Safety of office-based lens surgery: U.S. multicenter study.

PURPOSE: To evaluate the rate of adverse events after office-based lens surgery performed across multiple private practices in the United States. SETTING: 36 private practices across the U.S. DESIGN: Retrospective multicenter study. METHODS: This analysis included case records of all consecutive patients who underwent office-based lens surgery for visually significant cataract, refractive lens exchange, or phakic intraocular lens implantation between August 2020 and May 2022 at 36 participating sites across the U.S. The study outcome measures included the assessment of intraoperative and postoperative complications such as the incidence of unplanned vitrectomy, iritis, corneal edema, and endophthalmitis after lens surgery. The frequency of patients requiring a return to the operating room (OR) or referral to a retina surgeon and the frequency of patients requiring hospitalization or calling emergency services (911) for any reason were also evaluated. RESULTS: The study reviewed 18 005 cases of office-based cataract or refractive lens surgery performed at 36 clinical sites. The rates of postoperative endophthalmitis, toxic anterior segment syndrome, and corneal edema were 0.028%, 0.022%, and 0.027%, respectively. Unplanned anterior vitrectomy was performed in 0.177% of patients. Although 0.067% of patients needed to return to the OR, 0.011% of patients were referred to the hospital. CONCLUSIONS: The rate of adverse events for office-based cataract or refractive lens surgery is similar to or less than the reported adverse event rate for modern cataract surgery in the ambulatory surgery center setting.

Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization After Photorefractive Keratectomy: A Randomized, Masked Prospective Study.

Purpose: To compare, in a masked manner, a novel cross-linked hyaluronic acid ocular bandage gel (OBG) versus standard-of-care bandage contact lens (BCL) plus artificial tears with respect to safety and effectiveness in healing epithelial defects created for photorefractive keratectomy (PRK). Methods: This was a randomized, reading center-masked, exploratory study. Forty-five patients (myopic without significant anisometropia) scheduled for bilateral PRK (9-mm epithelial defect) were randomized post-PRK to treatment with OBG 8 times daily for 3 days, followed by 4 times daily for 11 days (Group 1); OBG 4 times daily for 14 days (Group 2); or BCL and artificial tears (Control). A masked reading center used image analysis of digital slit lamp photos of the fluorescein-stained cornea to evaluate defect size during the 14-day postoperative follow-up period. Effectiveness endpoints were (1) time to complete closure of the corneal defect and (2) proportion of patients with complete healing on day 3 postoperatively, whose defect remained closed. Safety assessments included findings for adverse events and vision, Standard Patient Evaluation of Eye Dryness (SPEED™) Questionnaire, slit lamp, intraocular pressure, and fundus examinations. Results: The proportion of patients with complete healing at 3 days was 73.3%, 86.7%, and 66.7% of patients in Groups 1, 2, and Control, respectively. On day 2, the mean wound size was 6%-26% smaller in Groups 1 and 2 compared with Control. No safety concern arose. SPEED scores were not significantly different across groups. Conclusion: OBG offers a well-tolerated and effective therapy for quickly reepithelializing the cornea following trauma, disease, or surgery.

Topography-Guided Refractive Astigmatism Outcomes: Predictions Comparing Three Different Programming Methods.

