Visual and Refractive Outcomes After Bilateral Implantation of a Biconvex Aspheric Toric Monofocal Intraocular with a Double C-Loop Haptic Design.

Purpose: To show the visual and refractive outcomes in cataract patients with corneal astigmatism when bilaterally implanted with a biconvex aspheric toric monofocal intraocular lens (IOL) with a double C-loop haptic-design. Methods: Forty-seven cataract patients (94 eyes) with corneal astigmatism (≥0.75D) were implanted with the monofocal PODEYE toric IOL and assessed for 4-6 months post-surgery. Measurements included monocular and binocular uncorrected-distance visual acuity (UDVA) and corrected-distance visual acuity (CDVA), under both photopic and mesopic lighting conditions. Refraction, photopic and mesopic contrast sensitivity (with and without glare), and rotational stability were also recorded at the last postoperative visit. Results: At 4-6 months, 78.2% and 98.9% of eyes were within ±0.50D and ±1.00D of the target refraction, respectively. The mean spherical equivalent and refractive cylinder values were 0.09±0.35D and -0.36±0.35D, respectively. 76.5% and 98.8% of eyes presented a postoperative refractive cylinder of ≤0.50D and ≤1.00D, respectively. 91.5% and 100% of patients had a binocular UDVA and CDVA of ≥20/25, respectively. The mean binocular UDVA and CDVA were 0.02±0.08 and -0.02±0.07 logMAR, respectively. Under mesopic conditions, 78.7% and 83.0% of patients presented a binocular UDVA and CDVA ≥20/32, respectively. The mean binocular UDVA and CDVA were 0.15±0.11 and 0.12±0.11 logMAR, respectively. The patients showed good contrast sensitivity under photopic and mesopic conditions. The mean absolute IOL rotation was 1.22±2.21 degrees with 97.87% of eyes having a rotation of <10 degrees. Conclusion: This study shows good visual and refractive outcomes for the PODEYE toric IOL when implanted bilaterally in cataract patients with corneal astigmatism.

Comparison of 3-month visual outcomes of a new multifocal intraocular lens vs a trifocal intraocular lens.

PURPOSE: To compare the clinical performance of the TECNIS Synergy multifocal (model ZFR00V) intraocular lens (IOL) with that of the AcrySof PanOptix Trifocal (model TFNT00) IOL in patients undergoing bilateral cataract surgery. SETTING: Multicenter clinical setting. DESIGN: Prospective randomized comparative study. METHODS: Patients aged 22 years or older were randomly assigned (2:1) to bilateral implantation with ZFR00V or TFNT00 IOLs. End points included the mean binocular distance-corrected near visual acuity (DCNVA) at 40 cm, photopic and mesopic DCNVAs at 33 cm, photopic low-contrast corrected distance visual acuity (CDVA) and mesopic CDVA, nondirected patient responses to an ocular/visual symptoms questionnaire, and safety. RESULTS: Of the 150 patients implanted with IOLs, 95 of the 97 patients with ZFR00V IOLs and 52 of the 53 patients with TFNT00 IOLs completed the 3-month follow-up. Most patients in the ZFR00V and TFNT00 groups achieved 20/25 or better binocular CDVA (100% vs 96.2%) and DCNVA measured at 40 cm (88.4% vs 75.0%) and 33 cm (78.9% vs 51.9%). The mean between-group difference in binocular DCNVA at 40 cm favored ZFR00V IOLs (0.5 lines Snellen; 95% CI, 0.012 to 0.089; P ≤ .05). Similarly, the mean binocular photopic and mesopic DCNVAs at 33 cm (0.8 lines Snellen each; both P ≤ .05 vs TFNT00) and photopic high-contrast and low-contrast CDVA (0.5 lines Snellen each; both P ≤ .05 vs TFNT00) favored ZFR00V IOLs. Patient-reported ocular/visual symptoms and safety were generally similar between the 2 IOLs. CONCLUSIONS: The ZFR00V IOL showed an extensive range of vision, particularly through near distances, and better mesopic performance than the TFNT00 IOL in patients undergoing cataract surgery.

Toric phakic IOLs in keratoconus-evaluation of preoperative parameters on the outcome of phakic anterior chamber lens implantation in patients with keratoconus.

