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This case report outlines the successful management of angle recession with gonioscopy-assisted transluminal trabeculotomy (GATT). A 53-year-old male with a history of blunt trauma to the left eye resulting in angle recession presented with an IOP of 38 mm Hg on four antiglaucoma agents. Following GATT, a notable reduction in IOP to 10 mm Hg was observed on the first postoperative day. Subsequent one year follow-up visit demonstrated sustained improvement, with IOP stabilizing at 18 mm Hg without the need for antiglaucoma medication. This is the first case report that demonstrates the role of GATT in the management of angle recession.
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BACKGROUND: To investigate the effect of perioperative intraocular pressure (IOP) lowering medications on controlling postoperative IOP following uncomplicated phacoemulsification. METHODS: Ovid MEDLINE, EMBASE, and Cochrane CENTRAL databases were searched up until November 2022. Randomised controlled trials (RCTs) that assessed IOP change via applanation tonometry in medicated and control arms following uncomplicated cataract surgery in healthy eyes were included. The primary outcome was the weighted mean difference (WMD) of IOP at 2-8 h, 12-24 h, and 1-7 days postoperatively within each medication class or common fixed-combination formulations. Risk of bias was assessed using the revised risk of bias in randomised trials (RoB-2). Level of evidence was rated using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) RESULTS: From 702 screened articles, 30 RCTs involving 2986 eyes were included. There was a statistically significant reduction in IOP favouring treatment arms at 2-8 h (WMD = -3.87 mmHg; 95% CI [-4.75, -3.00]; p < 0.001) and 12-24 h (WMD = -2.69 mmHg; 95% CI [-3.36, -2.02]; p < 0.001), with the effect wearing off beyond 1 day (p = 0.18). Between medication classes, the largest effect at both 2-8 h and 12-24 h was observed with intracameral cholinergics or fixed-combination carbonic anhydrase inhibitor-beta-blocker (FCCB) formulations. Conversely, the smallest effect was observed with prostaglandin analogues, alpha-agonists, and topical carbonic anhydrase inhibitors (CAIs). CONCLUSION: Prophylaxis against acute IOP elevations following uncomplicated cataract surgery is effective. FCCB and intracameral cholinergics are the most effective ocular antihypertensive agents, while alpha-agonists, prostaglandin analogues, and topical CAIs were found to be the least effective. These findings may inform future surgical guidelines.
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Antihipertensivos , Presión Intraocular , Facoemulsificación , Humanos , Presión Intraocular/efectos de los fármacos , Presión Intraocular/fisiología , Antihipertensivos/uso terapéutico , Complicaciones Posoperatorias/prevención & control , Tonometría Ocular , Hipertensión Ocular/prevención & controlRESUMEN
PURPOSE: To discuss the implications of large language models (LLMs) in ophthalmology research, as well as the associated ethical considerations. DESIGN: Perspective. METHODS: This discussion reviews the potential uses of LLMs such as ChatGPT in ophthalmology research, highlights the associated threats and ethical considerations, and proposes solutions for the use of LLMs in ophthalmology research and scientific writing. RESULTS: With the increasing interest in LLMs, such as ChatGPT, their diverse utility has been widely explored, including their application in research and scientific writing. LLMs have the potential to guide researchers throughout the different stages of their research, from idea generation to drafting a scientific piece. However, there are significant ethical concerns and challenges related to scientific integrity in ophthalmology research that should be addressed by scientific journals. Our review of the 10 highest-impact-factor ophthalmology journals revealed that the number of journals addressing this topic in their submission guidelines is rapidly increasing. Therefore, we propose certain domains that all journals should consider regarding the use of LLMs in research. CONCLUSIONS: As LLMs continue to improve, their use in scientific writing will remain a contentious issue due to the ethical dilemmas involved in determining the appropriate scope of their use. This article reviews the ethical dilemmas related to the use of LLMs in ophthalmology research and calls for the prompt development of guidelines for their ethical use in manuscript writing as ophthalmology journals update their editorial policies with respect to LLMs.