PURPOSE: To identify the laser programming strategy that will achieve optimal refractive outcomes of LASIK with a topography-guided laser for eyes with a disparity between cylinder measured by manifest refraction and cylinder measured by topography. SETTING: Six surgeons at 5 clinical sites in the USA. DESIGN: Retrospective data review. METHODS: Preoperative, treatment, and postoperative data on 52 eyes that underwent topography-guided LASIK with the WaveLight EX500 Contoura® Vision excimer laser ablation profile in which the vectors representing the preoperative refractive cylinder and the cylinder measured by the WaveLight® Topolyzer™ VARIO Diagnostic Device (Vario cylinder) differed by >/= 0.50D and/or >/= 10 degrees of orientation were analyzed retrospectively. Data were contributed by six surgeons using the laser at 5 different clinical sites. Vector analysis of postoperative cylindrical refractive error and the actual laser programming strategy was used to calculate the cylindrical correction that would, theoretically, have completely eliminated postoperative refractive cylinder. This was compared to expected results using the preoperative manifest cylinder, the topographic cylinder, and the Phorcides Analytic Engine (Phorcides LLC, North Oaks MN; Phorcides). For analysis, subjects were stratified on the basis of the vector difference between Manifest and Topo cylinder (High, >0.75 D; and Low, ≤0.75 D). RESULTS: The poorest calculated theoretical outcomes were obtained with the manifest refraction (centroid: -0.43, 0.22; mean calculated error vector: 0.56 ± 0.42 D; p=ns). Better outcomes were obtained with the topographically measured refraction (centroid: 0.37, 0.02; mean calculated error vector: 0.47 ± 0.33 D; p=ns). The best outcomes were obtained with Phorcides (centroid: -0.15, 0.06; mean calculated error vector: 0.39 ± 0.28 D; p=ns). The mean error vector magnitude in the Phorcides Low group was significantly lower than for the Manifest and Topo Low groups (0.26 D vs 0.48 D and 0.33 D; p<0.01). The mean error magnitude in the Phorcides High group was nearly 0.25 D lower than for the Manifest High group (0.48 D vs 0.70 D; p<0.01), but was the same as for the Topo High group (0.48 D vs 0.48 D). CONCLUSION: Our study suggests that using the topographically measured cylinder or the cylinder selected by Phorcides will produce more desirable refractive outcomes than entry of the preoperative refractive cylinder as the basis for correction of myopia and myopic astigmatism with the WaveLight Contoura Vision excimer laser.

Evaluation of the small-aperture intracorneal inlay: Three-year results from the cohort of the U.S. Food and Drug Administration clinical trial.

PURPOSE: To evaluate the safety and effectiveness of the Kamra small-aperture intracorneal inlay. SETTING: Centers in North America, Europe, Asia, and Australia. DESIGN: Prospective clinical trial. METHODS: Patients with emmetropic presbyopia had intracorneal implantation of the inlay in the nondominant eye. RESULTS: The study comprised 507 patients with emmetropic presbyopia who were aged 45 to 60 years old. The implanted eyes exhibited 3.5 diopters of defocus range above 20/40, with 363 (87.1%) of 417 patients and 391 (93.8%) of 417 patients having 20/40 or better monocular and binocular uncorrected near visual acuity (UNVA) at 36 months, respectively. Patients implanted via a femtosecond laser pocket procedure using a spot/line setting of 6 µm × 6 µm demonstrated further improved near vision, with 131 (90.3%) of 145 patients and 137 (94.5%) of 145 of patients having 20/40 or better monocular and binocular UNVA, respectively. Uncorrected distance visual acuity 20/25 or better was maintained in 135 (93.1%) of 145 of implanted eyes and 100% (145) of 145 of implanted eyes binocularly at 36 months. Less than 1.5% of eyes had a loss of 2 or more lines of corrected distance visual acuity for 3 months or more at any time after surgery. Forty-four inlays (8.7%) were removed from the full cohort over 3 years. The removal rate was significantly less in the 6 × 6 pocket group (3.0% for visual complaints) and further reduced with deeper implantation (0%). Less than 1.0% of the patients reported severe glare or halos postoperatively. CONCLUSION: The small-aperture corneal inlay was found to be safe and effective, improving near vision both monocularly and binocularly with minimal effect on distance visual acuity.

Ability of a new crosslinked polymer ocular bandage gel to accelerate reepithelialization after photorefractive keratectomy.

PURPOSE: To evaluate the safety and performance of a crosslinked thiolated carboxymethyl hyaluronic acid liquid-gel (CMHA-S) ocular bandage gel in accelerating reepithelialization of corneal defects created for photorefractive keratectomy (PRK). SETTING: Three community-based clinical research sites. DESIGN: Prospective case series. METHODS: Patients scheduled for bilateral PRK had both eyes randomized immediately after PRK to Group 1 (ocular bandage gel 4 times a day for 14 days and bandage contact lens), Group 2 (ocular bandage gel 4 times a day for 14 days), or Group 3 (control; bandage contact lens and artificial tears 4 times a day for 14 days). Patients received a 9.0 mm epithelial defect for PRK and were followed through 28 days postoperatively. Safety assessments included adverse events, vision, pain, slitlamp, intraocular pressure, and fundus examinations. The primary performance endpoint was time to corneal reepithelialization after PRK. RESULTS: The study comprised 39 patients. The ocular bandage gel was well tolerated. The time to reepithelialization was 3 days for 54.5%, 80.0%, and 45.5% of patients in Group 1, Group 2, and Group 3, respectively. Compared with measurements in the control group, the mean horizontal and vertical defect lengths in Group 2 (ocular bandage gel alone) were 36.9% and 29.0% smaller, respectively, by 1 day. CONCLUSION: Crosslinked hyaluronic acid showed the ability to quickly reepithelialize the cornea and may promise a well-tolerated and effective therapy for ocular wound care after trauma, disease, or surgery.