PURPOSE: To evaluate the influence of the type of the keratectasia and preoperative keratometry readings on the efficacy of implantation of iris-fixated phakic anterior chamber intraocular lenses (pIOL) in patients with keratoconus. METHODS: In this retrospective study, iris-fixated pIOLs (Artisan/Artiflex (Ophtec®), Verisyse/Veriflex (AMO®)) were implanted in 38 eyes of 22 patients with stable keratoconus. Thirty-six eyes underwent corneal crosslinking (CXL) prior to the lens implantation. The refractive outcome was evaluated 6 weeks postoperatively and the influence of preoperative refraction and topo- and tomographical factors were analyzed. RESULTS: The mean postoperative uncorrected distance visual acuity (UDVApost) was 0.25 ± 0.15 logMAR and was not statistically different from the mean preoperative corrected distance visual acuity (CDVApre), which was 0.24 ± 0.13 logMAR. Twenty-seven eyes (71%) reached UDVApost/CDVApre ≥ 1 (efficacy index), whereas patients with PMD-like ectasia (n = 14) showed significantly (p = 0.003) higher efficacy index (100%) than patients diagnosed with keratoconus (n = 24) (54%). Higher eccentricity of the maximum posterior elevation showed a significant beneficial influence on the efficacy index (p = 0.021). Furthermore, a higher Amsler-Krumeich stage and preoperative MAE were correlated with a worse UDVApost. The mean absolute spherical equivalent was significantly decreased from 5.71 ± 4.96 D to 1.25 ± 1.20 D (p < 0.001). No significant difference was found in endothelial cell count. CONCLUSION: The results indicate that the implantation of phakic iris-fixated anterior chamber IOLs is a reasonable refractive option for patients with keratoconus. Keratoconus patients with a pellucidal marginal degeneration (PMD)-like appearance ectasia seem to benefit most from such procedures.

Localized calcification of hydrophilic acrylic intraocular lenses after posterior segment procedures.

PURPOSE: To describe the clinical and laboratory findings in a series of cases of hydrophilic acrylic intraocular lens (IOL) opacification after posterior segment procedures. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, USA. DESIGN: Experimental study. METHODS: Thirty hydrophilic acrylic IOLs were explanted after various posterior segment procedures (pars plana vitrectomy, intravitreal anti-vascular endothelial growth factor injections) because of localized central anterior surface and subsurface optic opacification associated with decreased visual function. Once received by the laboratory in the dry state or in fixative by the explanting surgeons, microscopic, histochemical (alizarin red), and surface analysis (scanning electron microscopy [SEM], energy-dispersive X-ray spectroscopy [EDS]) evaluations were performed on the IOLs. The surgeons were sent a questionnaire to obtain information pertinent to each case. RESULTS: Of the 30 explanted IOLs, 9 hydrophilic acrylic designs from 7 different manufacturers were identified. Gross microscopy and light microscopy showed granular deposits in a dense round pattern of distribution within the margins of the capsulorhexis or pupil on the anterior surface/subsurface of the IOLs. The granules stained positive for calcium with alizarin red. On SEM coupled with EDS, the granular deposits were found to comprise calcium and phosphate. CONCLUSIONS: A localized pattern of anterior surface/subsurface calcification was seen on hydrophilic acrylic IOLs from various manufacturers. The calcification resembled the pattern seen on calcified IOLs after anterior segment procedures using intracameral injections of air or gas. This calcification of hydrophilic acrylic IOLs is likely the result of blood-aqueous barrier breakdown from repeated intraocular procedures.

Calzone-Like Traumatic Flap Dislocation Four Years after Laser in situ Keratomileusis.

A 46-year-old patient presented with a flip-folded partially dislocated flap after trauma caused by a sheet of paper, four years after a reportedly uneventful laser in situ keratomileusis procedure using microkeratome. Flap re-lift, mechanical debridement, and flap stretching were performed in a first interventional approach. Due to epithelial ingrowth two month after the first intervention, a flap re-lift and mechanical removal of epithelial cells from the stroma bed and flap were performed. In addition, triamcinolone was applied subconjunctivally. Thereafter, best corrected visual acuity of 20/20 was regained and no more epithelial ingrowth was observed. Only few cases of flap dislocation with epithelial ingrowth have been described in the literature following trauma, though none of a permanently inward folded flap. The use of subconjunctival triamcinolone is a new approach to prevent recurrent epithelial ingrowth.

Five-Year, Prospective, Randomized, Multi-Surgeon Trial of Two Trabecular Bypass Stents versus Prostaglandin for Newly Diagnosed Open-Angle Glaucoma.