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Oftalmología , Humanos , Escritura , Políticas Editoriales , LenguajeRESUMEN
OBJECTIVE: To compare the prevalence of angle closure in eyes with retinal vein occlusion (RVO) with control eyes and assess the possible association between angle-closure and RVO. PATIENTS AND METHODS: This prospective, blinded case-control study included patients with a history of RVO (cases) and control individuals matched for age and refractive error. Clinical characteristics and angle-based structures derived from anterior-segment optical coherence tomography (AS-OCT) were analyzed. RESULTS: Eighty-eight patients (44 per group) were included. The average age of the RVO and control groups was 59.8 ± 11.6 years and 60.8 ± 9.0 years, respectively (pâ¯=â¯0.667). There were no significant differences in terms of clinical characteristics between the 2 groups, including intraocular pressure (pâ¯=â¯0.837) and Shaffer gonioscopy grading (pâ¯=â¯0.620). None of the AS-OCT-derived angle characteristics were significantly different between the 2 groups. The number of angle-closure diagnoses between the RVO group (1 primary angle closure and 7 primary angle-closure suspects) and the control group (6 primary angle-closure suspects) did not differ significantly (pâ¯=â¯0.560). Anterior-chamber depth (ACD) was shallower in RVO eyes (2.72 ± 0.31 mm) than in the contralateral non-RVO eyes (2.76 ± 0.31 mm; pâ¯=â¯0.014). CONCLUSIONS: This prospective, blinded, matched case-control study did not evidence any significant differences in clinical and AS-OCT-derived structural measures between RVO and control eyes. However, RVO eyes, compared with their contralateral non-RVO eyes, had a slightly shallower ACD. These findings collectively suggest that an association between primary angle-closure mechanisms and RVO is unlikely. However, the shallower ACD in RVO eyes could potentially put them at higher risk for intermittent or permanent pupillary block.
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PURPOSE: Anterior segment optical coherence tomography (AS-OCT) is an emerging imaging modality with an expanding role in glaucoma diagnosis and management. We present a series of two cases of iatrogenic cyclodialysis cleft and their conservative management being directly informed by non-invasive AS-OCT monitoring. OBSERVATIONS: Retrospective case series. A 51 year-old male and a 29 year-old male each underwent gonioscopy-assisted transluminal trabeculotomy for uncontrolled glaucoma with a cyclodialysis cleft being diagnosed postoperatively and then monitored using serial AS-OCT images. In both cases, conservative medical management was initially employed. Worsening hypotony maculopathy and decreasing best corrected visual acuity were evident in both cases at times when gonioscopy yielded inadequate visualization to meaningfully inform treatment decisions. Escalation to more invasive therapies was therefore considered. AS-OCT imaging revealed consistent anatomical improvement at each follow-up and ultimately both clefts closed without treatment escalation. CONCLUSIONS AND IMPORTANCE: AS-OCT played a critical role in the diagnosis and directly informed the conservative management of both of these cases. This non-invasive imaging modality may allow for deferral of invasive treatment escalation in some cases of cyclodialysis cleft.
