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Refractive Surgery

Refractive Surgery Publications

Huang G, Melki S. Small Incision Lenticule Extraction (SMILE): Myths and Realities. Semin Ophthalmol 2021;:1-9.Abstract
The emergence of SMILE in the last decade has provided an alternative to LASIK for patients considering cornea laser refractive surgery. SMILE offers a novel approach using the femtosecond laser to create an intrastromal lenticule that can be removed through a small three to four millimeter incision.The purpose of this study is to review the recent literature on popular SMILE claims - reduced iatrogenic dry eye, better recovery of corneal sensation, and a biomechanically stronger cornea - summarize the published outcomes, and determine which claims are myths versus realities.SMILE is still in its infancy as a refractive technique in the US after recent USFDA approval for its treatment of myopia astigmatism in October 2018. Future randomized controlled studies are needed to compare its outcomes to LASIK, which has well-documented good visual outcomes, rapid postoperative recovery, and good safety profile.
Ma KK, Yuan A, Sharifi S, Pineda R. A Biomechanical Study of Flanged Intrascleral Haptic Fixation of Three-Piece Intraocular Lenses: Biomechanical study of flanged intrascleral haptic fixation. Am J Ophthalmol 2021;Abstract
PURPOSE: Flanged intrascleral haptic fixation (FISHF) is a useful method to secure intraocular lenses (IOLs) in eyes without capsular support. Biomechanical studies were conducted to support the use of this technique. DESIGN: Laboratory investigation METHODS: Haptics of 3-piece IOLs were passed through cadaveric human sclera using 30-gauge and 27-gauge needles. Flanges were created by melting 1.0 mm from the haptic ends using cautery. The forces required to remove the flanged haptic from the sclera and disinsert the haptic from the optic were measured using a mechanical tester and a custom-fabricated mount. RESULTS: The mean FISHF dislocation force using 30-gauge needles was greatest with the CT Lucia 602 (2.04 ± 0.24 N) compared to the LI61AO (0.93 ± 0.41 N; p=0.001), ZA9003 (0.70 ± 0.34 N; p=<0.001), and MA60AC (0.27 ± 0.19 N; p<0.001). Using 27-gauge needles with the CT Lucia resulted in a lower dislocation force (0.56 ± 0.36 N, p<0.001). The FISHF dislocation force was correlated with the flange-to-needle diameter ratio (r=0.975). The FISHF dislocation forces of the CT Lucia and LI61AO using 30-gauge needles were not significantly different from their haptic-optic disinsertion forces (p=0.79 and 0.27 respectively). There was no difference in flange diameter between 1.0 mm and 2.0 mm haptic melt lengths across the IOLs (p=0.15-0.85). CONCLUSIONS: This data strongly supports the biomechanical stability of FISHF with the polyvinylidene fluoride haptics of the CT Lucia using small diameter instruments for intrascleral tunnel creation. 1.0 mm of haptic may be the optimal melt length.
Ozulken K, Ilhan C, Yuksel E, Mumcuoglu T. Preliminary effects of treating the half of high latent hyperopia on refractive and visual results of femtosecond laser-assisted in situ keratomileusis in subjects with hyperopia. Int Ophthalmol 2020;40(9):2361-2369.Abstract
BACKGROUND: To evaluate the preliminary effects of treating the half of high latent hyperopia on refractive and visual outcomes of femtosecond laser-assisted in situ keratomileusis (LASIK) in young subjects with hyperopia. METHODS: This non-randomized comparative study includes 120 eyes of 60 subjects who underwent femtosecond LASIK to correct hyperopia. Group 1 (n = 60) includes subjects with ≤ 1D algebraic difference (DRSE) between cycloplegic (CRSE) and manifest (MRSE) refraction spherical equivalents and was treated by entering manifest refraction values. Group 2 includes subjects with > 1D DRSE and was treated by entering the mean manifest and cycloplegic refraction values. Refractive and subjective outcomes obtained at the 1-, 3-, and 6-month postoperative visits were compared. RESULTS: The mean age of the subjects was 26.2 ± 3.5 and 26.2 ± 5.2 years for Group 1 and Group 2, respectively. The male-to-female ratios were 10/10 in both groups. Demographic values of the groups were similar (p > 0.05). Preoperative MRSE values were similar (p = 0.924), while CRSE and DRSE values were significantly higher in Group 2 (p < 0.001). At the 1- and 3-month postoperative visits, MRSE was higher and uncorrected distance visual acuity (UDVA) was lower in Group 2 (p < 0.001). Subjective visual parameters and quality of vision scores were also worse in Group 2 during these visits (p < 0.001); however, at the 6-month visit, all outcomes for Group 2 improved, and MRSE, UDVA, some subjective visual parameters, and quality of vision scores became similar between groups (p > 0.05). CONCLUSION: At the 6-month visit after treating the half of > 1D latent hyperopia with femtosecond LASIK, refractive and visual outcomes like MRSE, UDVA, subjective visual parameters, and quality of vision scores become similar to those obtained in ≤ 1D latent hyperopia.
Kaufman AR, Nosé RM, Lu Y, Pineda R. Phacoemulsification with intraocular lens implantation after previous descemetorhexis without endothelial keratoplasty. J Cataract Refract Surg 2017;43(11):1471-1475.Abstract
A 58-year-old woman with bilateral Fuchs endothelial corneal dystrophy presented with predominantly central guttata in the left eye causing visually significant stromal edema. A 4.0 mm descemetorhexis without endothelial keratoplasty was performed. At the 6-week follow-up, the central cornea had cleared completely and the central endothelial cell density (ECD) was 541 cells/mm2. The central corneal clearing remained stable for 2 years after the procedure; however, vision declined because of a visually significant cataract in the left eye. Uneventful phacoemulsification with intraocular lens implantation was performed with a target refraction of -0.50 diopters. At 1.5 months postoperatively, the uncorrected distance visual acuity was 20/20 with a manifest refraction of -0.25 -0.25 × 60 and the central ECD was 2373 cells/mm2 (increased from 1471 cells/mm2 prior to phacoemulsification). Cataract surgery by phacoemulsification years after descemetorhexis without endothelial keratoplasty appears to be well-tolerated, with good clinical and predictive refractive outcomes.
Zhang C, Ding H, He M, Liu L, Liu L, Li G, Niu B, Zhong X. Comparison of Early Changes in Ocular Surface and Inflammatory Mediators between Femtosecond Lenticule Extraction and Small-Incision Lenticule Extraction. PLoS One 2016;11(3):e0149503.Abstract