PURPOSE: To evaluate 5-year safety and efficacy of 2 trabecular micro-bypass stents versus prostaglandin as initial stand-alone treatment for newly diagnosed, treatment-naive primary open-angle glaucoma (POAG). DESIGN: Prospective, randomized, controlled, multi-surgeon clinical trial. PARTICIPANTS: Enrolled eyes (n = 101) were phakic and had a confirmed POAG diagnosis, normal angle anatomy, mean diurnal intraocular pressure (IOP) 21 to 40 mmHg, and vertical cup-to-disc (C:D) ratio ≤0.9. METHODS: Eyes were randomized (1:1) to receive either 2 stents (iStent trabecular micro-bypass; Glaukos Corporation, San Clemente, CA) or once-daily topical travoprost. MAIN OUTCOME MEASURES: The primary and secondary efficacy end points were the change from screening in mean diurnal IOP at months 12 and 24, respectively, without glaucoma surgery or add-on medication (any medication in stent eyes or a second medication in travoprost eyes). Two additional secondary end points were the proportion of eyes achieving treatment success at months 12 and 24, defined as IOP 6 to 18 mmHg without additional medication or glaucoma surgery. This report shows these efficacy measures through 60 months. Safety measures included best-corrected visual acuity, C:D ratio, visual field, pachymetry, complications, and adverse events. RESULTS: Of 101 enrolled eyes (54 stent eyes, 47 travoprost eyes), 90 eyes (49 stent eyes, 41 travoprost eyes) completed 5-year follow-up. Five-year mean diurnal IOP was 16.5±1.2 mmHg in stent eyes (35.3% reduced vs. 25.5±2.5 mmHg preoperatively; P < 0.0001) and 16.3±1.9 mmHg in travoprost eyes (35.1% reduced vs. 25.1±4.6 mmHg preoperatively; P < 0.0001). During follow-up, add-on medication was initiated in 12 stent eyes (22.2% of the initial 54-eyes) and 18 travoprost eyes (38.3% of the initial 47-eyes). By 5 years, 17% (6/35) of stent eyes and 44% (14/32) of travoprost eyes needed add-on medication to control IOP (P = 0.017). Treatment success was achieved in 77% (27/35) of stent eyes and 53% (17/32) of travoprost eyes (P = 0.04). Both groups exhibited excellent safety. CONCLUSIONS: This prospective randomized trial demonstrates 5-year effectiveness and safety of 2 trabecular bypass stents in patients with newly diagnosed, treatment-naive POAG, with comparably favorable outcomes as topical prostaglandin.

Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months.

PURPOSE: To examine outcomes through 36 months in phakic eyes with newly diagnosed primary open-angle glaucoma (POAG) naïve to therapy randomized to treatment with two trabecular micro-bypass stents or topical prostaglandin. METHODS: Subjects with POAG naïve to therapy, with intraocular pressure (IOP) ≥21 and ≤40 mmHg, were randomized to implantation of two stents or travoprost. Additional medication was to be prescribed post-treatment for elevated IOP or glaucomatous optic nerve findings. Of 101 randomized subjects, 100 subjects were followed for 24 months and 73 subjects were followed for 36 months. Follow-up on all subjects is ongoing. RESULTS: In this randomized cohort of 101 POAG subjects, 54 subjects underwent 2-stent surgery and 47 received topical travoprost. Mean pre-treatment IOP was 25.5 ± 2.5 mmHg in stent-treated eyes and 25.1 ± 4.6 mmHg in medication-treated eyes. By 3 years, mean IOP was 14.6 mmHg in stent eyes (with medication added in 6 eyes) and 15.3 mmHg in travoprost eyes (with a second medication added in 11 eyes). In the subset of eyes that did not require additional medical therapy, mean IOP was 14.5 mmHg and 15.7 mmHg in the respective groups. Ninety-one percent of stent eyes had 3-year IOP ≤18 mmHg without additional therapy (62% ≤ 15 mmHg) and 79% of travoprost eyes had 3-year IOP ≤18 mmHg (21% ≤ 15 mmHg). Safety was favorable in both groups. CONCLUSIONS: In this prospective, randomized comparison of subjects with newly diagnosed POAG naïve to therapy, substantial IOP reduction with a favorable low complication rate was shown through 3 years after either 2 trabecular stents implanted as the sole procedure or topical travoprost therapy. These data suggest 2-stent implantation may be a viable initial treatment option comparable to topical prostaglandin in newly diagnosed POAG patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01443988. FUNDING: Glaukos Corporation, Laguna Hills, CA.

