Corneal remodeling after implantation of a shape-changing inlay concurrent with myopic or hyperopic laser in situ keratomileusis.

PURPOSE: To compare the induced addition (add)-power profile and epithelial remodeling between patients receiving hyperopic and myopic laser in situ keratomileusis (LASIK) concurrently with implantation of a corneal shape-changing inlay. SETTING: Specialty clinics in Monterrey and Tijuana, Mexico. DESIGN: Retrospective case series. METHODS: Preoperative hyperopic patients (mean spherical equivalent [SE] treatment +1.71 diopters [D] ± 0.51 [SD]) and myopic patients (mean SE treatment -2.48 ± 1.33 D) had implantation of a Raindrop Near Vision Inlay in the nondominant eye immediately after the excimer laser ablation in both eyes under a corneal flap. Monocular and binocular visual acuities were recorded at 6 m. Wavefront measurement analysis yielded the mean inlay add-power profile, and optical coherence tomography images yielded the mean epithelial remodeling profile. RESULTS: In the inlay eye in the hyperopic group (n = 34) and myopic group (n = 29), the mean uncorrected near visual acuity exceeded 20/25 (85% 20/25 or better), the mean uncorrected distance visual acuity (UDVA) was 20/32 (62% 20/32 or better), and the mean binocular UDVA was 20/18 (100% 20/25 or better). The add-power profiles for the hyperopic and myopic groups were similar. The epithelial thinning profiles were also the same, thinning centrally by approximately 19 µm, and were uncorrelated with the treated refractive error. CONCLUSIONS: After concurrent LASIK and inlay implantation, the visual acuity, induced add-power profile, and epithelial remodeling were the same, regardless of hyperopic or myopic treatment.

Through-focus performance with a corneal shape-changing inlay: One-year results.

PURPOSE: To evaluate improvement in the through-focus acuity and visual function provided by a corneal inlay designed to modify the surface shape of the central cornea. SETTING: Two clinical practices, United States. DESIGN: Prospective nonrandomized clinical trial. METHODS: Emmetropic patients with presbyopia who required a reading addition (add) from +1.50 to +2.00 diopters (D) had implantation of the Raindrop Near Vision Inlay in the nondominant eye. The inlay was designed to modify the anterior curvature of the central cornea with the intent to improve near and intermediate vision. At the preoperative and 1-year postoperative visits, the following visual functions were recorded: defocus curves in the nondominant eye, required add for best near vision, distance-corrected binocular contrast sensitivity, and uncorrected and corrected visual acuity at 6 m, 80 cm, and 40 cm. RESULTS: The study comprised 30 patients. One year postoperatively, on average, distance-corrected near acuity improved by more than 3 lines, with patients achieving a distance-corrected acuity of 0.3 logMAR (20/40) or better across a 3.50 D range of defocus. Binocular uncorrected visual acuity of 0.2 logMAR (20/32) or better at distance, intermediate, and near distances was obtained in 97% of patients. The mean reduction in the reading add was 1.60 D. There was no significant change in binocular contrast sensitivity. Overall patient satisfaction was high. CONCLUSION: A corneal inlay in the nondominant eye of emmetropic patients provided a significant increase in the range of functional vision at intermediate and near, with no loss in binocular distance acuity. FINANCIAL DISCLOSURE: Drs. Whitman, Hovanesian, Steinert, and Koch received compensation for participating in the study from Revision Optics, Inc. Drs. Steinert and Koch are medical monitors for Revision Optics, Inc. None of the other authors has a financial or proprietary interest in any material or method mentioned.

Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes.