Meta-analysis of the FDA Reports on Patient-Reported Outcomes Using the Three Latest Platforms for LASIK.

PURPOSE: To analyze the impact of the three latest U.S. Food and Drug Administration (FDA)-approved lasers on patient-reported outcomes after LASIK. METHODS: In this meta-analysis of patient-reported FDA data, an aggregated total of 718 eyes undergoing LASIK using VISX iDesign (Abbott Medical Optics Manufacturing, Milpitas, CA), Alcon Contoura (Alcon Research, Ltd., Fort Worth, TX), and Nidek CATz (Nidek Co. Ltd., Gamagori, Japan) lasers were evaluated for overall changes in visual symptoms postoperatively. Statistical significance was calculated when appropriate to assess changes. A P value of less than .05 was considered statistically significant. RESULTS: At 12 months following LASIK, there was a decrease in the postoperative difficulty driving at night (29%) with respect to preoperative values. There was a significant postoperative reduction in prior moderate to severe symptoms for light sensitivity (9%), difficulty driving at night (22%), reading difficulty (8%), double vision (2%), glare (12%), and halos (6%) at 12 months following LASIK. CONCLUSIONS: Analysis of the FDA data shows that modern lasers have significantly improved patient-reported visual outcomes after LASIK. [J Refract Surg. 2017;33(6):362-368.].

U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery.

PURPOSE: To evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of corneal ectasia after laser refractive surgery. DESIGN: Prospective, randomized, multicenter, controlled clinical trial. PARTICIPANTS: One hundred seventy-nine subjects with corneal ectasia after previous refractive surgery. METHODS: The treatment group underwent standard CXL, and the sham control group received riboflavin alone without removal of the epithelium. MAIN OUTCOME MEASURES: The primary efficacy criterion was the change over 1 year of topography-derived maximum keratometry (K), comparing treatment with control groups. Secondary outcomes evaluated were corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), manifest refraction spherical equivalent, endothelial cell count, and adverse events. RESULTS: In the crosslinking treatment group, the maximum K value decreased by 0.7 diopters (D) from baseline to 1 year, whereas there was continued progression in the control group (1.3 D difference between treatment and control, P < 0.0001). In the treatment group, the maximum K value decreased by 2.0 D or more in 14 eyes (18%) and increased by 2.0 D or more in 3 eyes (4%). The CDVA improved by an average of 5.0 logarithm of the minimum angle of resolution (logMAR) letters. Twenty-three eyes (32%) gained and 3 eyes (4%) lost 10 or more logMAR letters. The UDVA improved 4.5 logMAR letters. Corneal haze was the most frequently reported crosslinking-related adverse finding. CONCLUSIONS: Corneal collagen crosslinking was effective in improving the maximum K value, CDVA, and UDVA in eyes with corneal ectasia 1 year after treatment, with an excellent safety profile. CXL is the first approved procedure to diminish progression of this ectatic corneal process.

United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment.