Anterior haptic flexing and in-the-bag subluxation of an accommodating intraocular lens due to excessive capsular bag contraction.

UNLABELLED: We describe the case of a patient who had cataract surgery with implantation of the hydrophilic acrylic Tetraflex accommodating intraocular lens (IOL), with subsequent development of capsulorhexis phimosis and in-the-bag IOL subluxation. Contraction of the capsular bag secondary to fibrosis resulted in significant anterior flexing of the lens haptic component. Explantation of the IOL-capsular bag complex was required 7 years after implantation. Histopathologic analysis demonstrated multiple areas of thick anterior subcapsular fibrosis. Pseudoexfoliative material was present throughout the surface of the lens capsule. Intraocular lenses manufactured from hydrophilic acrylic material are highly flexible and may be more susceptible to capsule contraction, even in the absence of predisposing ocular and systemic conditions. This case highlights the importance of developing guidelines regarding patient screening and selection for the appropriate use of accommodating and other highly flexible IOLs. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

New Hydrophobic IOL Materials and Understanding the Science of Glistenings.

An introduction to the history of intraocular lenses (IOLs) is given, leading up to modern hydrophobic examples. The roles of hydrophobicity, hygroscopy, materials chemistry, and edge design are discussed in the context of IOLs. The four major types of IOL materials are compared in terms of their chemistry and biocompatibility. An example of a modern "hydrophobic" acrylic polymer with higher water content is discussed in detail.

Phacoemulsification and intraocular lens implantation before, during, or after canaloplasty in eyes with open-angle glaucoma: 3-year results.

PURPOSE: To report 3-year results evaluating the effect on safety and efficacy of canaloplasty to treat open-angle glaucoma when combined with cataract surgery. PATIENTS AND METHODS: This was a retrospective subset analysis of a prospective, international, multicenter study evaluating 133 eyes of 133 adult, open-angle glaucoma patients who underwent canaloplasty with tensioning suture placement. Eighty-two phakic eyes that received canaloplasty alone were compared with 51 eyes that underwent cataract surgery before or during canaloplasty. RESULTS: Phakic eyes that received combined cataract-canaloplasty surgery (phacocanaloplasty) had a mean±SD baseline IOP of 23.5±5.2 mm Hg and mean glaucoma medication usage of 1.5±1.0 decreasing to a mean IOP of 13.6±3.6 mm Hg on 0.3±0.5 medications at 3 years postoperatively. Pseudophakic eyes undergoing canaloplasty had a mean baseline IOP of 23.9±5.2 mm Hg on a mean of 1.8±0.8 glaucoma medications decreasing to 15.6±3.5 mm Hg on 1.1±0.8 medications at 3 years. In phakic eyes, reductions in IOP were significantly greater and less postoperative IOP lowering medication was needed after undergoing phacocanaloplasty compared to eyes which had canaloplasty alone. CONCLUSIONS: Clear corneal phacoemulsification performed before or in combination with canaloplasty is a safe and effective surgical procedure to reduce IOP in adult patients with open-angle glaucoma.

Safety of submacular suprachoroidal drug administration via a microcatheter: retrospective analysis of European treatment results.

PURPOSE: To investigate the safety and feasibility of using a microcatheter for drug delivery in the suprachoroidal space in eyes with advanced, exudative, age-related macular degeneration (AMD) unresponsive to conventional therapy. PROCEDURES: A unique microcatheter was used to deliver a drug combination consisting of bevacizumab and triamcinolone to the submacular suprachoroidal space. Twenty-one eyes of 21 patients with choroidal neovascularization (CNV) secondary to advanced, exudative AMD were followed over a 6-month postprocedure period. RESULTS: The microcatheter was successfully and atraumatically inserted into the suprachoroidal space of all eyes. No serious intraoperative or postoperative complications including suprachoroidal hemorrhages were encountered. Postsurgically, complications consisted of 1 eye experiencing a transient elevation in intraocular pressure at 3 months, which was medically controlled, and 2 eyes (10.5%) with an apparent increase in nuclear sclerotic cataracts. CONCLUSIONS: Suprachoroidal drug administration was achieved without serious complication using a novel microcatheter. Direct drug delivery to the choroid can potentially increase local tissue drug levels and drug efficacy for the treatment of AMD and other diseases associated with CNV.

