following high myopic SMILE. Other LDA parameters appeared to increase, but a much larger sample would be required to find statistical significance. The change in LDA parameters was only weakly correlated with QoV halo and starburst metrics, representing the wide variation in inter-subject perception. [J Refract Surg. 2022;38(11):725-732.].

Large Population Outcomes of Small Incision Lenticule Extraction in Young Myopic Patients.

PURPOSE: To evaluate the outcomes of small incision lenticule extraction (SMILE) for myopia in a large population of young adults. METHODS: In this retrospective case series, the patient population consisted of the first 4,138 consecutive SMILE treatments using the VisuMax femtosecond laser (Carl Zeiss Meditec) between 2012 and 2018 at the London Vision Clinic. Inclusion criteria were myopic spherical equivalent up to -9.00 diopters (D), cylinder up to 6.00 D, corrected distance visual acuity of 20/20 or better, age younger than 40 years, and follow-up of 12 months. Outcomes analysis was performed using the Standard Graphs for Reporting Refractive Surgery. RESULTS: Data were available at 12 months in 3,722 eyes (90%), and 416 eyes (10%) were lost to follow-up. Mean attempted spherical equivalent refraction (SEQ) was -4.61 ± 1.84 D (range: -1.12 to -9.00 D). Mean cylinder was -0.78 ± 0.66 D (range: 0.00 to -6.00 D). Postoperatively, the mean SEQ relative to target was -0.13 ± 0.30 D (range: -1.35 to +1.25 D) and was within ±0.50 D in 88.1% and ±1.00 D in 99.6% of eyes. Uncorrected distance visual acuity was 20/20 or better in 95.4% of eyes and 20/25 or better in 98.7% of eyes. One line of CDVA was lost in 3.0% of eyes, and 0.08% (n = 3) lost two or more lines of CDVA, for which CDVA was restored following phototherapeutic keratectomy treatment. There was a statistically significant improvement of 0.05, 0.06, 0.07, and 0.07 log units for contrast sensitivity at 3, 6, 12, and 18 cycles per degree, respectively (P < .001). CONCLUSIONS: SMILE achieved excellent outcomes for myopia up to -9.00 D with cylinder up to -5.50 D for a large population in patients without presbyopia. [J Refract Surg. 2022;38(8):488-496.].

Applications of epithelial thickness mapping in corneal refractive surgery.

In this review, we discuss the applications of epithelial thickness mapping in corneal refractive surgery. The review describes that the epithelial thickness profile is nonuniform in the normal eye, being thinner superiorly than inferiorly and thinner temporally than nasally. It is postulated that this is due to the eyelid forces and blinking action on the superior cornea. Changes in the epithelial thickness profile have been found to be highly predictable, responding to compensate for changes in the stromal curvature gradient, using the eyelid as an outer template. This leads to characteristic changes in the epithelial thickness profile that can be used for early screening in keratoconus, postoperative monitoring for early signs of corneal ectasia, and for determining whether further steepening can be performed without the risk of apical syndrome following primary hyperopic treatment. Compensatory epithelial thickness changes are also a critical part of diagnosis in irregular astigmatism as these partially mask the stromal surface irregularities. The epithelial thickness map can then be used to plan a trans-epithelial photorefractive keratectomy treatment for cases of irregularly irregular astigmatism.

Epithelial thickness mapping for corneal refractive surgery.

PURPOSE OF REVIEW: As more devices become available that offer corneal epithelial thickness mapping, this is becoming more widely used for numerous applications in corneal refractive surgery. RECENT FINDINGS: The epithelial thickness profile is nonuniform in the normal eye, being thinner superiorly than inferiorly and thinner temporally than nasally. Changes in the epithelial thickness profile are highly predictable, responding to compensate for changes in the stromal curvature gradient, using the eyelid as an outer template. This leads to characteristic changes that can be used for early screening in keratoconus, postoperative monitoring for early signs of corneal ectasia, and for determining whether further steepening can be performed without the risk of apical syndrome following primary hyperopic treatment. Compensatory epithelial thickness changes are also a critical part of diagnosis in irregular astigmatism as these partially mask the stromal surface irregularities. The epithelial thickness map can then be used to plan a trans-epithelial PRK treatment for cases of irregularly irregular astigmatism. Other factors can also affect the epithelial thickness profile, including dry eye, anterior basement membrane dystrophy and eyelid ptosis. SUMMARY: Epithelial thickness mapping is becoming a crucial tool for refractive surgery, in particular for keratoconus screening, ectasia monitoring, hyperopic treatment planning, and therapeutic diagnosis and treatment.