PURPOSE: To evaluate the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus. DESIGN: Prospective, randomized, multicenter, controlled clinical trial. PARTICIPANTS: Patients with progressive keratoconus (n = 205). METHODS: The treatment group underwent standard CXL and the sham control group received riboflavin alone without removal of the epithelium. MAIN OUTCOME MEASURES: The primary efficacy criterion was the change over 1 year of topography-derived maximum keratometry value, comparing treatment with control group. Secondary outcomes evaluated were corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), manifest refraction spherical equivalent, endothelial cell count, and adverse events. RESULTS: In the CXL treatment group, the maximum keratometry value decreased by 1.6 diopters (D) from baseline to 1 year, whereas keratoconus continued to progress in the control group. In the treatment group, the maximum keratometry value decreased by 2.0 D or more in 28 eyes (31.5%) and increased by 2.0 D or more in 5 eyes (5.6%). The CDVA improved by an average of 5.7 logarithm of the minimum angle of resolution (logMAR) units. Twenty-three eyes (27.7%) gained and 5 eyes lost (6.0%) 10 logMAR or more. The UDVA improved 4.4 logMAR. Corneal haze was the most frequently reported CXL-related adverse finding. There were no significant changes in endothelial cell count 1 year after treatment. CONCLUSIONS: Corneal collagen crosslinking was effective in improving the maximum keratometry value, CDVA, and UCVA in eyes with progressive keratoconus 1 year after treatment, with an excellent safety profile. Corneal collagen crosslinking affords the keratoconic patient an important new option to decrease progression of this ectatic corneal process.

Comparison and analysis of FDA reported visual outcomes of the three latest platforms for LASIK: wavefront guided Visx iDesign, topography guided WaveLight Allegro Contoura, and topography guided Nidek EC-5000 CATz.

PURPOSE: To compare and analyze the differences in visual outcomes between Visx iDesign Advanced WaveScan Studio™ System, Alcon Wavelight Allegro Topolyzer and Nidek EC-5000 using Final Fit™ Custom Ablation Treatment Software from the submitted summary of safety and effectiveness of the US Food and Drug Administration (FDA) data. METHODS: In this retrospective comparative study, 334 eyes from Visx iDesign, 212 eyes from Alcon Contour, and 135 eyes from Nidek CATz platforms were analyzed for primary and secondary visual outcomes. These outcomes were compared via side-by-side graphical and tabular representation of the FDA data. Statistical significance was calculated when appropriate to assess differences. A P-value <0.05 was considered statistically significant. RESULTS: The mean postoperative uncorrected distance visual acuity (UDVA) at 12 months was 20/19.25±8.76, 20/16.59±5.94, and 20/19.17±4.46 for Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. In at least 90% of treated eyes at 3 months and 12 months, all three lasers showed either no change or a gain of corrected distance visual acuity (CDVA). Mesopic contrast sensitivity at 6 months showed a clinically significant increase of 41.3%, 25.1%, and 10.6% for eyes using Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. Photopic contrast sensitivity at 6 months showed a clinically significant increase of 19.2%, 31.9%, and 10.6% for eyes using Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. CONCLUSION: FDA data for the three platforms shows all three were excellent with respect to efficacy, safety, accuracy, and stability. However, there are some differences between the platforms with certain outcome measurements. Overall, patients using all three lasers showed significant improvements in primary and secondary visual outcomes after LASIK surgery.

Short-term visual result after simultaneous photorefractive keratectomy and small-aperture cornea inlay implantation.

PURPOSE: To report the short-term results of simultaneous photorefractive keratectomy (PRK) and small-aperture cornea inlay implantation (KAMRA) surgery in treating presbyopia. METHODS: Simultaneous PRK and KAMRA inlay surgery was performed on 21 patients from July 2015 to March 2016. Follow-up exams were conducted at 1, 3, and 6 months postoperatively. Our patients were also divided preoperatively into three categories: myopic, hyperopic, and emmetropic. Over the 6-month period, the main outcome measures were uncorrected near visual acuity (UNVA), changes in best-corrected distance visual acuity, and mean spherical equivalent refraction. RESULTS: At 6-month follow-up, 83% (10/12) of patients had a monocular UNVA of 20/40 or better, and 75% had a binocular UNVA of 20/40 (J5) or better. At 6 months, the overall mean refractive spherical equivalent (MRSE) was -0.60 D (±0.42 standard deviation [SD], range: -1.38 to -0.13) with a mean change of -0.43 D (±1.19 SD, range: -1.5 to 2.63) compared to preoperative data. Overall, 91% (10/11) of patients were within a ±0.5 D range of our target -0.75 D for KAMRA use. One-hundred percent (5/5) of the hyperopes, 50% (1/2) of emmetropes, and 100% (4/4) of myopes met the targeted range. At 6 months, the MRSE for the hyperopic subgroup (n=5) was 0.33 D (±0.20 SD), the MRSE for the emmetropic subgroup (n=2) was -1.19 D (±0.19 SD), and the MRSE for the myopic subgroup (n=4) was -0.66 D (±0.36 SD). CONCLUSION: Based on preliminary results and a small sample size, it seems that simultaneous PRK and KAMRA is effective and predictable. There are multiple advantages in performing simultaneous PRK and KAMRA including a shorter recovery time and less steroid use than the two surgeries performed separately.