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PURPOSE: To assess 5-year effectiveness and safety of 2 iStent® trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) not controlled on 1 medication. MATERIALS AND METHODS: This prospective, interventional, single-arm, multi-surgeon study (NCT #1252862, clinicaltrials.gov) enrolled eyes with OAG, preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 ocular hypotensive medication, and 22-38 mmHg after medication washout. Eyes underwent standalone implantation of 2 iStent devices and were followed through 60 months postoperatively. Efficacy was quantified by mean diurnal IOP and medication usage. Efficacy endpoints included the proportion of eyes with ≥20% IOP reduction versus baseline unmedicated IOP (primary efficacy), and the proportion of eyes with IOP ≤18 mmHg (secondary efficacy) without medication or secondary glaucoma surgery. Safety parameters included visual acuity, cup-to-disc ratio, visual field, and complications and adverse events. RESULTS: Preoperative mean IOP on 1 medication was 20.6 ± 2.0 mmHg and post-washout unmedicated IOP was 24.1 ± 1.4 mmHg (n = 39). At 5 years postoperative, medication-free mean diurnal IOP reduced to 14.5 ± 2.2 mmHg, constituting a 40% decrease versus preoperative washed-out IOP (p < .0001). In addition, this 5-year medication-free IOP constituted a 30% decrease versus preoperative IOP on 1 medication (p < .0001). At Month 60, 89.7% (26/29) of eyes achieved the primary efficacy endpoint of ≥20% IOP reduction versus baseline unmedicated IOP, and 86.2% (25/29) of eyes achieved the secondary efficacy endpoint of IOP ≤18 mmHg, without medication or secondary glaucoma surgery. Throughout follow-up, 89.7-91.3% of eyes were on no medications. Favorable safety included no secondary glaucoma surgeries, minimal adverse events, and stable visual acuity, cup-to-disc ratio, and visual fields through 5 years postoperative. CONCLUSIONS: This prospective interventional study demonstrates persistent 5-year reductions in IOP and freedom from medications, together with favorable safety, following implantation of 2 first-generation trabecular micro-bypass stents in eyes with OAG on 1 preoperative medication.
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Implantes de Drenaje de Glaucoma , Glaucoma de Ángulo Abierto/cirugía , Presión Intraocular/fisiología , Stents , Malla Trabecular/cirugía , Trabeculectomía/métodos , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Glaucoma de Ángulo Abierto/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Factores de Tiempo , Resultado del Tratamiento , Agudeza Visual , Campos Visuales/fisiologíaRESUMEN
PURPOSE: To assess the 1-year surgical outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in young to middle-aged patients. DESIGN: Retrospective case series. PARTICIPANTS: Eyes of patients between 18 and 64 years of age who underwent GATT, with and without concomitant cataract surgery, at 2 academic centers in Montreal, Canada. METHODS: Success was defined as intraocular pressure (IOP) between 6 and 21 mmHg (criterion A) or between 6 and 18 mmHg (criterion B) and a relative IOP reduction of 20% or more compared with baseline. Failure consisted of not meeting the success criteria at 2 or more consecutive visits after the first postoperative month, reoperation because of uncontrolled IOP or disease progression, or loss of light perception. Predictors of success and postoperative changes in outcome measures, including IOP and medication use, were assessed. Intraoperative and postoperative adverse events were noted. MAIN OUTCOME MEASURES: Success, IOP, and medication reduction at the 1-year follow-up and baseline predictors of surgical success. RESULTS: Fifty-six eyes with a mean age of 46.94 ± 11.81 years and preoperative IOP of 27.70 ± 10.30 mmHg taking 3.73 ± 0.98 glaucoma medications were included. At 1 year, IOP decreased from 27.70 ± 10.30 mmHg before surgery to 14.04 ± 3.75 mmHg (49% reduction; P < 0.001) and medication use decreased from 3.73 ± 0.98 medications before surgery to 1.82 ± 1.47 (51% reduction; P < 0.001). The 12-month success was 84% (according to both criteria), and younger age at diagnosis of glaucoma (18-39 years) was predictive of surgical success. The most common postoperative adverse events included transient hyphema, IOP spikes, and transient microcystic corneal edema. CONCLUSIONS: A paucity of evidence exists regarding the efficacy of GATT in young to middle-aged adults. Our results highlight that this surgical procedure has good 1-year outcomes with an acceptable safety profile, supported by the significant IOP and medication reduction observed after surgery. With younger age at diagnosis of glaucoma being a predictor of surgical success, the pathophysiologic features of open-angle glaucoma in younger patients may be more localized to the trabecular meshwork, therefore making GATT a particularly suitable procedure for these patients.