Objective and Subjective Quality of Vision After SMILE for High Myopia and Astigmatism.

PURPOSE: To report subjective and objective quality of vision (QoV) results for high myopic small incision lenticule extraction (SMILE) between -9.00 and -13.00 diopters (D). METHODS: This was a prospective study recruiting 114 patients undergoing SMILE with attempted spherical equivalent refraction (SEQ) correction from -9.00 to -13.00 D, and cylinder up to 5.00 D. Patients were informed before surgery of the increased risk of QoV symptoms. Patients completed the Rasch validated QoV questionnaire. Objective QoV was assessed by corneal and whole eye aberrations, HD Analyzer Objective Scatter Index (OSI) (Keeler), and contrast sensitivity. Patient satisfaction was assessed on a scale from 0 (very dissatisfied) to 10 (very satisfied). Individual item and total Rasch-scaled scores for the three subscales (frequency, severity, and bothersomeness) of the QoV questionnaire were calculated before and 12 months after surgery. RESULTS: The mean patient satisfaction score was 9.27 ± 1.18 (range: 2 to 10), 8 or higher in 93%, and 7 or higher in 98% of patients. One patient with a satisfaction score of 2 had a simple refractive error re-treatment and then reported a satisfaction score of 10. The total mean ± standard deviation Rasch-scaled QoV score for the frequency, severity, and bothersomeness subscales before surgery was 24 ± 19, 20 ± 16, and 19 ± 18, respectively. Scores increased after surgery to 41 ± 18, 32 ± 16, and 30 ± 21, respectively (P < .001). Corneal aberrations (6 mm, OSI) increased on average by 0.39 µm for spherical aberration, 0.41 µm for coma, and 0.56 µm for higher order aberrations root mean square. OSI increased on average by 0.58. There was a small but statistically significant improvement in contrast sensitivity at 3, 6, 12, and 18 cycles per degree. There were no statistically significant correlations found between subjective scores for starbursts and objective measurements. CONCLUSIONS: Satisfaction was high following SMILE for high myopia. As expected, there was an increase in QoV symptoms, mainly glare and starbursts. The acceptance of QoV symptoms for high myopic SMILE was high, indicating that residual refractive error and visual acuity are the major drivers for patient satisfaction with appropriate preoperative informed consent. [J Refract Surg. 2022;38(7):404-413.].

Comparison of Epithelial Thickness Mapping in Normal Corneas with Different Types of Astigmatism.

SIGNIFICANCE: Corneal epithelial thickness mapping has a wide range of applications including screening for keratoconus, screening for anterior basement membrane dystrophy, and assessment of dry eye. It also plays an important role in corneal laser refractive surgery. These all require an understanding of the epithelial thickness profile in a normal cornea as a reference. PURPOSE: This study aimed to compare corneal epithelial thickness along different meridians in normal eyes with different types of corneal astigmatism. METHODS: In this cross-sectional study, corneal topography and epithelial thickness mapping by anterior segment optical coherence tomography was performed for 154 normal eyes. Corneal astigmatism was classified based on the orientation of the steepest corneal meridian (with-the-rule [WTR], against-the-rule [ATR], and oblique) and the amount (low, moderate, and high). On a 9-mm epithelial thickness map, the thickness along the horizontal (180°), vertical (90°), and diagonal (45 and 135°) meridians was calculated. RESULT: With-the-rule, oblique, and ATR astigmatisms were observed in 40, 31, and 29% of the eyes, respectively. In all types of astigmatism, the mean epithelial thickness was greater along the 180° meridian and thinner along the 90° meridian. There was no statistically significant difference in mean thickness along different meridians for WTR (P = .24) and oblique (P = .46) astigmatism, whereas the difference along the 180 and 90° meridians (P = .003) for ATR astigmatism was statistically significant. Also, there was a statistically significant difference in thickness in different types of astigmatism separately for each meridian (P < .05) so that the highest and lowest thicknesses were seen for ATR and oblique astigmatisms, respectively. The epithelial thickness showed no statistical difference in various amounts of astigmatism along different meridians. CONCLUSIONS: Thicker epithelium along the horizontal meridian in ATR may point to the surface regularizing functions of the epithelium to create a regular and smooth surface, but thickness assessment along the different meridians in oblique and WTR showed no curvature-dependent changes.