Three-Year Longitudinal Survey Comparing Visual Satisfaction with LASIK and Contact Lenses.

PURPOSE: To assess patient satisfaction and perceived outcomes with different methods of refractive error correction through annual surveys administered over a 3-year period. DESIGN: Prospective, longitudinal, parallel-group, multicenter survey. PARTICIPANTS: A total of 1800 subjects, aged 18 to 60 years, who had LASIK or continued using contact lenses. METHODS: Twenty sites across the United States enrolled subjects who completed a study-specific baseline survey during a contact lens examination or while being evaluated as a candidate for LASIK. Links to follow-up surveys were emailed annually for 3 years. Between-group differences were assessed by analysis of variance, and associations were assessed by logistic multivariate regression. MAIN OUTCOME MEASURES: Visual satisfaction. RESULTS: Of 1800 subjects, 694 (39%) comprised the control group who continued contact lens wear, 819 (45%) wore contacts at baseline and had LASIK, and 287 (16%) wore glasses at baseline and had LASIK. Most contact lens users had worn them successfully ≥5 years. The proportion expressing strong satisfaction with their current vision correction method decreased from 63% at baseline to 54% at year 3 in the contact lens control group, whereas 88% of former contact lens wearers and 77% of former glasses wearers were strongly satisfied with LASIK at year 3. Patients 40 years of age or younger when they had LASIK were somewhat more likely to be strongly satisfied than older patients. LASIK significantly reduced difficulties with night driving and nighttime visual disturbances among former contact lens users and former glasses users. The proportion with dry eye symptoms at 1, 2, or 3 years after LASIK was not significantly increased relative to baseline contact lens wear but was significantly increased relative to baseline glasses use, consistent with many glasses users having tried and abandoned contact lenses because of latent dry eye problems. Compared with continued contact lens wear, LASIK significantly reduced the self-reported rates of eye infections, ulcers, and abrasions each year. CONCLUSIONS: Compared with contact lens wear, current LASIK technology improved ease of night driving, did not significantly increase dry eye symptoms, and resulted in higher levels of satisfaction at 1, 2, and 3 years follow-up.

Removability of a small aperture intracorneal inlay for presbyopia correction.

PURPOSE: To evaluate the safety of the corneal inlay removal procedure and the reversibility of visual acuities, corneal topography, and corneal biomicroscopy changes in a series of cases. METHODS: Ten cases implanted with one of three versions of the AcuFocus Kamra Inlay (ACI 7000, 7000T, and 7000PDT; AcuFocus, Inc., Irvine, CA) were followed for a minimum of 6 months after corneal inlay removal. RESULTS: The reason for removal was related to subjective dissatisfaction with visual symptoms (8 of 10 patients) such as night glare, photophobia, starburst, blurry vision, and halos. One case of removal was related to inadvertent thin flap and the final case was related to insufficient near vision. Mean uncorrected distance visual acuity (UDVA) and uncorrected near visual acuity (UNVA) was 0 ± 0.1 logMAR (Snellen 20/20) and 0.5 ± 0.2 logMAR (Snellen 20/40), respectively, preoperatively and 0.1 ± 0.1 logMAR (Snellen 20/25) and 0.5 ± 0.1 logMAR (Snellen 20/63), respectively, 6 months after corneal inlay removal. Mean corrected distance visual acuity (CDVA) and corrected near visual acuity (CNVA) was 0 ± 0.1 logMAR (Snellen 20/20) and 0 ± 0.1 logMAR (Snellen 20/20), respectively, preoperatively and 0 ± 0.1 logMAR (Snellen 20/20) and 0.1 ± 0.1 logMAR (Snellen 20/25), respectively, 6 months after corneal inlay removal. Mean root mean square (RMS) higher-order aberration (HOA) was 0.50 ± 0.12 (range: 0.30 to 0.70) preoperatively and 0.69 ± 0.14 (range: 0.48 to 0.95) 6 months after corneal inlay removal (P < .8). Weak positive correlation was found between Δt Implant-Removal (Δt I-R), RMS spherical, coma, and HOA at 6 months (Δt I-R vs RMS spherical was r = 0.2, r(2) = 0.5, P < .7; Δt I-R vs RMS coma was r = 0.8, r(2) = 0.6, P < .3; and Δt I-R vs HOA r = 0.8; r(2) = 0.6, P < .9). CONCLUSION: This study suggests that after removal of the corneal inlay, corneal topography and corneal aberrometry are not permanently affected. In more than 60% of patients, CNVA, CDVA, UNVA, and UDVA were similar to the preoperative value.