PURPOSE: To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after femtosecond lenticule extraction (FLEx) and small-incision lenticule extraction (SMILE) procedures. METHODS: Eighteen subjects (18 eyes) underwent FLEx and 23 subjects (23 eyes) underwent SMILE in this single-center and prospective study. Central corneal sensitivity, Schirmer I test (SIT), noninvasive tear breakup time (NI-TBUT), tear meniscus height, corneal fluorescein (FL) staining, and ocular surface disease index (OSDI) were assessed in all patients. Concentrations of interleukin-1α (IL-1α), tumor necrosis factor-α (TNF-α), nerve growth factor (NGF), interferon-γ (IFN-γ), transforming growth factor-β1 (TGF-β1) and matrix metalloproteinase-9 (MMP-9) in collected tears were measured by multiplex antibody microarray. RESULTS: Central corneal sensitivity was reduced in both groups, but the scores in the SMILE group were higher than those in the FLEx group at all time points postoperatively (P<0.01). Lower FL scores and longer NI-BUT were observed in the SMILE group 1 week after surgery (P<0.05). OSDI scores in both groups increased rapidly at 1 day and 1 week postoperatively, then returned to their preoperative levels within 1 month (P<0.05). There were no significant differences in SIT or tear meniscus height between the two groups. Lower and faster recovery of tear NGF, TGF-β1 and IL-1α concentration were found in the SMILE group compared to the FLEx group postoperatively. No significant difference was found in tear TNF-α, IFN-γ and MMP-9 for either group before or after surgery. Tear NGF, TGF-β1 and IL-1α show a correlation with ocular surface changes after FLEx or SMILE surgery. CONCLUSION: SMILE has superiority over FLEx in early ocular surface changes and NGF, TGF-β1 and IL-1α may contribute to the process of ocular surface recovery. TRIAL REGISTRATION: ClinicalTrials.gov NCT02540785.