In-the-bag capsular tension ring and intraocular lens subluxation or dislocation: a series of 23 cases.

OBJECTIVE: To describe clinical and pathologic findings from cases of in-the-bag capsular tension ring (CTR) and intraocular lens (IOL) subluxation or dislocation. DESIGN: Retrospective case series with clinicopathologic correlation. PARTICIPANTS: Twenty-three explanted subluxated/dislocated capsular bags containing a CTR and an IOL explanted in Europe and submitted in fixative to the Berlin Eye Research Institute. METHODS: Standard gross and light microscopy of specimens, complete histopathologic analyses of selected specimens done at the University of Utah, as well as questionnaire sent to explanting surgeons, and patient chart review, when available. MAIN OUTCOME MEASURES: Lens design, material, and abnormalities, capsular bag anomalies, patient demographic data, surgical dates, and presence or absence of known risk factors. RESULTS: Patients were aged 76.31 ± 8.24 years at explantation, which was performed 81.5 ± 32.2 months after implantation. The IOLs in these cases were 3-piece hydrophobic acrylic (N = 11), 1-piece hydrophobic acrylic (n = 6), 3-piece silicone (n = 4), or 1-piece hydrophilic acrylic (n = 2) designs; all CTRs were made of poly(methyl methacrylate). Available information on associated ocular conditions included pseudoexfoliation (n = 17), glaucoma (n = 4), vitrectomy/retina surgery (n = 3), and trauma (n = 1). Complete histopathologic assessment in 3 specimens showed signs consistent with pseudoexfoliation, without available history related to this condition in one of the cases. Moderate/severe degrees of Soemmering's ring formation and capsulorhexis phimosis were observed or reported in 13 and 11 specimens, respectively. Fourteen eyes were implanted and explanted by the same surgeon, with an interval of 92.7 ± 23.4 months between the procedures. His rate of explantation because of subluxation/dislocation was 0.76% of the CTRs implanted during the time considered. CONCLUSIONS: Explantation because of postoperative subluxation or dislocation of CTR-IOL-capsular bag complexes occurred approximately 6.8 years after implantation in this series, providing further evidence that a fine line exists between zonular insufficiency that can be stabilized with the CTR alone and that requiring further support. Analyses of large series may help to define common factors associated with this complication, as well as surgical planning and employment of various endocapsular support devices to enhance postoperative zonular stabilization.

Three-year canaloplasty outcomes for the treatment of open-angle glaucoma: European study results.

BACKGROUND: To report 3-year results investigating the safety and efficacy of canaloplasty, a procedure involving circumferential viscodilation of Schlemm's canal and tensioning of the inner canal wall to treat open-angle glaucoma. METHODS: This was a prospective, multi-center, interventional study of 109 eyes of 109 adult, open-angle glaucoma patients undergoing canaloplasty or combined cataract-canaloplasty surgery. Qualifying preoperative intraocular pressures (IOP) were at least 16 mmHg with historical IOPs of at least 21 mmHg with or without medical therapy. A flexible microcatheter was used to viscodilate the full circumference of the canal and to place a trabecular tensioning suture. Primary outcome measures included IOP, glaucoma medication usage, and adverse events. RESULTS: Eyes with canaloplasty showed a mean baseline IOP of 23.0 ± 4.3 mmHg and mean glaucoma medication usage of 1.9 ± 0.7 medications, which decreased to a mean IOP of 15.1 ± 3.1 mmHg on 0.9 ± 0.9 medications at 3 years postoperatively. Eyes with combined cataract-canaloplasty surgery showed a mean baseline IOP of 24.3 ± 6.0 mmHg on 1.5 ± 1.2 medications, which decreased to a mean IOP of 13.8 ± 3.2 mmHg on 0.5 ± 0.7 medications at 3 years. Intraocular pressure and medication use results for all study eyes were significantly decreased from baseline (p <0.00001) at all intervals. Late postoperative complications included cataracts (19.1%) and transient IOP elevation (1.8%). CONCLUSIONS: Canaloplasty demonstrated significant and sustained IOP reductions accompanied by an excellent short- and long-term safety profile in adult patients with open-angle glaucoma.

Canaloplasty: Three-year results of circumferential viscodilation and tensioning of Schlemm canal using a microcatheter to treat open-angle glaucoma.