Dilute brimonidine to improve patient comfort and subconjunctival hemorrhage after LASIK.

PURPOSE: To investigate whether dilute brimonidine (0.025%) reduces patient discomfort, subconjunctival hemorrhage, and injection after LASIK without a significant increase in the rate of flap complications or surgical enhancements. METHODS: This randomized, double-blind, prospective study enrolled 180 patients (360 eyes) in a contralateral eye comparison of topical dilute brimonidine, naphazoline/pheniramine, or Systane Ultra (Alcon Laboratories, Inc., Fort Worth, TX) administered shortly before LASIK for any indication. Patients were evaluated for subconjunctival hemorrhage, injection, and flap dislocation 1 hour and 1 day postoperatively. Patient questionnaires measuring patient comfort and ocular symptoms were administered at these same follow-up visits. Patients were examined for 3 months to determine similar outcomes for standard indices of safety, predictability, efficacy, and enhancement rates. RESULTS: Scores of patient discomfort, subconjunctival hemorrhage, and injection were significantly lower in eyes treated with dilute brimonidine at the 1 hour and 1 day postoperative examinations. Refloats for mild-flap edge wrinkling were required in 3 brimonidine eyes (2.5%), 1 naphazoline/pheniramine eye (0.8%), and no control eyes, but this difference did not reach statistical significance (P = .18). There was no significant difference between eyes at 3 months in terms of visual acuity, refractive error, corrected distance visual acuity, or rate of enhancement. CONCLUSIONS: Use of dilute brimonidine before LASIK reduces subconjunctival hemorrhage and injection and improves patient comfort after surgery. Flap edge wrinkling requiring refloat may still be a complication with dilute brimonidine.

Evaluating the speed of visual recovery following thin-flap LASIK with a femtosecond laser.

PURPOSE: To investigate the speed of visual recovery following myopic thin-flap LASIK with a femtosecond laser. METHODS: This pilot study prospectively evaluated 20 eyes from 10 patients who underwent bilateral simultaneous LASIK with the Femto LDV Crystal Line femtosecond laser (Ziemer Ophthalmic Systems AG) used to create a circular flap of 9.0-mm diameter and 110-µm thickness followed by photoablation with the Allegretto Wave Eye-Q (WaveLight AG) excimer laser. Binocular and monocular uncorrected distance visual acuity (UDVA), monocular contrast sensitivity, and a patient questionnaire were evaluated during the first hours, 1 day, and 1 month postoperatively. RESULTS: For monocular UDVA, 100% of eyes were 20/40 at 1 hour and 100% were 20/25 at 4 hours. For binocular UDVA, all patients achieved 20/32 by 30 minutes and 20/20 by 4 hours. Low frequency contrast sensitivity returned to preoperative baseline by 1 hour (P=.73), and showed a statistically significant improvement over baseline by 4 hours (P=.01). High frequency monocular contrast sensitivity returned to preoperative baseline by 4 hours (P=.48), and showed a statistically significant improvement by 1 month (P=.04). At 2 and 4 hours, 50% and 100% of patients, respectively, indicated that they would feel comfortable driving. CONCLUSIONS: Visual recovery after thin-flap femtosecond LASIK is rapid, occurring within the first few hours after surgery.

Corneal endothelial cell density after myopic intra-LASIK and the effect of AC gas bubbles on the corneal endothelium.