Veldman PB, Dye PK, Holiman JD, Mayko ZM, Sáles CS, Straiko MD, Stoeger CG, Terry MA. Stamping an S on DMEK Donor Tissue to Prevent Upside-Down Grafts: Laboratory Validation and Detailed Preparation Technique Description. Cornea 2015;34(9):1175-8.Abstract

PURPOSE: To report endothelial cell loss (ECL) caused by a novel S-stamp preparation technique for Descemet membrane endothelial keratoplasty (DMEK). METHODS: Six cadaveric human corneas were prepared for DMEK transplantation using a single standardized technique, including the application of a dry ink gentian violet S-stamp to the stromal side of Descemet membrane. Endothelial cell death was evaluated and quantified using computerized analysis of vital dye staining. RESULTS: ECL caused by the S-stamp was 0.6% (range 0.1%-1.0%), which comprised less than one-tenth of the total ECL caused by our preparation of the DMEK graft from the start to finish, including recovery, prestripping, S-stamping, and trephination (13.7% total ECL, range 9.9%-17.6%). CONCLUSIONS: Our novel S-stamp donor tissue preparation technique is intuitive to learn and holds the promise of preventing iatrogenic primary graft failure due to upside-down grafts without causing unacceptable increases in ECL.

Theophanous C, Jacobs DS, Hamrah P. Corneal Neuralgia after LASIK. Optom Vis Sci 2015;92(9):e233-40.Abstract

PURPOSE: To illustrate that corneal neuralgia may be the basis for refractory dry eye syndrome after laser-assisted in situ keratomileusis (LASIK). METHODS: The methodology used is that of a retrospective medical record review of a small case series. RESULTS: Three male patients, aged 30 to 48 years, referred in 2012 for dry eye syndrome refractory to treatment within 1 year of LASIK or LASIK enhancement are reported. Each patient gave history of eye pain, light sensitivity, and difficulty with visual activities beginning within 2 months of LASIK or LASIK enhancement. Best-corrected visual acuity was 20/15 or 20/20 in each of the six eyes. Tear-centered models and metrics did not explain persistent symptoms, which was consistent with inadequate response to standard dry eye treatments used before referral and reported here. In vivo confocal microscopy was abnormal at presentation in each case and was followed over time. Treatments undertaken subsequent to referral included autologous serum tears (three cases), PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) treatment (two cases), and systemic agents for pain, anxiety, or depression (three cases). By the end of 2013, at a mean of 23 months after LASIK or LASIK enhancement, symptoms improved in all three patients. CONCLUSIONS: Patients with persistent dry eye symptoms out of proportion to clinical signs after LASIK have a syndrome that may best be classified as corneal neuralgia. In vivo confocal microscopy can be informative as to the neuropathic basis of this condition. In keeping with current understanding of complex regional pain syndrome, early multimodal treatment directed toward reducing peripheral nociceptive signaling is warranted to avoid subsequent centralization and persistence of pain. Distinguishing this syndrome from typical post-LASIK dry eye remains a challenge.

Robert M-C, Khreim N, Todani A, Melki SA. Anterior chamber gas bubble emergence pattern during femtosecond LASIK-flap creation. Br J Ophthalmol 2015;99(9):1201-5.Abstract

AIM: To characterise the emergence pattern of cavitation bubbles into the anterior chamber (AC) following femtosecond laser-assisted in situ keratomileusis (LASIK)-flap creation METHODS: Retrospective review of patients undergoing femtosecond LASIK surgery at Boston Laser, a private refractive surgery practice in Boston, Massachusetts, between December 2008 and February 2014. Patient charts were reviewed to identify all cases with gas bubble migration into the AC. Surgical videos were examined and the location of bubble entry was recorded separately for right and left eyes. RESULTS: Five thousand one hundred and fifty-eight patients underwent femtosecond LASIK surgery. Air bubble migration into the AC, presumably via the Schlemm's canal and trabecular meshwork, occurred in 1% of cases. Patients with AC bubbles had an average age of 33±8 years with a measured LASIK flap thickness of 96±21 μm. The occurrence of gas bubbles impaired iris registration in 64% of cases. Gas bubbles appeared preferentially in the nasal or inferior quadrants for right (92% of cases) and left (100% of cases) eyes. This bubble emergence pattern is significantly different from that expected with a random distribution (p<0.0001) and did not seem associated with decentration of the femtosecond laser docking system. CONCLUSIONS: The migration of gas bubbles into the AC is a rare occurrence during femtosecond laser flap creation. The preferential emergence of gas bubbles into the nasal and inferior quadrants of the AC may indicate a distinctive anatomy of the nasal Schlemm's canal.