Ocular sticks are used to absorb fluids during ophthalmic surgeries. Hence, this prospective study was conducted to evaluate the clinical performance, safety, and usability of Pro-optha® Ocular Sticks in comparison to an alternative device under the conditions of routine ophthalmic surgeries. Patients requiring eye surgery were randomly allocated into two equal groups, with the investigational device, Pro-ophta® Ocular Sticks, as the intervention group (IG) and the alternative stick as the comparator group (CG). Two types of surgery were performed. The study is also registered on the German Clinical Trials Register with ID DRKS00025690. 106 patients were included in the analyses. In both treatment groups, the investigator’s/surgeon’s general user satisfaction was rated as either “good” or “very good.” The non-inferiority hypothesis that the Pro-ophta® Ocular Stick is not rated worse in satisfaction than the alternative device was confirmed with statistical significance (p = 0.0005). At least 98.12

Purpose:This study focuses on the analysis of the rotational stability after implantation of a biconvex aspheric toric monofocal intraocular lens (IOL) with a double C-loop haptic-design in eyes with normal versus high axial lengths. Methods:This was a prospective comparative study including 150 eyes with corneal astigmatism (≥0.75D) implanted with the biconvex aspheric monofocal PODEYE toric IOL and assessed up to 1 year after surgery. From these 150 eyes, 81 and 69 eyes belonged to normal (≤23.9mm) and high (≥24mm) axial lengths, respectively. About 4-6 and 11-13 months postoperatively, refraction and rotational stability of the PODEYE toric IOL were evaluated to find possible differences among both groups. Results:At the last postoperative-visit, 74.07% of eyes were within ±0.50D and 95.06% of eyes were within ±1.00D of the target-refraction for the normal group and 92.75% and 100% for the high axial length group, respectively. For the normal group, 77.78% and 96.30% of eyes had a postoperative refractive cylinder of ≤0.50D and ≤1.00D, respectively; and for the high axial length group these percentages were 84.05% and 100%, respectively. About 81.84% of eyes in the normal and 94.20% of eyes in the high axial length group were <5 degrees of the intended axis. The mean IOL rotation was 2.93 ± 2.48 degrees in the normal axial length group, and 2.17 ± 1.73 degrees in the high axial length group. Based on the mixed ANOVA results, there is no evidence of a significant difference in IOL rotation over time, nor is there evidence that axial length plays a statistically significant role in rotational stability between 4-6 and 11-13 months postsurgery. Both groups exhibited similar and stable rotation outcomes. Conclusion:Our results reveal that the biconvex aspheric monofocal PODEYE toric IOL with double C-loop haptic-design shows excellent rotational stability without significant differences between eyes with normal and high axial lengths.

Purpose:This study aimed to evaluate one-year clinical outcomes in cataract patients with pre-existing corneal astigmatism implanted with a biconvex aspheric toric monofocal intraocular lens (IOL) with a double C-loop haptic-design. Methods:One hundred and eighteen patients (236 eyes) with corneal astigmatism (≥0.75D) were implanted bilaterally with the PODEYE toric IOL and assessed up to 1-year after surgery. Postoperative evaluation 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. Results:At the last postoperative visit, 74.6% and 95.8% of eyes were within ±0.50D and ±1.00D of the target refraction, respectively. About 78.0% and 97.5% of eyes showed a postoperative refractive cylinder of ≤0.50D and ≤1.00D, respectively. The mean manifest spherical equivalent value was 0.16±0.40D, and the mean refractive cylinder value was -0.42±0.33D. 97.5% and 100% of patients had a binocular UDVA and CDVA of ≥20/32, respectively. The mean binocular UDVA and CDVA were 0.01±0.09 and -0.03±0.07 logMAR, respectively. Under mesopic conditions, 79.5% and 89.8% of patients showed a binocular UDVA and CDVA of ≥20/32, respectively. The mean binocular UDVA and CDVA were 0.15±0.11 and 0.10±0.10 logMAR, respectively. Binocular contrast sensitivity function both under photopic and mesopic conditions was good. The mean absolute IOL rotation was 2.52±2.59 degrees with 98.56% of eyes having a rotation of less than 10 degrees. Conclusion:Bilateral implantation of an aspheric toric monofocal IOL with a double C-loop haptic design in cataract patients with corneal astigmatism provides good visual and refractive outcomes up to 1-year post-surgery.

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.

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.

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 (UDVA post ) was 0.25 ± 0.15 logMAR and was not statistically different from the mean preoperative corrected distance visual acuity (CDVA pre ), which was 0.24 ± 0.13 logMAR. Twenty-seven eyes (71%) reached UDVA post /CDVA pre ≥ 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 UDVA post . 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.

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.

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.

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 antivascular endothelial growth factor injections) because of localized central anterior surface and subsurface optic opacificatbn 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. (C) 2019 ASCRS and ESCRS.

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.

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.

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.

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.

In this article, we review recent research in suprachoroidal drug administration for the treatment of advanced, refractory, retinal disease. A microcatheter (iTRACK™ 400) has been used to access and deliver drugs to the suprachoroidal space. This technology has been investigated in several animal models as well as in patients with advanced disease stages and/or who are unresponsive to conventional treatments. In groups with either age-related macular degeneration (AMD) and/or macular oedema resulting from other diseases, significant effects were achieved by using this technology to apply steroids and/or anti-vascular endothelial growth factor (VEGF) drugs, with no surgical or postoperative complications observed. Suprachoroidal drug administration directly adjacent to the choroid in the submacular region might therefore be a potential treatment for many retinal diseases. Human pilot studies in patients with advanced, refractory retinal disease that is unresponsive to conventional treatments showed some increase in residual vision and significant reduction of macular oedema, with few complications. Prospective trials are necessary to confirm the pilot results obtained by different research groups.

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.Financial Disclosure(s): The authors have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2012; 119: 266-271 (C) 2012 by the American Academy of Ophthalmology.

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.