PURPOSE: To evaluate the endothelial cell density (ECD) change after laser-assisted in situ keratomileusis (LASIK) using IntraLase FS30® and the influence of anterior chamber gas bubbles (AC gas bubbles) produced during flap creation on the corneal endothelium during the excimer laser ablation. METHODS: Myopic LASIK was performed in 436 eyes of 252 patients at Shinagawa LASIK Center. Average age was 32.4±7.05 years. IntraLase FS30® was used for flap creation and Allgretto Wave Eye-Q® 400Hz was used for excimer laser ablation. Preoperative and 3-month postoperative ECD were measured with a noncontact specular microscope (Noncon Robo FA-3509®) and compared. The preoperative and 3-month postoperative ECD changes that developed AC gas bubbles during the flap creation (19 eyes of 18 patients) were also examined. The change of ECD was compared to the group that did not produce AC gas bubbles. RESULTS: The average ECD reduction after LASIK was -15±102 cells/mm2 for AC gas bubbles (-) group (0.51%, p>0.05) and -35±130 cells/mm2 (1.21%, p>0.05) for AC gas bubbles (+) group. There was no significant ECD change in the AC gas bubbles (-) and AC gas bubbles (+) groups, and no significant difference was observed between AC gas bubbles (-) and AC gas bubbles (+) groups. CONCLUSIONS: IntraLase FS30® is a safe and effective tool for LASIK operation which does not cause damage to corneal endothelium. Anterior chamber gas bubbles produced during flap creation did not damage corneal endothelial cells and did not interfere with LASIK operations.

Comparing conventional and wavefront-optimized LASIK for the treatment of hyperopia.

PURPOSE: To compare differences in visual outcomes and induced spherical aberration after conventional and wavefront-optimized LASIK for the treatment of hyperopia. METHODS: In a prospective, randomized, single-center clinical trial, 51 consecutive eyes underwent LASIK for the treatment of hyperopia. Eyes were divided between groups treated with conventional LASIK with the Alcon LADAR4000 excimer laser (n=25) and wavefront-optimized LASIK with the WaveLight ALLEGRETTO excimer laser (n=26). Refractive and visual outcomes, induced spherical aberrations, and contrast sensitivity were analyzed. RESULTS: On postoperative day 1, 20% of eyes treated with a conventional profile had uncorrected visual acuity (UCVA) of 20/20 or better compared to 65% of eyes receiving wavefront-optimized treatment (P=.0011). By 6 months, UCVA was 20/20 or better in 72% and 84% of the conventional and wavefront-optimized treatment groups, respectively (P=.3254). At 6 months, the manifest refraction spherical equivalent was -0.21+/-0.47 diopters (D) and 0.16+/-0.27 D (P=.6469) whereas the cylinder was -0.41+/-0.47 D and -0.17+/-0.27 D (P=.0332) for the conventional and wavefront-optimized treatment groups, respectively. Induced spherical aberration was -0.54+/-0.32 microm and -0.42+/-0.21 microm for the conventional and wavefront-optimized treatment groups, respectively (P=.1195). The respective change in mesopic and photopic area under the log contrast sensitivity function was -0.05+/-0.29 and -0.05+/-0.23 for the conventional treatment group and 0.08+/-0.39 and 0.08+/-0.41 for the wavefront-optimized treatment group (P=.1970). CONCLUSIONS: Wavefront-optimized (ALLEGRETTO) and conventional (LADAR4000) ablation predictably and safely correct low to moderate hyperopia. Wavefront-optimized ablation showed superior results with regards to rapid visual recovery and residual cylinder. Although not statistically significant, a trend towards less induced negative spherical aberrations and improved mesopic and photopic contrast sensitivity was noted with wavefront-optimized treatment.

Corneal endothelial cell density after femtosecond thin-flap LASIK and PRK for myopia: a contralateral eye study.