PURPOSE: To report 1-year safety and efficacy clinical outcomes of a shape-changing corneal inlay for the treatment of presbyopia. DESIGN: Prospective, nonrandomized, multicenter United States Food and Drug Administration Investigational Device Exemption clinical trial (clinicaltrials.gov identifier, NCT01373580). PARTICIPANTS: Nondominant eyes (N = 373) of emmetropic presbyopic subjects were implanted at 11 sites with the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, CA); 340 eyes underwent the 1-year follow-up visit. METHODS: The corneal inlay was implanted under a corneal flap at the center of the light-constricted pupil created with a femtosecond laser. MAIN OUTCOME MEASURES: For subjects completing the 1-year follow-up, monocular and binocular uncorrected and corrected visual acuity, refractive stability, contrast sensitivity (CS; photopic and mesopic), symptom and satisfaction questionnaire results, and adverse events. RESULTS: At 1 year in the treated eye, on average, uncorrected near visual acuity (UNVA) improved by 5.1 lines, uncorrected intermediate visual acuity (UIVA) improved by 2.5 lines, and uncorrected distance visual acuity (UDVA) decreased by 1.2 lines. From 3 months through 1 year, 93% of subjects achieved UNVA of 20/25 or better, 97% achieve UIVA of 20/32 or better, and 95% achieved UDVA of 20/40 or better. Binocularly, the mean UDVA exceeded 20/20 from 3 months through 1 year. Contrast sensitivity loss occurred only at the highest spatial frequencies, with no loss binocularly. Absent or mild scores were reported in 96% of subjects for visual symptoms (glare, halos, double vision, and fluctuations in vision), in 99% for ocular symptoms (pain, light sensitivity, and discomfort), and in 95% for dryness. Adverse events were treatable and resolved. Eighteen inlays were replaced, usually soon after implantation because of decentration, but UNVA was little affected in this group thereafter. In the 11 cases requiring inlay explantations, 100% achieved a corrected distance visual acuity of 20/25 or better by 3 months after explant. CONCLUSIONS: The Raindrop Near Vision Inlay provides significant improvement in near and intermediate visual performance, with no significant change in binocular distance vision or CS. Subject satisfaction is improved significantly with minimal ocular or visual symptoms.

Range of refractive independence and mechanism of action of a corneal shape-changing hydrogel inlay: results and theory.

PURPOSE: To demonstrate the independence of visual performance over a range of preoperative refraction and age in presbyopes implanted with a corneal shape-changing inlay (Raindrop Near Vision Inlay). SETTING: Two multispecialty clinics, Monterrey and Tijuana, Mexico. DESIGN: Prospective case series. METHODS: The nondominant eyes of patients were implanted with the hydrogel corneal inlay beneath a femtosecond flap, centered on the pupil. Clinical outcomes included uncorrected near, intermediate, and distance visual acuity (UNVA, UIVA, and UDVA) and patient-assessed task performance in good light and dim light. Statistical analyses assessed the dependencies on preoperative age (45 to 60 years) and preoperative manifest refraction spherical equivalent (MRSE) (-0.5 to +1.5 diopters [D]). Using the inlay effect derived from wavefront measurements, an eye model was created through which letter charts were simulated. RESULTS: The study evaluated eyes of 188 patients. Postoperative UNVA, UIVA, and task performance at these distances in good light was independent of age and preoperative MRSE (P > .05). Postoperative UDVA was weakly dependent on preoperative MRSE, but distance task performance in good light was not (P > .05). In the treated eye, the mean postoperative UNVA was 20/25, UIVA was 20/25, and UDVA was 20/32. The clinical outcomes are explained by consideration of zones within the pupil generating good near, intermediate, and distance image quality. This was confirmed by visual acuity simulations. CONCLUSIONS: The continuous center-near power profile induced by the corneal shape-changing inlay provides good visual acuity and performance from distance through near over a 2.0 D range of preoperative refraction and presbyopic age. FINANCIAL DISCLOSURE: Drs. Steinert, Schwiegerling, Barragán-Garza, and Chayet are consultants to Revision Optics, Inc. Drs. Lang and Holliday and Mr. Roy are employees of Revision Optics, Inc. Drs. Steinert, Schwiegerling, Barragán-Garza, and Chayet have no financial or proprietary interest in any material or method mentioned.