PURPOSE: To report 3-year results of the safety and efficacy of canaloplasty, a procedure involving circumferential viscodilation and tensioning of the inner wall of Schlemm canal to treat open-angle glaucoma. SETTING: Multicenter surgical sites. DESIGN: Nonrandomized multicenter clinical trial. METHODS: This study comprised adult open-angle glaucoma patients having canaloplasty or combined cataract-canaloplasty surgery. Qualifying preoperative intraocular pressures (IOPs) were at least 16 mm Hg with historical IOPs of at least 21 mm Hg. A flexible microcatheter was used to viscodilate the full circumference of the canal and to place a trabecular tensioning suture. Primary outcome measures included IOP, glaucoma medication use, and adverse events. RESULTS: Three years postoperatively, all study eyes (n = 157) had a mean IOP of 15.2 mm Hg ± 3.5 (SD) and mean glaucoma medication use of 0.8 ± 0.9 compared with a baseline IOP of 23.8 ± 5.0 mm Hg on 1.8 ± 0.9 medications. Eyes with combined cataract-canaloplasty surgery had a mean IOP of 13.6 ± 3.6 mm Hg on 0.3 ± 0.5 medications compared with a baseline IOP of 23.5 ± 5.2 mm Hg on 1.5 ± 1.0 medications. Intraocular pressure and medication use results in all eyes were significantly decreased from baseline at every time point (P<.001). Late postoperative complications included cataract (12.7%), transient IOP elevation (6.4%), and partial suture extrusion through the trabecular meshwork (0.6%). CONCLUSION: Canaloplasty led to a significant and sustained IOP reduction in adult patients with open-angle glaucoma and had an excellent short- and long-term postoperative safety profile. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.

Clinicopathologic correlation of capsulorhexis phimosis with anterior flexing of single-piece hydrophilic acrylic intraocular lens haptics.

UNLABELLED: We describe 2 cases in which patients with 4-looped single-piece hydrophilic acrylic intraocular lenses (IOLs) exhibited postoperative complications including capsulorhexis phimosis, decentration, tilt, hyperopic shift, and luxation leading to explantation of the IOL-capsular bag complex. The excessive capsule fibrosis led to anterior flexing of the IOL haptics in both cases, even in the presence of a capsular tension ring (CTR). Histopathological analyses revealed a thick fibrocellular tissue attached to the inner surface of the anterior capsules, corresponding to the anterior capsule opacification and folds. An amorphous substance was observed on the outer surface of the anterior capsule in the case with a CTR, suggesting pseudoexfoliation material. These and similar cases raise concerns about the postoperative behavior of highly flexible IOLs in the presence of excessive capsular bag fibrosis. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Detection of pyrogens adsorbed to intraocular lenses: evaluation of limulus amoebocyte lysate and in vitro pyrogen tests.

PURPOSE: To determine the ability of the limulus amoebocyte lysate (LAL) assay and the in vitro pyrogen test (IPT) to detect pyrogens adsorbed to intraocular lenses (IOLs). SETTING: Berlin Eye Research Institute, Berlin, Germany. METHODS: Fifteen of each of the following IOLs were used: MicroSil MS 612 ASP, AcrySof SA60AT, Superflex, Sensar, XACT, and LS-106 IOLs. The challenge organism suspensions were 10(3) CFU/mL and 10(4) CFU/mL Escherichia coli, 10(3) CFU/mL and 10(4) CFU/mL Pseudomonas putida, and 10(5) CFU/mL and 10(6) CFU/mL Staphylococcus epidermidis. Two IOLs of each model were incubated at room temperature for at least 2 days in 0.6 mL of 1 of the suspensions. They were then gamma sterilized. The extract of 1 IOL was tested with the LAL assay; the other IOL was tested with the IPT. RESULTS: The LAL was negative for all incubated IOLs. The IPT was positive for all IOLs incubated in E coli and P putida suspensions, with the MicroSil MS 612 ASP, AcrySof SA60AT, XACT, and LS-106 IOLs showing a severe reaction. The Superflex and Sensar IOLs had a slight to moderate response for lower bacterial concentrations and a moderate to severe response for higher concentrations. For S epidermidis, all IOLs showed a slight IPT response except XACT IOLs, which showed a nonpyrogenic response. CONCLUSIONS: Results indicate that the LAL test may fail to detect pyrogens adsorbed to IOLs and the IPT reliably detects pyrogens with a dose-dependent response. This has relevance in the investigation of toxic anterior segment syndrome outbreaks.