New Sizing Parameters and Model for Predicting Postoperative Vault for the Implantable Collamer Lens Posterior Chamber Phakic Intraocular Lens.

PURPOSE: To identify parameters influencing the postoperative vault of the Implantable Collamer Lens (ICL) (STAAR Surgical) using the Artemis Insight 100 very high-frequency (VHF) digital ultrasound robotic scanner (ArcScan, Inc) and develop a model to improve lens vault prediction. METHODS: This was a retrospective analysis of 147 consecutive V4c EVO and EVO+ ICL implantation procedures performed over three phases in myopic eyes. In the initial phase, lens size was defined by published sulcus-to-sulcus and crystalline lens rise measurements (Kojima formula) from VHF digital ultrasound biometry. From these data, a stepwise multivariate regression analysis was performed to develop a model for predicting central vault including the following variables: ICL size, ICL power, sulcus-to-sulcus (STS), ciliary body inner diameter (CBID), zonule-to-zonule, STS lens rise (STSL), ACD, anterior chamber angle, scotopic pupil diameter (SPD), angle-to-angle, and white-to-white diameter. The resulting regression model was used in coordination with the Kojima formula to select the lens size for the next series of eyes. The regression analysis was then repeated and a further series were treated. The postoperative achieved vault at 1 month was compared to the target vault predicted by the formula. A comparison analysis of the new model was made to previously published lens sizing formulas. RESULTS: Statistically significant variables were ICL size, ICL power, CBID, STSL, and SPD. The primary 42 eyes (Kojima formula) achieved a mean vault of 506 ± 233 µm, a range of 810 µm (114 to 924 µm), and an interquartile range (IQR) of 391 µm. Using the Reinstein formula v1.0 for the next 36 eyes, the mean vault relative to target was +7 ± 123 µm, range of 569 µm (-278 to +291 µm), and IQR of 169 µm. Using the Reinstein formula v2.0 for the next 69 eyes, the mean vault relative to target was +67 ± 121 µm, range of 573 µm (-219 to +354 µm), and IQR of 131 µm. The achieved vault was within ±100, ±200, and ±300 µm of target in 33%, 50%, and 74% of eyes, respectively, for the training group, 58%, 89%, and 100% for the Reinstein formula v1.0 group, and 62%, 84%, and 94% for the Reinstein formula v2.0 group. CONCLUSIONS: This is the first report describing the ciliary body inner diameter, which proved to be more highly correlated with vault than STS, and thus CIBD supersedes STS from the previous widely accepted improvement over WTW sizing. The new model also found scotopic pupil size to be a significant predictor, which has not been a part of any previously published model. The significant improvement in vault predictability afforded by these parameters and the new model enables charting attempted versus achieved vault outcomes for the first time. [J Refract Surg. 2022;38(5):272-279.].

Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia With Astigmatism.