Reduction in mean deviation values in automated perimetry in eyes with multifocal compared to monofocal intraocular lens implants.

PURPOSE: To evaluate differences in mean deviation values in automated perimetry in healthy eyes with multifocal compared to monofocal intraocular lens (IOL) implants. DESIGN: Prospective, age-matched, comparative analysis. SETTING: Single-center, tertiary referral academic practice. PATIENT POPULATION: A total of 37 healthy eyes in 37 patients with bilateral multifocal (n=22) or monofocal (n=15) IOL implants were studied. INTERVENTION/OBSERVATION PROCEDURE: Humphrey Visual Field 10-2 testing was performed on all patients. MAIN OUTCOME MEASURES: Mean deviation (MD) and pattern standard deviation (PSD) numerical values were evaluated and compared between groups. RESULTS: The average MD was -2.84 dB (SD 2.32) for the multifocal IOL group and -0.97 dB (SD 1.58) for the monofocal IOL group (P=.006). There was no significant difference in PSD between the 2 groups (P=.99). Eyes that had the visual field 10-2 testing≥6 months from time of IOL placement showed no improvement in MD when compared to eyes that were tested within 6 months from IOL placement. CONCLUSION: Multifocal IOL implants cause significant nonspecific reduction in MD values on Humphrey Visual Field 10-2 testing that does not improve with time or neuroadaptation. Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma.

Results of toric intraocular lenses for post-penetrating keratoplasty astigmatism.

PURPOSE: Evaluate the usefulness of toric intraocular lens (IOL) implantation during cataract surgery in patients after penetrating keratoplasty (PKP). DESIGN: Retrospective case review. PARTICIPANTS: A total of 21 eyes of 16 patients with prior PKP and moderate to high regular astigmatism after full suture removal underwent phacoemulsification and implantation of a single-piece acrylic toric IOL (SN6AT series; Alcon, Fort Worth, TX). METHODS: Patients underwent comprehensive examinations at standard intervals, including visual acuity, manifest refraction, and corneal topography. MAIN OUTCOME MEASURES: Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) expressed as the logarithm of the minimum angle of resolution (logMAR) and manifest refraction astigmatism. RESULTS: From preoperatively to the last visit (mean, 14.7 ± standard deviation 12.8 months), the 21 eyes had significant improvement in UDVA (logMAR, 0.90 ± 0.48 to 0.23 ± 0.25; P = 0.0001) and CDVA (logMAR, 0.31 ± 0.14 to 0.08 ± 0.13; P = 0.0001). A total of 14 of 21 eyes (67%) and 17 of 21 eyes (81%) had UDVA and CDVA of ≥ 20/30, respectively. Preoperative topographic astigmatism was 4.57 ± 2.05 diopters (D). Postoperative manifest refraction astigmatism was 1.58 ± 1.25 D overall, but lower (0.75 ± 0.54 D) in the T7-T9 subgroup (excluding 1 outlier whose corneal astigmatism doubled after surgery) than in the T4-T6 subgroup (1.88 ± 1.28 D; P = 0.013). A total of 16 of all 21 eyes (76.2%) and 8 of 9 eyes (89%) in the T7-T9 subgroup were within 1 D of postoperative manifest astigmatism as predicted or better. CONCLUSIONS: Toric IOLs placed during cataract surgery after PKP and full suture removal can reduce manifest refraction cylinder to predictably low levels with corresponding improvement in UDVA and CDVA in patients with moderate to high regular preoperative topographic astigmatism.

Prevalence of positive microbiology results from donor cornea tissue in different methods of corneal transplantation.