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Glaucoma de Ángulo Abierto , Trabeculectomía , Adulto , Estudios de Seguimiento , Glaucoma de Ángulo Abierto/cirugía , Gonioscopía , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Purpose: To evaluate the early postoperative outcomes of trabecular micro-bypass stents and concomitant cataract surgery (TMS-CS) with and without postoperative corticosteroid therapy. Methods: Prospective, interventional matched, consecutive case series comparing outcomes of open-angle glaucoma patients who underwent TMS-CS with and without postoperative corticosteroid therapy. Primary outcome was intraocular pressure (IOP) changes up to 6 months postoperatively and the secondary outcomes included number of postoperative medications, IOP spikes, peripheral anterior synechia (PAS), and best-corrected visual acuity improvements. Results: The clinical outcomes of 97 eyes-49 in the steroid group age- and IOP-matched with 48 in the nonsteroid group-were analyzed. Baseline IOP in steroid and nonsteroid groups were 16.22 ± 3.98 and 16.04 ± 3.99 (P = 0.822), respectively. Both IOP and number of antiglaucoma medications significantly decreased postoperatively (P < 0.001), however, there were no group differences at different time points (P = 0.653 and P = 0.168, respectively). At 1 week postoperatively, the steroid group had higher number of IOP spikes (n = 9) compared with nonsteroid group (n = 2, P = 0.022). There was no significant difference in postoperative PAS between the steroid group (n = 6) and nonsteroid group (n = 6, P = 0.970). Vision improved significantly postoperatively (P < 0.001) with no group differences at different time points (P = 0.322). Conclusions: TMS-CS decreased IOP and number of antiglaucoma medications while improving visual acuity both with and without the use of postoperative steroids. Limiting the use of postoperative steroids in combined microbypass stents and cataract surgery appears to be a safe surgical option and may help minimize acute elevations in IOP in the early postoperative period.
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Corticoesteroides/administración & dosificación , Extracción de Catarata/métodos , Glaucoma de Ángulo Abierto/cirugía , Presión Intraocular/efectos de los fármacos , Administración Oftálmica , Anciano , Anciano de 80 o más Años , Femenino , Implantes de Drenaje de Glaucoma , Humanos , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Estudios Prospectivos , Stents , Agudeza VisualRESUMEN
PURPOSE: The effectiveness of selective laser trabeculoplasty (SLT) was compared with argon laser trabeculoplasty (ALT) in a randomized clinical trial for patients with medically uncontrolled open-angle glaucoma who have previously received 360° SLT. DESIGN: An active equivalence parallel armed randomized control trial. PARTICIPANTS: Patients with open-angle glaucoma including pigmentary dispersion syndrome and pseudoexfoliation syndrome were enrolled into the study from 7 different sites across Canada. METHODS: One setting of 180° of either SLT or ALT was assigned randomly and applied to each participant. MAIN OUTCOME MEASURES: The change in intraocular pressure (IOP) from baseline to 12 months was compared between the 2 groups. RESULTS: A total of 132 patients were recruited, 2 of which dropped out early in the study, leaving 130 patients who completed the study as per protocol. For those, the study's primary outcome was calculated. The IOP change at 1 year in comparison to baseline for SLT vs. ALT was found to be different by 0.33 mmHg between the 2 groups (3.16 for SLT and 2.83 for ALT) and was not statistically significant (P = 0.71) Further analysis, though, showed that SLT had a significantly lower IOP reduction at early time points: 1 week and 1 month, but this effect was lost by 3 months. Corresponding to this finding was the strong trend for ALT to fail more quickly than SLT. Although repeatable, the first repeat SLT reduced IOP to only about half compared with initial SLT treatment. CONCLUSIONS: The comparison at 12 months following the laser therapy showed that both modalities lowered the IOP with approximately 3 mmHg, yet essentially all of the time-to-failure analyses favored SLT over ALT. The repeat SLT effect was found to be half of the initial treatment.