Canaloplasty: circumferential viscodilation and tensioning of Schlemm canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults: two-year interim clinical study results.

PURPOSE: To evaluate 2-year postsurgical safety and efficacy of canaloplasty (circumferential viscodilation and tensioning of the inner wall of Schlemm canal) to treat open-angle glaucoma (OAG). SETTING: Multicenter surgical sites. METHODS: This international prospective study comprised adult OAG patients having glaucoma surgery or combined glaucoma-cataract surgery. Qualifying preoperative intraocular pressure (IOP) was at least 16 mm Hg and historical IOP, at least 21 mm Hg. The full circumference of the canal was viscodilated and a trabecular tensioning suture placed with a microcatheter. Primary outcome measures included IOP and glaucoma medication use. RESULTS: At 24 months, all 127 eyes (127 patients) had a mean IOP of 16.0 mm Hg +/- 4.2 (SD) and mean glaucoma medication use of 0.5 +/- 0.8 (baseline values 23.6 +/- 4.8 mm Hg and 1.9 +/- 0.8 medications). Eyes with canaloplasty alone had a mean IOP of 16.3 +/- 3.7 mm Hg and 0.6 +/- 0.8 medications (baseline values 23.2 +/- 4.0 mm Hg and 2.0 +/- 0.8 medications). Eyes with combined glaucoma-cataract surgery had a mean IOP of 13.4 +/- 4.0 mm Hg and 0.2 +/- 0.4 medications (baseline values 23.1 +/- 5.5 mm Hg and 1.7 +/- 1.0 medications). The IOP and medication use results at all time points were statistically significant versus baseline (P <.001). The late postoperative follow-up identified 3 patients with elevated IOP. No other serious ocular or nonocular complications were reported. CONCLUSION: Canaloplasty was safe and effective in reducing IOP in adult patients with OAG.

Evaluating and defining the sharpness of intraocular lenses: microedge structure of commercially available square-edged hydrophilic intraocular lenses.

PURPOSE: To evaluate the microstructure of the edges of currently available hydrophilic acrylic intraocular lenses (IOLs) in terms of their deviation from an "ideal" square as a follow-up of preliminary in vitro studies of experimental poly(methyl methacrylate) IOLs and commercially available foldable hydrophobic IOLs. SETTING: Berlin Eye Research Institute, Berlin, Germany. METHODS: Twenty-four designs of hydrophilic acrylic IOLs were used in this study. For each design, a +20.0 diopter (D) IOL and a +0.0 D IOL (or the lowest available plus dioptric power) were evaluated. The IOL edge was imaged under low-vacuum (0.7 torr), high-magnification scanning electron microscopy (SEM) using an environmental microscope and standardized technique. The photographs were imported to a digital computer program, and the area above the posterior-lateral edge, representing the deviation from a perfect square, was measured in square microns. RESULTS: Currently available hydrophilic acrylic IOLs labeled as square edged had an area of deviation from a perfect square ranging from 60.84 to 871.51 microm(2) for the +20.0 D IOLs and from 35.52 to 826.55 microm(2) for the low-diopter IOLs. Although some differences in edge finishing between the IOLs analyzed were observed, edge surfaces of hydrophilic acrylic IOLs appeared overall smooth under environmental SEM. CONCLUSIONS: Analysis of the microstructure of the optic edge of currently available square-edged hydrophilic acrylic IOLs showed a large variation of the deviation area from a perfect square.

Unusual pattern of glistening formation on a 3-piece hydrophobic acrylic intraocular lens.

A 3-piece hydrophobic acrylic intraocular lens (IOL) was explanted from the left eye of a 68-year-old patient 26 days after implantation because of glistenings that impaired fundus visualization. The effect of the glistenings on the patient's visual function was unknown because of retinal issues. The fluid-filled vacuoles within the IOL optic were different from those described in clinical and experimental studies. They were initially observed 4 days after surgery and were very large. The glistening formation was reproduced experimentally by immersing the explanted IOL in balanced salt solution at 37 degrees C and analyzing the IOL at room temperature for up to 2 weeks. An IOL of the same design was used as a control. Although both IOLs were subjected to the same laboratory conditions, gross and light microscopic analyses confirmed that the pattern of the glistening formation differed between them. Analyses of the explanted IOL and the control IOL under differential scanning calorimetry, as well as by attenuated total reflection Fourier transform infrared spectroscopy, revealed slight differences between the IOLs.