PURPOSE: To evaluate the prevalence of positive microbiology results (culture and/or Gram stain) in donor cornea tissue with newer transplant methods and to assess if the results subsequently correlate with higher incidence of clinical infection. METHODS: A retrospective review of the microbiology records of 569 consecutive corneal transplants from July 2006 through July 2010 was performed to evaluate positive microbiology results in routine evaluation of cornea donor tissue. RESULTS: Microbiologic results were available for 544 of 569 transplants. The remaining 25 cases did not have specimens submitted for microbiologic analysis. In cases with results available, 46 (8.5%) positive reports occurred. In 10 of the 46 cases, Gram stain results were positive with subsequent negative cultures. Analysis revealed that the prevalence of positive results was 6 in 137 (4.4%), 14 in 127 (11.0%), and 26 in 271 (9.6%) for femtosecond laser-enabled keratoplasty, Descemet stripping automated endothelial keratoplasty, and conventional penetrating keratoplasty, respectively; 9 femtosecond deep anterior lamellar keratoplasty had no positive results. There was no significant relationship between the types of transplant procedures and the occurrence of positive microbiologic results (P = 0.08). The overall incidence of clinical infection was found to be 0.4% (2 of 569); however, only 1 case (1 of 569 or 0.2%), which was a Candida albicans infection after Descemet stripping automated endothelial keratoplasty, was attributable to the donor. Of 25 cases in which microbiology studies were not performed, none developed a clinical infection. CONCLUSIONS: Prevalence of positive microbiologic results and subsequent infections do not appear to be increased with the method of donor handling used for newer techniques for keratoplasty.

Comparison of corneal surface higher-order aberrations after endothelial keratoplasty, femtosecond laser-assisted keratoplasty, and conventional penetrating keratoplasty.

PURPOSE: To evaluate and compare corneal higher-order aberrations (HOAs) after Descemet stripping automated endothelial keratoplasty (DSAEK), femtosecond laser-assisted penetrating keratoplasty (FLAK), and conventional penetrating keratoplasty (PKP). METHODS: A retrospective comparison of consecutive surgical series of 67 eyes of 59 patients between 1.5 and 19 months after corneal transplant surgery (22, 34, and 11 corneas underwent DSAEK, FLAK, and PKP, respectively, by a single surgeon). The main outcome measures were anterior and posterior corneal surface HOAs (Zernike polynomials, third to eighth order) determined with Scheimpflug photography at 4.0- and 6.0-mm optical zones and best spectacle-corrected visual acuity (BSCVA) (logarithm of the minimum angle of resolution equivalents). RESULTS: DSAEK had fewer total anterior HOAs compared with FLAK [P = 5.27 × 10(-5) (4.0 mm) and P = 1.02 × 10(-5) (6.0 mm)] and PKP [P = 1.82 × 10(-4) (4.0 mm) and P = 1.56 × 10(-4) (6.0 mm)] but greater total posterior HOAs than FLAK [P = 0.001 (4.0 mm) and P = 0.007 (6.0 mm)] and PKP [at 4.0-mm optical zone (P = 0.047)]. FLAK had fewer total anterior and posterior HOAs than PKP, but differences were not statistically significant. DSAEK grafts exhibited statistically significantly greater posterior HOAs than either type of PKP. The magnitude of anterior and posterior HOAs weakly correlated with BSCVA. CONCLUSIONS: DSAEK induces fewer anterior surface HOAs but greater posterior surface HOAs than FLAK or PKP. Differences between FLAK and PKP are not statistically significant. Anterior and posterior HOAs correlate weakly with poorer visual outcome and likely contribute to decreased BSCVA after keratoplasty.

Femtosecond laser-assisted corneal surgery.