PURPOSE: To report the outcomes of small incision lenticule extraction (SMILE) for high myopia between -9.00 and -14.00 diopters (D). METHODS: This was a prospective study of SMILE for high myopia using the VisuMax femtosecond laser (Carl Zeiss Meditec). Inclusion criteria were attempted spherical equivalent refraction (SEQ) between -9.00 and -14.00 D, cylinder up to 7.00 D, corrected distance visual acuity (CDVA) of 20/40 or better, age 21 years or older, and suitable for SMILE. The sub-lenticule thickness was 220 µm or greater, and the total uncut stromal thickness was 300 µm or greater. Patients were to be followed up for 1 year. Standard outcomes analysis was performed using 12-month data where available or 3-month data otherwise. RESULTS: Of 187 eyes treated, data were available at 12 months for 181 eyes (96.8%) and 3 months for 4 eyes (2.1%), and 2 eyes (1.1%) were lost to follow-up. Mean attempted SEQ was -10.55 ± 1.00 D (range: -9.00 to -12.99 D). Mean cylinder was -1.19 ± 0.83 D (range: 0.00 to -4.00 D). Preoperative CDVA was 20/20 or better in 73% of eyes. Postoperative uncorrected distance visual acuity was 20/20 or better in 57% and 20/25 or better in 82% of eyes. Mean SEQ relative to target was -0.22 ± 0.48 D (range: -1.63 to +1.38 D), 66% ± 0.50 D and 93% ±1.00 D. Mean SEQ 12-month change was -0.08 ± 0.34 D (range: -1.75 to +0.88 D). There was loss of one line of CDVA in 4% of eyes, and no eyes lost two or more lines. Contrast sensitivity was unchanged. Patient satisfaction was 8 or more out of 10 in 94% and 6 or more in 99% of patients. CONCLUSIONS: Outcomes of SMILE for myopia greater than -9.00 D at 3 to 12 months showed excellent efficacy, safety, stability, and predictability, with high patient satisfaction. [J Refract Surg. 2022;38(5):262-271.].

Visual Outcomes, Footplate Position and Vault Achieved with the Visian Implantable Collamer Lens for Myopic Astigmatism.

PURPOSE: Report the outcomes of the implantable collamer lens (ICL) in myopic astigmatism using very high-frequency (VHF) digital ultrasound sizing. METHODS: Analysis of 42 consecutive ICL procedures using EVO and EVO+ (Visian V4c) lenses (STAAR Surgical) was done. ICL size was chosen using the ultrasound-based Kojima Formula with Insight 100 VHF digital ultrasound (VHFDU). Standard visual outcomes analysis was performed using 3-month data, also including contrast sensitivity, refractive and corneal vector analysis, and ECC. Postoperative lens position was evaluated using VHF digital ultrasound. RESULTS: Attempted SEQ was -10.83±3.39D (-4.40 to -16.98D). Cylinder was -1.46±1.15D (0.00 to -4.25D). One-year follow-up was available in 86% of the eyes and 3 months in 96%. Postoperative UDVA was 20/20 or better in 89% of the eyes, relative to 71% preoperatively. Postoperative SEQ refraction was ±0.50 D in 74% and ±1.00 D in 98% of the eyes. There was a gain of one line of CDVA in 43% of the eyes, 2 or more lines in 10% of the eyes, while there was a one line loss in 7% and no eyes lost 2 or more lines. The vector mean for the corneal SIA was 0.24 D Ax 100. Contrast sensitivity showed a statistically significant increase with a mean of 0.14 log units at 6, 12, and 18 cycles per degree (P<0.01). The mean change in ECC was -153±353 cells/mm2. Lens vault was 506±233 µm (114-924 µm). Footplate insertion was in zonular position in 48.3%, ciliary body in 49.2%, and sulcus in 2.5% of locations. CONCLUSION: ICL implantation resulted in high safety and efficacy but with an implantation vault range that ideally would be improved upon. VHF digital ultrasound of the lens footplate and posterior anatomical relations may provide essential information for evaluating postoperative vault outliers.

Cap recovery technique and double-edge sign during small-incision lenticule extraction.

PURPOSE: To describe a new technique for identifying the upper (cap) interface during small-incision lenticule extraction (SMILE). If the lower interface is dissected first it can be challenging to locate the cap interface and complete the lenticule separation. SETTING: London Vision Clinic, London, United Kingdom. DESIGN: Retrospective analysis. METHODS: The routine protocol was to open the primary small incision and separate the cap interface, followed by the lenticule interface. If the lenticule interface was dissected first, the modified Sinskey tip was inserted through the superior end of the incision, tangentially along the cap edge interface and then rotated anteriorly to engage the edge of the lenticule adherent to the underside of the cap. The Sinskey tip is then drawn inferiorly, creating a pocket of separation of the lenticule from the cap, enabling the dissection bulb and spatula to be used to dissect the upper interface. RESULTS: A total of 629 consecutive eyes undergoing SMILE using the VisuMax femtosecond laser were included. The routine surgical protocol (cap interface first) was followed in 88% of eyes and the lenticule interface first in 12% of eyes. The lenticule was extracted successfully in all cases. Uncorrected distance visual acuity at the 1-day postoperative visit was 20/25 or better in 81% of the cap interface first group and 86% of the lenticule interface first group. CONCLUSIONS: The visual results using this cap recovery technique were equivalent to those when a routine SMILE dissection was performed. The technique allowed surgeons to rescue more challenging cases where identifying the different interfaces was difficult. This technique meant that separating the lenticule interface first should no longer be considered a complication of SMILE.

