Impact of Baseline Quantitative OCT Features on Response to Risuteganib for the Treatment of Dry Age-Related Macular Degeneration: The Importance of Outer Retinal Integrity.

OBJECTIVE: The purpose of the study was to perform a post hoc analysis to explore the effect of baseline anatomic characteristics identified on OCT on best-corrected visual acuity (BCVA) responses to risuteganib from the completed phase II study in subjects with dry age-related macular degeneration (AMD). DESIGN: Post hoc analysis of a randomized, double-masked, placebo-controlled, phase II study. SUBJECTS: Eyes with intermediate dry AMD with BCVA between 20/40 and 20/200. Patients with concurrent vision-influencing or macula-obscuring ocular pathologies were excluded. METHODS: Patients were randomized to receive a 1-mg intravitreal risuteganib injection or a sham injection at baseline. A second 1-mg intravitreal injection of risuteganib was given at week 16 to those in the treatment arm. Two independent, masked reading centers evaluated the baseline anatomic characteristics on OCT to explore features associated with positive responses to risuteganib. MAIN OUTCOME MEASURES: Treatment response was defined as a gain of ≥ 8 letters in BCVA from baseline to week 28 in the treatment arm, compared with baseline to week 12 in the sham group. Anatomic parameters, measured by retinal segmentation platforms, including measures of retinal thickness were compared between the responders and nonresponders to risuteganib. RESULTS: Thirty-nine patients completed the study and underwent analysis. In the treatment arm, 48% of eyes demonstrated treatment responses, compared with 7% in the sham group. In the quantitative anatomic assessment, enhanced ellipsoid integrity, greater outer retinal thickness, and decreased geographic atrophy were associated with increased BCVA gains to risuteganib. CONCLUSIONS: This post hoc analysis demonstrated that baseline OCT features may help determine the likelihood of a functional response to risuteganib. The characterization of higher-order OCT features may provide important information regarding biomarkers for treatment response and could facilitate optimized clinical trial enrollment and enrichment.

Color Vision and Microperimetry Changes in Nonexudative Age-Related Macular Degeneration After Risuteganib Treatment: Exploratory Endpoints in a Multicenter Phase 2a Double-Masked, Randomized, Sham-Controlled, Crossover Clinical Trial.

BACKGROUND AND OBJECTIVE: To explore the association between best-corrected visual acuity (BCVA) improvement and changes in microperimetry (MP) and color vision in patients with nonexudative age-related macular degeneration following administration of two 1.0-mg intravitreal doses of risuteganib. PATIENTS AND METHODS: In a phase 2a, prospective, double-masked, sham-controlled study, eyes with nonexudative age-related macular degeneration and Early Treatment Diabetic Retinopathy Study BCVA between 20/40 and 20/200 were randomized to intravitreal risuteganib (1.0 mg) or sham injection. The risuteganib group received a second 1.0-mg dose, and patients in the sham group crossed over to receive 1.0 mg of risuteganib at week 16. Exploratory endpoints included changes in color vision and mesopic MP. RESULTS: Thirty-nine patients (risuteganib, n = 25; sham, n = 14) completed the study. There was a significant (P < .05) correlation between BCVA and the total error score (TES) for both Lanthony and Hue Style. Confusion index was close to the criterion for significance (P = .056) in the risuteganib group. All color vision metrics demonstrated a trend toward improvement in risuteganib responders (BCVA letter gain ≥8 letters) and no change in the nonresponders, with significant differences seen in confusion index between the risuteganib and control group (P = .0493) and between responders and nonresponders (P = .0478). MP showed that risuteganib responders improved in mean sensitivity and change in number of loci ≤11 dB and ≤0 dB, whereas nonresponders worsened. CONCLUSION: All color vision and MP parameters tested trended toward improvement in risuteganib-treated patients and risuteganib responders. Statistically significant improvement was evident in two metrics: confusion index (in risuteganib-treated patients and responders) and number of loci with decreased sensitivity (in responders). A significant correlation between BCVA and both TES Lanthony and TES Hue Style in risuteganib patients provides concurrent evidence of objective and subjective improvement of retinal function. [Ophthalmic Surg Lasers Imaging Retina 2022;53:430-438.].

Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A Multicenter, Phase 2a, Randomized, Clinical Trial.

BACKGROUND AND OBJECTIVE: To evaluate the safety and efficacy of 1.0 mg risuteganib in subjects with nonexudative age-related macular degeneration (AMD). PATIENTS AND METHODS: This was a phase 2a, prospective, double-masked, sham-controlled study. Eyes with nonexudative (dry) AMD and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 20/40 and 20/200 were included. Subjects were randomized to intravitreal 1.0 mg risuteganib or sham injection. At Week 16, subjects in the risuteganib group received a second 1.0-mg dose and the sham group crossed over to receive a dose of 1.0 mg risuteganib and were evaluated at Week 28. The primary endpoint was proportion of subjects with 8 letters ETDRS or more BCVA gain from baseline to Week 28 in the risuteganib group versus baseline to Week 12 for the sham group. BCVA was tested and subjects were observed for adverse events (AEs) every 4 weeks until completion of the study at 32 weeks. RESULTS: Forty-five subjects (risuteganib, n = 29; sham, n = 16) were enrolled in the study, of whom 39 (risuteganib, n = 25; sham, n = 14) completed the study and were included in the per protocol efficacy analysis. At baseline, mean age was 78.8 and 75.9 years and mean BCVA was 67.1 and 64.4 letters in the sham and risuteganib groups, respectively. The primary endpoint was met by 48% of the risuteganib group at Week 28 and 7% of the sham group at Week 12 (P = .013). Of the risuteganib subjects, 20% gained 15 letters or more at Week 28, whereas no patients in the sham group at Week 12 achieved this visual acuity gain. The only ocular treatment-related treatment-emergent AE was vitreous floaters, which spontaneously recovered without sequelae. No drug-related serious AE was reported. CONCLUSIONS: Risuteganib demonstrated significant BCVA improvement in patients with non-exudative AMD. No drug-related AEs were seen during a 32-week observation period. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:327-335.].

Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery.

PURPOSE: To evaluate femtosecond laser lens fragmentation and anterior capsulotomy in cataract surgery. METHODS: Anterior capsulotomy and phacofragmentation procedures performed with an intraocular femtosecond laser (LenSx Lasers Inc) were initially evaluated in ex vivo porcine eyes. These procedures were then performed in an initial series of nine patients undergoing cataract surgery. In addition to standard intraoperative assessments (including capsulotomy diameter accuracy and reproducibility), optical coherence tomography was used to evaluate human procedures. RESULTS: For an intended 5-mm capsulorrhexis in porcine eyes, average achieved diameters were 5.88+/-0.73 mm using a standard manual technique and 5.02+/-0.04 mm using the femtosecond laser. Scanning electron microscopy revealed equally smooth cut edges of the capsulotomy with the femtosecond laser and manual technique. Compared to control porcine eyes, femtosecond laser phacofragmentation resulted in a 43% reduction in phacoemulsification power and a 51% decrease in phacoemulsification time. In a small series of human clinical procedures, femtosecond laser capsulotomies and phacofragmentation demonstrated similarly high levels of accuracy and effectiveness, with no operative complications. CONCLUSIONS: Initial results with an intraocular femtosecond laser demonstrate higher precision of capsulorrhexis and reduced phacoemulsification power in porcine and human eyes.

Characterization of submicrojoule femtosecond laser corneal tissue dissection.