PURPOSE OF REVIEW: A look at the recent advances in corneal transplantation surgery using the femtosecond laser technology. RECENT FINDINGS: The femtosecond laser uses near-infrared light to create photodisruption, a process that allows corneal tissue to be cut at precise depths and in various patterns. Penetrating keratoplasty as well as disease targeted lamellar corneal surgery have been performed using this technology in order to improve surgical outcomes and wound healing. It is now possible to create customized trephination patterns, including 'zig-zag' and 'top-hat', which demonstrate more rapid visual recovery and decreased amounts of astigmatism as compared with conventional blade trephination penetrating keratoplasty. The benefits of these cuts have been extended into the deep anterior lamellar keratoplasty surgery in order to maintain the benefits of the customized cut, whereas preserving the endothelial layer in ectatic and stromal diseases of the cornea. SUMMARY: Femtosecond laser-assisted corneal surgery is improving traditional outcomes in transplantation. Continued studies using this ultrafast laser may continue to yield new and exciting possibilities in the treatment of corneal disease.

Comparison of penetrating keratoplasty performed with a femtosecond laser zig-zag incision versus conventional blade trephination.

PURPOSE: To evaluate visual outcomes and astigmatism in patients who underwent penetrating keratoplasty (PK) with 2 different incision techniques. DESIGN: Retrospective comparison of a consecutive surgical series. PARTICIPANTS: Fifty-seven consecutive patients who underwent PK at the University of California, Irvine, academic referral practice. METHODS: A comparison of 49 eyes of 43 patients that underwent femtosecond laser zig-zag incision pattern PK versus 17 eyes of 14 patients that underwent conventional Barron suction trephination PK performed contemporaneously. All PKs were closed with an identical, 24-bite running nylon suture technique. MAIN OUTCOME MEASURES: Topographically determined astigmatism, best spectacle-corrected visual acuity (BSCVA), and recovery of full visual potential. RESULTS: The postoperative follow-up ranged from 1 to 12 months. There was a significant difference in average astigmatism between the groups at postoperative month 1 (P = 0.013) and 3 (P = 0.018). By month 3, the average astigmatism was 3 diopters (D) in the zig-zag group and 4.46 D in the conventional group. Of the patients with normal macular and optic nerve function (n(ZZ) = 32; n(con) = 14), a significant difference in BSCVA was seen at month 1 (P = 0.0003) and month 3 (P = 0.006) with 81% of the zig-zag group versus 45% of the conventional group achieving BSCVA of > or =20/40 by month 3 (P = 0.03). CONCLUSIONS: The femtosecond laser generated zig-zag-shaped incision results in a more rapid recovery of BSCVA and induces less astigmatism compared with conventional blade trephination PK. FINANCIAL DISCLOSURE(S): Proprietary commercial disclosure may be found after the references.

Patient selection for monovision laser refractive surgery.

PURPOSE OF REVIEW: To investigate the preoperative characteristics and updated patient selection criteria for presbyopic patients undergoing laser refractive surgery for monovision. RECENT FINDINGS: The role of age, sex, ocular dominance, amount of monovision, and hyperopic versus myopic treatments is reviewed and reported. The presbyopic female patient is less likely to reject monovision. Patients with a strong sighting preference do less well due to reduced interocular blur suppression. Although myopes represent the majority of monovision patients, laser-corrected monovision in hyperopes is a viable and satisfactory option. SUMMARY: Refractive surgery monovision correction represents an increasingly popular method for the presbyopic patient. Patient selection based on multiple preoperative characteristics is vitally important to the overall success and patient satisfaction.

Deep anterior lamellar keratoplasty performed with the femtosecond laser zigzag incision for the treatment of stromal corneal pathology and ectatic disease.

We describe a variation of the big-bubble deep anterior lamellar keratoplasty (DALK) technique using the femtosecond laser zigzag incision. This technique allows precise depth visualization for air-needle placement in the posterior stroma based on the lamellar and posterior laser cuts, thus minimizing the risk for perforation of Descemet membrane. The matching donor and host tissue zigzag cut allows more precise tissue apposition and greater surface area for healing. The angled anterior donor and host junction allows a smooth transition for improved visual outcomes. If the big-bubble- Descemet membrane dissection fails, the surgeon can convert to a full-thickness graft while retaining the benefits of the femtosecond laser incision.