PURPOSE: To compare the effect of femtosecond thinflap LASIK and photorefractive keratectomy (PRK) on postoperative endothelial cell density. METHODS: In a prospective, randomized, contralateral, single-center clinical trial, 25 patients (mean age: 30+/-5 years [range: 21 to 38 years]) underwent PRK in one eye and thin-flap LASIK in the fellow eye for the correction of myopia using a wavefront-guided platform. The central corneal endothelial cell density was measured using the NIDEK Confoscan 4 preoperatively, and at 1 and 3 months postoperatively. Changes in endothelial cell density were analyzed over time between the two refractive techniques. RESULTS: In PRK, the average preoperative endothelial cell density was 3011+/-329 cells/mm(2), which decreased to 2951+/-327 cells/mm(2) at 1 month (P=.5736) and 2982+/-365 cells/mm(2) at 3 months (P=.6513). In thinflap LASIK, the average preoperative endothelial cell density was 2995+/-325 cells/mm(2), which decreased to 2977+/-358 cells/mm(2) at 1 month (P=.5756) and 2931+/-369 cells/mm(2) at 3 months (P=.4106). No statistically significant difference was found between the two groups at 1 (P=.7404) or 3 (P=.3208) months postoperatively. CONCLUSIONS: No statistically significant change was noted in endothelial cell density following either PRK or thin-flap LASIK for the treatment of myopia. Furthermore, no statistically significant difference was found between the two groups out to 3 months postoperatively, indicating that thin-flap LASIK is as safe as PRK with regards to endothelial health.

A prospective, contralateral eye study comparing thin-flap LASIK (sub-Bowman keratomileusis) with photorefractive keratectomy.

PURPOSE: To determine the differences in the visual results, pain response, biomechanical effect, quality of vision, and higher-order aberrations, among other parameters, in eyes undergoing either photorefractive keratectomy (PRK) or thin-flap LASIK/sub-Bowman keratomileusis (SBK; intended flap thickness of +/-100 microm and 8.5-mm diameter) at 1, 3, and 6 months after surgery. DESIGN: A contralateral eye pilot study. PARTICIPANTS: Fifty patients (100 eyes) were enrolled at 2 sites. METHODS: The mean preoperative spherical refraction was -3.66 diopters (D) and the mean cylinder was -0.66 D for all eyes. Eyes in the PRK group underwent 8.5-mm ethanol-assisted PRK, whereas in eyes in the SBK group, an 8.5-mm, (intended) 100-microm flap was created with a 60-kHz IntraLase femtosecond laser (Advanced Medical Optics, Santa Ana, CA). All eyes underwent a customized laser ablation using an Alcon LADARVision 4000 CustomCornea excimer laser (Alcon Laboratories, Fort Worth, TX). MAIN OUTCOME MEASURES: Preoperative and postoperative tests included best spectacle-corrected visual acuity, uncorrected visual acuity (UCVA), corneal topography, wavefront aberrometry, retinal image quality, and contrast sensitivity. Patients completed subjective questionnaires at each visit. RESULTS: One- and 3-month UCVA results showed a statistically significant difference: SBK, 88% 20/20 or better vs. 48% 20/20 or better for PRK. At 6 months, UCVA was 94% 20/20 or better for PRK and 92% for SBK. At 1 and 3 months, the SBK group had lower higher-order aberrations (coma and spherical aberration; P

Association between ocular dominance and refraction.

PURPOSE: To investigate the association between ocular dominance and refraction. METHODS: A retrospective study of the cycloplegic refraction of 2453 consecutive patients with a mean age of 46 +/- 12 years (range: 18 to 79 years) was performed. One thousand one hundred fifty-seven (47%) patients were men and 1296 (53%) were women. Patients who had previous eye surgery, ocular disease, or > 2 lines of best spectacle-corrected visual acuity (BSCVA) difference between eyes were excluded. Motor ocular dominance was determined using the hole-in-the-card test. RESULTS: The right and left eyes were dominant in 67% (1650) and 33% (803) of patients, respectively. Males had a higher right eye dominance (70%) than females (65%) (P = .0168) with a mean cycloplegic spherical equivalent refracton (SE) of -2.12 diopters (D) and -2.38 D, respectively. This higher rate of right eye dominance in males was seen at all levels of SE refractive error. Mean BSCVA was 20/19 in both right and left eyes (P>.05) with a mean SE of -2.25 +/- 3.63 D and -2.26 +/- 3.66 D in the right and left eyes, respectively. Neither mean SE difference nor BSCVA difference between eyes was found to correlate with motor eye dominance. CONCLUSIONS: Gender appears to be a factor when testing ocular dominance but not SE refractive error. The hole-in-the-card dominance test is a method that is easy to perform for both patients and clinicians.