PURPOSE: To document the acute morphologic features of laser of situ keratomileusis (LASIK) flaps created using an IntraLase femtosecond laser (IntraLase, Inc.) with a 60 kHz engine. SETTING: Laser suite in a clinical practice. METHODS: A LASIK flap was created in 4 human eye-bank eyes using the 60 kHz IntraLase femtosecond laser with the following settings: 110 microm flap thickness, 9.0 mm flap diameter, 60-degree hinge length, 65-degree side cut, 0.4 muJ or 0.7 muJ raster energy, 7 microm x 7 microm or 9 microm x 9 microm spot/line separation, and 1 muJ side-cut energy. Immediately after the laser pass and without the flap being lifted, the globes were placed in fixative and subsequently processed for light and transmission electron microscopy. RESULTS: All 4 procedures were completed without complications or the appearance of an opaque bubble layer. The flaps were of uniform thickness and equaled the attempted thickness. Some areas had a complete dissection; other areas had scattered, incomplete tissue bridges. The adjacent corneal stroma and keratocytes were uninjured. When the epithelium was removed, the stromal component of the flap was measured as the attempted thickness; when the epithelium was present, the total flap thickness approximated the attempted flap thickness. CONCLUSIONS: Laser in situ keratomileusis flaps were safely created using raster energies and laser spot separations below those being used clinically. This technique may allow creation of flaps that are reproducibly thinner than those currently being performed and thus confer the benefits of surface ablation and LASIK.

"Top hat"-shaped penetrating keratoplasty using the femtosecond laser.

PURPOSE: To determine the feasibility of using a modified femtosecond laser to perform penetrating corneal resections. DESIGN: Controlled laboratory study. METHODS: Fourteen corneoscleral rims were mounted on an artificial anterior chamber. Eight underwent traditional penetrating keratoplasty (PKP) and six underwent "top hat"-shaped PKP using a femtosecond laser. Wound leakage pressure and induced astigmatism were compared between the two groups. RESULTS: Deep corneal resection with the femtosecond laser was feasible. Wound leakage occurred at 38 +/- 11 mm Hg in the traditional PKP eyes and at 240 +/- 69 mm Hg in the laser-shaped PKP groups. Initial induced astigmatism was 3.76 +/- 0.82 diopters and 3.46 +/- 1.36 diopters in the traditional and shaped PKP groups, respectively. CONCLUSIONS: Shaped PKP using the femtosecond laser is feasible and provides superior incision integrity compared to traditional PKP. Initial induced astigmatism is dominated by suture effects.

A 60 kHz IntraLase femtosecond laser creates a smoother LASIK stromal bed surface compared to a Zyoptix XP mechanical microkeratome in human donor eyes.

PURPOSE: To compare the stromal surfaces created by the latest mechanical microkeratome and femtosecond, laser technologies. METHODS: Laser in situ keratomileusis (LASIK) flaps were created in six fresh human globes unsuitable for transplantation. The eyes were placed in one of two groups of three globes each. One group had LASIK flaps created with a Zyoptix XP microkeratome using a 120-microm head and a fresh blade for each eye. Another group had flaps created at an attempted 100-microm thickness using the 60 kHz IntraLase femtosecond laser. Immediately following flap creation, the stromal beds were prepared for scanning electron microscopy (SEM). Qualitative roughness of the SEM images was graded by masked observers. Quantitative roughness of the SEM images was assessed using computerized software designed for roughness analysis. Mann-Whitney non-parametric statistical analysis was performed to compare groups. RESULTS: A statistically significant difference was noted in bed smoothness as measured by qualitative roughness and quantitative roughness scores. The IntraLase samples showed smoother stromal beds compared to the Zyoptix group (qualitative roughness = 2.0 +/- 0.7 pm vs 3.6 +/- 1.6 pm, P = .03; quantitative roughness = 20238 +/- 1869 pm vs 26368 +/- 8133 pm, P = .03). CONCLUSIONS: The 60 kHz IntraLase femtosecond laser and the Zyoptix XP 120-microm head using a new blade produced smooth, good quality, compact stromal beds qualitatively and quantitatively. Because the 60 kHz femtosecond laser permits a tight spot/line separation using low energy, it creates a smoother corneal stromal bed compared to previous femtosecond laser engines.