Postoperative Corneal Epithelial Remodeling After Intracorneal Ring Segment Procedures for Keratoconus: An Optical Coherence Tomography Study.

PURPOSE: To assess epithelial corneal remodeling by anterior segment optical coherence tomography (AS-OCT) after intracorneal ring segments (ICRS) implantation in keratoconic eyes. METHODS: This prospective observational study included patients with keratoconus receiving ICRS of different arc lengths according to their tomographic pattern. AS-OCT and corneal topography (Scheimpflug camera) were performed before and 1, 3, and 6 months after surgery. Corneal pachymetry mapping was performed and total corneal and epithelial thicknesses (3-mm central and 16 points on 6-mm zone) were measured over the pupil center using AS-OCT. Topographic parameters were also assessed. RESULTS: A total of 68 keratoconic eyes were analyzed (Amsler-Krumeich stages 1 to 4) in four groups of 17 eyes: 210° ICRS, 320° ICRS, double 160° ICRS, and single 160° ICRS. Corneal pachymetry mapping revealed that epithelial thickness increased significantly in the internal zones juxtaposed to the ICRS without smoothing during the postoperative period (P < .05). Mean maximum epithelial thickness increased from 67 ± 6 to 79 ± 7 µm for 210° ICRS, 66 ± 9 to 82 ± 4 µm for 320° ICRS, 63 ± 6 to 78 ± 7 µm for double 160° ICRS, and 62 ± 5 to 77 ± 5 µm for single 160° ICRS (P < .0001). Significant epithelial thickening at the apex of the cone was observed in all groups (P < .05). CONCLUSIONS: Significant epithelial thickening occurs after ICRS implantation adjacent to the ICRS to compensate for the ridge created with a thickening of epithelium over the cone due to regularization of the stromal surface. [J Refract Surg. 2021;37(6):404-413.].

Distribution of Pupil Offset and Angle Kappa in a Refractive Surgery Preoperative Population of 750 Myopic, Emmetropic, and Hyperopic Eyes.

PURPOSE: To report the distribution of pupil offset and angle kappa in 750 myopic, emmetropic, and hyperopic eyes presenting for refractive surgery. METHODS: A retrospective study included 750 consecutive eyes screened for corneal refractive surgery between January 2006 and February 2013. The eyes were divided into three equal groups based on manifest refraction spherical equivalent (SEQ): emmetropic group between -0.25 and +0.50 diopters (D) and cylinder up to 1.00 D, myopic group greater than -0.50 D, and hyperopic group greater than +0.50 D. Angle kappa was measured with the Orbscan II software (Bausch & Lomb, Inc) and pupil offset defined as the distance at the corneal plane between the corneal vertex and the pupil center. Correlations with SEQ, cylinder, scotopic pupil diameter, average keratometry, and age were performed. RESULTS: All results are reported for myopic, emmetropic, and hyperopic groups, respectively. Mean SEQ was -4.84 ± 2.89 D (range: -0.88 to -14.00 D), +0.21 ± 0.23 D (range: -0.25 to +0.50 D), and +2.44 ± 1.58 D (range: +0.63 to +7.75 D). Mean pupil offset magnitude was 0.27 ± 0.14 mm (range: 0.00 to 0.68 mm), 0.34 ± 0.14 mm (range: 0.02 to 0.78 mm), and 0.39 ± 0.13 mm (range: 0.07 to 0.75 mm). Mean pupil offset X-component was -0.18 ± 0.18, -0.28 ± 0.16, and -0.34 ± 0.15 mm (temporally displaced from the corneal vertex). Mean pupil offset Y-component was 0.06 ± 0.15, 0.03 ± 0.16, and 0.01 ± 0.16 mm (superiorly displaced from the corneal vertex). Multivariate linear regression for pupil offset magnitude found statistically significant variables were SEQ, cylinder, scotopic pupil diameter, and average keratometry. For pupil offset X-component, significant variables were SEQ, cylinder, and scotopic pupil diameter. For pupil offset Y-component, significant variables were SEQ and scotopic pupil diameter. Mean angle kappa was 5.28 ± 1.49°, 6.14 ± 1.44°, and 5.77 ± 1.29°. CONCLUSIONS: Contrary to common belief, a pupil offset is present in the vast majority of eyes regardless of refractive error, with the mean temporal offset of at least 0.18 mm. Confirming previous studies, the largest pupil offset was found in the hyperopic group. However, there was also a wide range of pupil offset in myopic and emmetropic eyes. Correlations with SEQ and keratometry support the theory that pupil offset is also correlated with axial length. [J Refract Surg. 2021;37(1):49-58.].