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Síndrome de Exfoliación/cirugía , Glaucoma de Ángulo Abierto/cirugía , Terapia por Láser/métodos , Láseres de Gas/uso terapéutico , Malla Trabecular/cirugía , Trabeculectomía/métodos , Anciano , Estudios de Equivalencia como Asunto , Femenino , Glaucoma de Ángulo Abierto/fisiopatología , Humanos , Presión Intraocular/fisiología , Masculino , Persona de Mediana Edad , Método Simple Ciego , Tonometría Ocular , Resultado del TratamientoRESUMEN
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.
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Implantes de Drenaje de Glaucoma , Glaucoma de Ángulo Abierto/terapia , Procedimientos Quirúrgicos Oftalmológicos/métodos , Prostaglandinas/farmacología , Stents , Malla Trabecular/trasplante , Agudeza Visual , Femenino , Estudios de Seguimiento , Glaucoma de Ángulo Abierto/diagnóstico , Glaucoma de Ángulo Abierto/fisiopatología , Humanos , Presión Intraocular/fisiología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Tiempo , Malla Trabecular/cirugía , Resultado del Tratamiento , Campos Visuales/fisiologíaRESUMEN
Aim: This meta-analysis explores the efficacy and adverse event profile of the iStent, an ab interno implant for the treatment of open-angle glaucoma. Methods: A systematic literature search of Ovid MEDLINE and EMBASE was used to identify peer-reviewed original studies that provided efficacy data on the first or second generation iStent for at least five eyes. Intraocular pressure (IOP) was the primary efficacy endpoint, while the number of medication classes was the secondary outcome. Weighted mean differences were reported for continuous endpoints, while a relative risk was computed for dichotomous variables. Review Results: The search revealed 545 results, of which 1767 eyes from 28 studies were included. The cohort age was 71.4 ± 5.4 years, and 44.9% of patients were male. There was a significantly greater IOP reduction after the use of two first-generation stents compared to one, irrespective of phacoemulsification status (p < 0.001). Additionally, there was a significantly greater IOP reduction following iStent alone relative to phaco-iStent for the first-generation iStent (p < 0.001) and the iStent inject (p < 0.001). For the first generation stent, combined phaco-iStent provided a greater level of IOP reduction (p < 0.001) and reduction in the number of medication classes relative to phacoemulsification alone (p < 0.001). In total, 22.5% of eyes that received iStent implantation sustained some type of adverse event. The most common adverse events were intraocular pressure elevation, stent blockage or obstruction, stent malposition and hyphema. Conclusion and Clinical Significance: Statistically significant differences in efficacy outcomes exist between different numbers of stents and the presence or absence of concurrent phacoemulsification.How to cite this article: Popovic M, Campos-Moller X, Saheb H, Ahmed IIK. Efficacy and Adverse Event Profile of the iStent and iStent Inject Trabecular Micro-bypass for Open-angle Glaucoma: A Meta-analysis. J Curr Glaucoma Pract 2018;12(2):67-84.
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BACKGROUND: To evaluate artifacts in macular ganglion cell inner plexiform layer (GCIPL) thickness measurement in eyes with retinal pathology using spectral-domain optical coherence tomography (SD OCT). METHODS: Retrospective analysis of color-coded maps, infrared images and 128 horizontal B-scans (acquired in the macular ganglion cell inner plexiform layer scans), using the Cirrus HD-OCT (Carl Zeiss Meditec, Dublin, CA). The study population included 105 eyes with various macular conditions compared to 30 eyes of 30 age-matched healthy volunteers. The overall frequency of image artifacts and the relative frequency of artifacts were stratified by macular disease. RESULTS: Scan errors and artifacts were found in 55.1% of the 13,440 B-scans in eyes with macular pathology and 26.8% of the 3840 scans in normal eyes. Segmentation errors were the most common scan error in both groups, with more common involvement of both segmentation borders in diseased eyes and anterior segmentation border in normal eyes. CONCLUSION: Segmentation errors and artifacts in SD OCT GCA are common in conditions involving the macula. These findings should be considered when assessing macular GCIPL thickness and careful assessment of scans is suggested.