Femtosecond laser keratome creation of partial thickness donor corneal buttons for lamellar keratoplasty.

PURPOSE: To evaluate the thickness and diameter accuracy of the IntraLase femtosecond laser in harvesting corneal discs for lamellar keratoplasty. The stromal bed quality of resected corneas was evaluated by scanning electron microscopy. METHODS: Two IntraLase units were used to create corneal discs at 225-, 300-, 400-, and 500-microm thickness settings and 7-, 8-, 8.5-, and 9-mm diameter settings (n = 28). Achieved thickness was measured using a digital caliper and achieved diameter was measured using imaging software. Samples were preserved and processed for scanning electron microscopy to observe stromal bed quality. RESULTS: On both units, the mean deviation from attempted thickness was -9.5 +/- 8.6 microm (range: +6 to -28 microm). All of the obtained corneal discs were circular (horizontal versus vertical diameters, P > .05). The raster pattern produced a smoother stromal bed compared to the spiral pattern. CONCLUSIONS: The IntraLase femtosecond laser keratome provides depth and diameter accuracy even at increased depth settings. Stromal bed was smooth with the raster pattern and can further be smoothed by excimer phototherapeutic keratectomy treatment. Femtosecond laser lamellar keratoplasty is a promising procedure and clinical data are needed to determine effectiveness.

Comparative study of stromal bed quality by using mechanical, IntraLase femtosecond laser 15- and 30-kHz microkeratomes.

PURPOSE: To evaluate corneal stromal bed quality of lamellar keratectomy in laser in situ keratomileusis (LASIK) procedures by using mechanical and femtosecond laser microkeratomes. METHODS: LASIK corneal flaps were created in 9 fresh human globes not suitable for transplantation. We grouped the samples into 3 different groups of 3 globes each. Group 1 was the control group, in which the flaps were created using a Hansatome microkeratome with a 160-microm head. Groups 2 and 3 consisted of flaps created at the 110-microm flap thickness setting using the IntraLase 15- and 30-kHz femtosecond laser, respectively. All the flaps were removed, and the corneal stromal beds were prepared for scanning electron microscopy (SEM). Qualitative surface roughness (QlSR) of the SEM images was graded using a roughness grading scale from 1 to 5 by 3 masked observers. Quantitative surface roughness (QnSR) of the SEM images was also assessed using software designed for roughness analysis. Mann-Whitney nonparametric statistical analysis was performed to compare groups. RESULTS: There was no statistically significant difference in QlSR and QnSR scores between group 2 and group 1 (brand-new blade only). Group 3 30-kHz IntraLase samples showed a smoother stromal bed compared with group 1 and 2 samples. This was a statistically significant difference for QlSR (QlSR = 1.1 +/- 0.17, P < 0.001) and showed borderline significance for QnSR (QnSR = 24.4 +/- 0.96, P = 0.05). CONCLUSIONS: The IntraLase 15-kHz femtosecond laser 110-microm flaps and the Hansatome 160-microm head using a new blade both produced smooth, good-quality, compact stromal beds as assessed qualitatively by masked observers and quantitatively by image analysis software. The 30-kHz femotsecond laser permits a tighter spot/line separation and lower energy per pulse, which creates smoother corneal stromal beds.

Top hat wound configuration for penetrating keratoplasty using the femtosecond laser: a laboratory model.