Correction of Moderate to High Hyperopia With Implantation of an Allogeneic Refractive Lenticule.

PURPOSE: To describe the visual outcomes of correcting moderate to high hyperopia after two different surgical procedures of lenticular implantation. METHODS: This prospective small case series study used epikeratophakia combined with transepithelial phototherapeutic keratectomy (PTK-EP) and femtosecond laser-assisted lenticule intrastromal keratoplasty (LIKE) using myopic small incision lenticule extraction (SMILE)-derived refractive lenticule for correcting hyperopia ranging from +3.00 to +10.00 diopters (D). The implanted refractive lenticule was matched with the recipient's manifest refraction. The visual, refractive, corneal tomographic, and epithelial thickness outcomes were analyzed after surgery. RESULTS: Four eyes underwent PTK-EP and 6 eyes underwent LIKE. At the last postoperative visit, 6 of 10 eyes had uncorrected distance visual acuity equal to or better than the preoperative corrected distance visual acuity (CDVA). No eyes lost one line or more of CDVA postoperatively. Postoperative spherical equivalent was within ±0.50 D of the target for 9 of 10 eyes. Posterior corneal curvature slightly steepened for PTK-EP and LIKE. Postoperative epithelial thickness demonstrated the expected doughnut pattern in both groups characterized by epithelium in the central zone (5 mm) thinner than that in the peripheral zone (5 to 7 mm). CONCLUSIONS: Visual outcomes, refraction, posterior corneal surface changes, and epithelial remodeling after PTKEP or LIKE show a potentially useful modality for correcting moderate to high hyperopia. [J Refract Surg. 2020;36(11):772-779.].

Epithelial implantation treatment after small-incision lenticule extraction.

Two cases of epithelial implantation after small-incision lenticule extraction (SMILE) treated by Nd:YAG laser and interface sweeping are described. A 40-year-old woman and 33-year-old man underwent SMILE and subsequently were noted to have epithelial cells implanted into the surgical interface. One case was treated using Nd:YAG laser. The laser was focused to the level of the interface with an energy level of 0.3 mJ. The treatment covered the entire area of epithelial implantation. The second case was treated by opening the original SMILE incision and sweeping the residual epithelial cells from the interface followed by a washout. Both the Nd:YAG laser and interface sweeping proved to be effective in reducing or eliminating the epithelial cells from the SMILE interface. Further studies are needed to report on overall safety and efficacy of these 2 techniques.

Suction stability management in small incision lenticule extraction: incidence and outcomes of suction loss in 4000 consecutive procedures.

PURPOSE: To report the incidence and outcomes of suction loss during small incision lenticule extraction (SMILE). METHODS: The incidence of suction loss was measured over 4000 consecutive SMILE procedures and categorized by cause, the interface in which suction was lost and management (restart/continue SMILE, re-SMILE thinner cap, convert to laser in-situ keratomileusis [LASIK]). One-year outcomes were compared to the fellow eye where no suction loss occurred. RESULTS: There were 20 cases of suction loss (0.50%): during the lenticule interface in seven eyes, lenticule side cut in one eye, cap interface in nine eyes and small incision for three eyes. Small incision lenticule extraction (SMILE) was continued in seven eyes, thinner cap SMILE in four eyes, LASIK in eight eyes, and the small incision was manually completed in one eye. Suction loss was caused by a Bell's reflex in 10 eyes, fixation light tracking in six eyes, patient anxiety in two eyes, a nociceptive reflex in one eye and false suction in one eye. There was no difference in results for suction loss and fellow eyes, respectively: uncorrected distance visual acuity was 20/20 or better in 100% in both groups, spherical equivalent was within ±0.50 D in 85% and 79%, one line loss of corrected distance visual acuity in 5% and 0%, and no eyes lost two lines. CONCLUSION: Suction loss can be managed depending on the interface during which suction is lost. Treatment was completed on the same day in all instances. Visual and refractive outcomes were unaffected compared to the fellow eye in this series.