PURPOSE: To evaluate the mechanical stability and induced astigmatism of a modified multiplanar "top hat" wound configuration for full-thickness penetrating keratoplasty (PK) using the femtosecond laser as compared with PK in a laboratory model. METHODS: Eight human corneoscleral rims were mounted on an artificial anterior chamber. Four samples were assigned to the traditional PK group. Four samples underwent full-thickness keratoplasty with the femtosecond laser: a 9.0-mm cylindrical cut was made from the anterior chamber into the stroma, followed by a ring-shaped (outer diameter 9.0 mm, inner diameter 7.0 mm) horizontal lamellar resection at two-thirds corneal depth and a 7.0-mm cylindrical cut from the lamellae to the corneal surface. Mechanical stability was evaluated after placement of the cardinal sutures and the running sutures. RESULTS: In the "top hat" PK group, wound leakage occurred at 19 +/- 3.36 mm Hg after placement of the cardinal sutures and at 86.25 +/- 9.74 mm Hg after placement of the running sutures. In the traditional PK group, leakage occurred at 0 +/- 0 mm Hg and 76.25 +/- 20.98 mm Hg after placement of the cardinal sutures and running sutures, respectively. Both techniques induced steepening of the corneal curvature postop. The modified wound group showed a mean change in average K of 3.43 +/- 3.62 D, whereas the traditional PK group showed a mean change in average K of 3.21 +/- 6.67 D. CONCLUSION: The femtosecond laser-produced "top hat" wound configuration for PK was found to be more mechanically stable than that produced by the traditional method.

Ingress of India ink into the anterior chamber through sutureless clear corneal cataract wounds.

BACKGROUND: Sutureless clear corneal cataract incisions may be associated with an increased risk of endophthalmitis. OBJECTIVE: To assess the degree of ocular surface fluid ingress into the anterior chamber of cadaveric human globes with clear corneal wounds. METHODS: Self-sealing clear corneal incisions were created in 4 eyes, and intraocular pressure was controlled with an infusion cannula. To evaluate possible flow of surface fluid through the corneal wound, india ink was applied to the corneal surface while the intraocular pressure was varied, so as to simulate the intraocular pressure fluctuations secondary to blinking or eye squeezing. The optical density from aqueous samples of globes were measured both before and after india ink application using a spectrophotometer. RESULTS: Aqueous aspirates from the 3 globes with sutureless clear corneal wounds revealed a significant increase in spectrophotometric readings (P<.01), in contrast to the sutured wound, which did not show an increase in absorbance level relative to the baseline. Ink particles were both grossly and microscopically visible inside the sutureless corneal wounds. CONCLUSIONS: Fluctuations of intraocular pressure following sutureless clear corneal cataract surgery may allow entry of surface fluid into the anterior chamber during the initial postoperative period when the wound is not healed.

A technique to harvest Descemet's membrane with viable endothelial cells for selective transplantation.

PURPOSE: To describe a surgical technique using an artificial anterior chamber to facilitate harvest of Descemet's membrane (DM) and endothelium for corneal endothelial cell transplantation. DESIGN: Laboratory investigation. METHODS: Corneoscleral buttons of seven human donor eyes were mounted endothelial side up on an artificial anterior chamber. Keeping the endothelial side with its usual concavity, a manual trephination was made on the posterior surface with a 9.0-mm trephine, inside the Schwalbe line and just past the DM in depth. The chamber was filled with air, causing the endothelial side of the donor cornea to assume a convex configuration. The DM along with its endothelium was separated from the posterior stroma using a blunt cyclodialysis spatula. Drops of trypan blue 0.3% and alizarin red S 0.2% (n = 6) were applied. The stained DMs were examined under a light microscope and photographed to calculate the percentage of endothelial cell damage. Histology was done on the unstained cornea. RESULTS: The DM carrying endothelium was successfully removed from the posterior stroma in all seven eyes. Although the DM appears to be very friable, all samples were removed in toto without rupture. Vital staining showed a mean endothelial cell loss of 8.46% (standard deviation (SD) 6.9). Direct light microscopy demonstrated the preservation of endothelial cell morphology. CONCLUSIONS: This technique appears to be a safe and straightforward method to harvest DM for endothelial cell transplantation. Further studies are underway to determine the optimal method of insertion of the obtained healthy DM with endothelial cells through small corneal incisions.

Randomized prospective clinical study comparing induced aberrations with IntraLase and Hansatome flap creation in fellow eyes: potential impact on wavefront-guided laser in situ keratomileusis.

PURPOSE: To measure and compare the changes in objective wavefront aberration and subjective manifest refraction after laser in situ keratomileusis (LASIK) flap creation with a mechanical microkeratome and a femtosecond laser. SETTING: Private practice refractive surgery center, Irvine, California, USA. METHODS: This randomized prospective study comprised 9 patients (18 eyes) treated with a 2-step LASIK procedure: lamellar keratectomy with a Hansatome microkeratome (Bausch & Lomb) or the IntraLase femtosecond laser in fellow eyes followed by non-wavefront-guided (standard) excimer laser treatment with the Technolas 217A (Bausch & Lomb) excimer laser 10 weeks later. Fellow eyes were matched to within 0.75 diopter (D) sphere and 0.50 D cylinder. Patients were followed for 3 months after excimer laser treatment. Preoperative and post-flap creation wavefront aberrometry using a Hartmann-Shack aberrometer and manifest refraction were compared between the 2 groups. The same tests were performed 3 months after excimer laser ablation. RESULTS: Statistically significant changes were seen in defocus wavefront aberrations after Hansatome (P=.004) and IntraLase (P=.008) flap creation. A hyperopic shift in manifest refraction was noted in the Hansatome group after the creation of the corneal flap (P=.04); no statistically significant changes in manifest refraction were seen in the IntraLase group. Statistically significant changes in total higher-order aberrations (HOAs) (trefoil and quadrafoil Zernike terms) were seen after flap creation in the Hansatome group (P=.02). No significant changes in HOAs were noted after flap creation in the IntraLase group. After the flap was relifted and standard excimer laser ablation was performed, a statistically significant increase in coma occurred in the Hansatome group (P=.008). Standard refractive outcomes in the 2 groups were similar. CONCLUSIONS: The creation of the LASIK flap alone can modify the eye's optical characteristics in low-order aberrations and HOAs. A significant increase in HOAs was seen in the Hansatome group but not in the IntraLase group. This may have significant clinical implications in wavefront-guided LASIK treatments, which are based on measurements made before flap creation.

Fluoroquinolone therapy in Mycobacterium chelonae keratitis after lamellar keratectomy.

PURPOSE: To characterize a rabbit model of Mycobacterium chelonae keratitis after lamellar keratectomy and assess the effectiveness of fluoroquinolone therapy. SETTING: University Laboratory, University of California, Irvine, California, USA. METHODS: Twenty-eight New Zealand white rabbits had unilateral lamellar keratectomy with placement of 2.5 x 10(5) colony-forming units of log-phase M chelonae under each flap. Eyes (7 per group) were randomized and treated with sterile balanced salt solution, gatifloxacin 0.3%, ciprofloxacin 0.3%, or levofloxacin 0.5% 4 times daily. Two masked observers examined all eyes on days 2, 5, and 7 and weekly for 4 weeks. Severity of disease and bacterial culture results were the main outcomes measured. The means and standard deviations were calculated, and differences between the groups were statistically analyzed. RESULTS: All eyes developed clinical disease. At the time the rabbits were killed, eyes treated with balanced salt solution, ciprofloxacin, levofloxacin, and gatifloxacin were culture positive in 6 (85.7%), 7 (100%), 6 (85.7%), and 3 (42.9%) of 7 eyes per group, respectively. Frequency of positive culture and the severity of clinical disease in gatifloxacin-treated eyes were significantly less (P < .05) than in the other groups combined. CONCLUSIONS: The rabbit model of M chelonae keratitis was successfully developed in our study. A fourth-generation quinolone (gatifloxacin) showed the best performance among the fluoroquinolones tested in our experimental approach. The fourth-generation fluoroquinolone, gatifloxacin, could be effectively used for the treatment of mycobacterial keratitis.