Femtosecond Laser-Assisted Small Incision Sutureless Intrastromal Lamellar Keratoplasty (SILK) for Corneal Transplantation in Keratoconus.

PURPOSE: To describe a femtosecond laser-assisted small incision sutureless intrastromal lamellar keratoplasty in an eye with severe keratoconus and report on the outcome with a 1-year follow-up. METHODS: A 20-year-old man with a history of keratoconus presented for evaluation at the Tilganga Institute of Ophthalmology, Kathmandu, Nepal. The patient had previously undergone a deep anterior lamellar keratoplasty in the left eye. Examination of the right eye revealed an uncorrected distance visual acuity (UDVA) of counting fingers with a manifest refraction of -5.00 -3.50 × 170, giving a corrected distance visual acuity (CDVA) of 20/80. Thinnest pachymetry was 425 µm and progression of both anterior and posterior corneal elevation tomography and maximum keratometry was noted compared to examination 2 years prior. The VisuMax femtosecond laser (Carl Zeiss Meditec, Jena, Germany) was used to prepare the donor and recipient cornea. The donor graft was inserted into the recipient through the 3-mm small incision. No sutures were applied. RESULTS: At 2 weeks postoperatively, UDVA was 20/50 with a manifest refraction of -1.00 -5.00 × 145 (20/32). One year postoperatively, UDVA was 20/80 with a manifest refraction of -2.50 -3.50 × 125 (20/40-2), with the maximum keratometry decreasing from 64.08 to 56.74 diopters. CONCLUSIONS: This femtosecond laser-assisted sutureless intrastromal corneal transplantation technique may provide an option to improve the quality of vision for some patients with keratoconus, affording a simpler postoperative follow-up course compared to traditional anterior lamellar or full-thickness corneal transplantation. [J Refract Surg. 2019;35(10):663-671.].

Aborted small-incision lenticule extraction resulting from false plane creation and strategy for subsequent removal based on corneal layered pachymetry imaging.

We describe a complication of false plane creation during small-incision lenticule extraction (SMILE) and the surgical plan for subsequent lenticule removal. During a primary SMILE procedure to treat high myopia, the separator instrument entered a false lamellar plane as a result of an area of resistance caused by an area of opaque bubble layer (OBL). The procedure was aborted to avoid removing an irregular lenticule. Based on measurements of the anatomic landscape, a new inferonasal small incision was created. The lenticule was separated and removed without further incidence. The patient recovered as normal and at 6 months, the uncorrected distance visual acuity was 20/16-1. This case highlights the importance of monitoring the bubble layer creation and interface separation to avoid creating or removing an irregular lenticule. It also shows the importance of layered corneal imaging to analyze and diagnose complications as well as of aborting a procedure and planning lenticule removal at a later time if deemed appropriate.

Small-incision lenticule extraction in a patient with high astigmatism and nystagmus.

Small-incision lenticule extraction (SMILE) was performed in a patient with high astigmatism and nystagmus. The patient presented for a refractive surgery evaluation with a manifest refraction of -0.50 -6.00 × 137 (20/40-1) in the right eye and -2.25 -2.25 × 30 (20/40-1) in the left eye. The patient was deemed suitable for corneal laser refractive surgery. Consideration was given to SMILE, laser in situ keratomileusis, and photorefractive keratectomy. It was decided SMILE was the best option given that the refractive portion of the procedure is performed while the cornea is immobilized by suction. The treatment was uneventful, and the final manifest refraction was +0.25 -0.25 × 130 (20/40) in the right eye and +0.25 diopter sphere (20/40) in the left eye. Topography was normal, showing a well-centered treatment zone. This case highlights an additional use for SMILE, given its ability to immobilize the cornea during treatment.