Femtosecond laser posterior lamellar keratoplasty: a laboratory model.

PURPOSE: To evaluate feasibility of femtosecond laser application in posterior lamellar keratoplasty. METHODS: To evaluate the laser's effectiveness through opaque corneas, anterior corneal caps were resected from opaque corneas induced with 80% acetone solution. To evaluate the femtosecond laser posterior lamellar keratoplasty surgical procedure, human corneoscleral rims were mounted on an artificial anterior chamber. After corneal pachymetry, the femtosecond laser was used to create a 6-mm-diameter, 200-microm-thick endostromal lenticule. Access to the lenticule was provided by a small perilimbal surface opening, also created by the laser. The lenticule was removed using a pair of corneal forceps. A donor lenticule of similar dimensions was created, its endothelial surface coated with viscoelastic, inserted, and positioned on the recipient bed. Two sutures were placed to seal the small surface opening. RESULTS: The femtosecond laser produced an effective and smooth dissection through opaque corneas even at deeper settings. Graft transplantation was fairly simple and effective. CONCLUSION: Femtosecond laser posterior lamellar keratoplasty is a procedure that may provide an alternative to penetrating keratoplasty or the technically challenging manual posterior lamellar keratoplasty.

Femtosecond laser-assisted intracorneal keratoprosthesis implantation: a laboratory model.

PURPOSE: To demonstrate femtosecond laser-assisted intracorneal keratoprosthesis implantation and determine the mechanical stability as a function of intraocular pressure. METHODS: Eight human corneoscleral rims were mounted on an artificial anterior chamber. The femtosecond laser microkeratome was used to create a 2.5-mm diameter posterior corneal cap. A 7.2-mm-diameter lamellar stromal pocket was then created at mid-corneal depth. Finally, a 6-mm arc opening to the corneal surface was created at the periphery of the lamellar cut. The posterior lenticule was removed using corneal forceps and a 7.0-mm biopolymer keratoprosthesis was inserted into the stromal pocket. The surface wound was sealed using two 10-0 nylon sutures. A 3.0-mm anterior corneal opening was trephined to expose the keratoprosthesis. Intrachamber pressure was raised until wound leak was observed. RESULTS: Seven of the 8 implants withstood pressures of at least 135 mm Hg without implant extrusion. CONCLUSION: Femtosecond laser corneal dissection provides an alternative to more challenging manual dissection methods for keratoprosthesis implantation. Use of the femtosecond laser microkeratome will further refine keratoprosthesis surgical technique and may allow rapid and easy execution of the surgery.

Inflow of ocular surface fluid through clear corneal cataract incisions: a laboratory model.

PURPOSE: To evaluate the self-sealing properties of standard clear corneal cataract incisions during two events: (1) application of mechanical external pressure, or (2) controlled fluctuation of intraocular pressure (IOP). DESIGN: Laboratory investigation. METHODS: Eight fresh human donor globes were prepared for Miyake video microscopy. A standard two-plane 3-mm clear corneal incision was created and a 3 x 3-mm sponge soaked with India ink was placed on the wound surface. One globe with a sutured corneal wound served as the control. A transcleral cannula was inserted and connected to a bottle of saline. Intraocular pressure was modified varying the bottle height. External pressure was applied through manual contact on different regions of cornea. RESULTS: Four of seven eyes demonstrated intraocular presence of ink, three of them after external manipulation and another after varying the IOP. CONCLUSION: Self-sealing properties of unsutured clear corneal wounds were compromised in our model. These data may give insight into the possible mechanisms involved in the inflow of extraocular fluid into the eye through clear corneal cataract incisions.

Fluoroquinolone therapy in multiple-drug resistant staphylococcal keratitis after lamellar keratectomy in a rabbit model.

PURPOSE: To assess the effectiveness of a fourth-generation fluoroquinolone for prophylaxis against multiple drug-resistant staphylococcal keratitis after lamellar keratectomy in a rabbit model. DESIGN: Experimental study. METHODS: Twenty-eight New Zealand white rabbits underwent unilateral lamellar keratectomy using a manual microkeratome followed by the placement of 1000 colony-forming units (CFUs) of log-phase Staphylococcus aureus bacteria under each flap. Eyes (seven in each group) were randomized and treated with one of the following agents: sterile balanced salt solution, gatifloxacin (0.3%), ciprofloxacin (0.3%) or levofloxacin (0.5%) immediately and 6, 12, and 18 hours after surgery. Inflammation was graded by two masked observers at 24 and 48 hours, and the presence or absence of infectious infiltrates was determined. The means and standard deviations were calculated, and differences among the groups were statistically analyzed. RESULTS: There were no flap complications encountered during surgery. Eyes treated with ciprofloxacin, levofloxacin, and balanced salt solution developed infectious infiltrates in five of seven eyes per group. Gatifloxacin-treated eyes did not develop clinical infection and exhibited lower mean inflammation scores (P <.01 compared with the other groups). CONCLUSION: The fourth-generation fluoroquinolone, gatifloxacin, is an effective prophylaxis against the development of keratitis after lamellar keratectomy in rabbits with an organism resistant to methicillin, levofloxacin, and ciprofloxacin.

A portable microkeratome for harvesting the human anterior corneal surface.

A portable, gas-driven turbine microkeratome device capable of harvesting the entire anterior corneal surface for lamellar transplantation on human donor globes was evaluated. The device consisted of a modified LASIK microkeratome with an enlarged suction ring, head, and blade. Vacuum was achieved by a simple hand pump. Lamellar keratectomy was performed on 5 fresh human donor globes. Lenticule dimensions were measured on days 0, 3, 6, and 9 after storage in preservation media at 4 degrees C. On day 0, the obtained lenticules were 13.9 +/- 0.9 mm and 13.5 +/- 0.4 mm, vertical and horizontal diameters, respectively. The average central lenticule thickness was 152.2 +/- 52 microm. Each lenticule was uniform in thickness over 5 measurement points (P = 0.74). Repeat measurements of corneal thickness over the 9 days showed no statistically significant difference (P = 0.51). On day 9 lenticules were 14.6 +/- 0.3 mm and 14.6 +/- 0.4 mm, vertical and horizontal diameters, respectively. When day 0 was compared to day 9, vertical diameter also showed no statistically significant difference (P = 0.16), whereas horizontal diameter was significantly different (P < 0.001). This device proves to be an economical alternative to electric-powered systems for the harvest of transplantable corneal sections.

A portable microkeratome-based anterior corneal surface harvesting device.

PURPOSE: To determine the reproducibility of anterior sclerokeratectomy using a portable nonelectric microkeratome-based device capable of harvesting the entire anterior corneal surface for lamellar transplantation. METHODS: A modified gas turbine-driven microkeratome (LSK One, Moria/Microtech, Doylestown, PA) with a redesigned head large enough to incorporate the whole human anterior corneal surface in a pass and was coupled to a manual vacuum pump. This instrument was tested on 25 fresh porcine globes divided into 2 groups (170-microm and 200-microm head). To assess cut reproducibility the physical dimensions (diameter and thickness) of the obtained lenticules were measured. RESULTS: The obtained lenticules were fairly circular (horizontal versus vertical diameters, p >0.2), with average diameters of 12.85 +/- 0.52 mm and 13.25 +/- 1.15 mm for the 170 and 200-microm heads, respectively. The average central lenticule thickness was 176.92 +/- 34.68 microm and 166.00 +/- 53.74 microm for the 170 and 200-microm heads, respectively. CONCLUSION: This new system presents an economical and portable alternative to electric-powered systems. In addition to being used by surgeons in the operating room, eye bank technicians in the field could theoretically use this system; including in developing countries where cost, availability of electricity, and portability are issues.