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Glaucoma is one of the most common causes of blindness worldwide, and its prevalence is increasing. The aim of the present review is to describe the current medical and surgical treatment trends in the management of open-angle glaucoma. There has been an increase in the availability of glaucoma medications and the use of laser trabeculoplasty over the past decade, with a subsequent decrease in invasive incisional surgery. In addition, a new class of glaucoma procedures, termed microinvasive glaucoma surgery, has emerged, which aims to fill the gap between conservative medical management and more invasive surgery.
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Glaucoma/cirugía , Presión Intraocular , Terapia por Láser/tendencias , Trabeculectomía/tendencias , Glaucoma/fisiopatología , HumanosRESUMEN
PURPOSE: To report the occurrence and management of severe infectious scleritis in a 75 year-old woman following intravitreal ranibizumab injection. OBSERVATIONS: A 75 year-old monocular woman receiving monthly intravitreal ranibizumab injection for wet age related macular degeneration in the left eye presented with severe dull pain, decreased vision, and scleral melt with discharge 2 weeks after her last injection. The dilated fundus exam was devoid of vitritis. The patient was admitted to our hospital for both diagnostic and therapeutic purposes. She was initially started on aggressive oral and topical antibiotics, but showed no significant improvement. The scleral cultures were positive for Pseudomonas aeruginosa. In view of the aggressive nature of her infection, intravenous antibiotics were added to the treatment regimen. The patient recovered her baseline visual function after two weeks of intravenous, oral and, topical antibiotics. CONCLUSIONS AND IMPORTANCE: To our knowledge, this is the first case of anterior infectious necrotizing scleritis secondary to Pseudomonas aeruginosa infection following intravitreal ranibizumab injection. Clinicians performing intravitreal injections should have a high index of suspicion for iatrogenic infections including scleritis and endophthalmitis, as these infections require aggressive topical and systemic antibiotics as well as possible hospitalization.
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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.
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PURPOSE: To compare the outcomes of combined cataract surgery with trabecular microbypass stents and ab interno trabeculotomy in patients with open-angle glaucoma. SETTING: University of Toronto, Toronto, Ontario, and University of Montreal, Montreal, Quebec, Canada, and Glaucoma Associates of Texas, Dallas, Texas, USA. DESIGN: Retrospective case series. METHODS: Patients with primary open-angle, pseudoexfoliative, or pigmentary dispersion glaucoma were included. Primary outcome measures were intraocular pressure (IOP), postoperative medications, success (IOP ≤18 mm Hg, no glaucoma medications or reoperations), and postoperative adverse events. RESULTS: The average patient age was 76.5 years ± 12 [SD]. Forty-nine eyes had phacoemulsification and 2 had stent implantations; 52 eyes had phacoemulsification and trabeculotomy surgery with a 12-month postoperative follow-up. The analysis of variance indicated a significant reduction in mean IOP from baseline to 12 months for stent (19.6 ± 5.3 mm Hg to 14.3 ± 3.1 mm Hg; P < .001) and trabeculotomy (20.6 ± 6.8 mm Hg to 17.3 ± 6.5 mm Hg; P < .001) and lower mean IOP at 12 months in the stent group (P = .01). The median number of glaucoma medications decreased from baseline to 12 months in both groups and was lower in the stent group at 3, 6, and 12 months. Thirty-nine percent (19 eyes) in the stent group and 14% (7 eyes) in the trabeculotomy group achieved success at 12 months (P = .006). The incidence of hyphema was lower in the stent group (P = .008). CONCLUSIONS: Both types of surgery achieved a significant reduction in IOP and medication use at 12 months, with the stent group achieving higher success and a reduced incidence of postoperative hyphema. FINANCIAL DISCLOSURE: Dr. Ahmed is a consultant to and investigator for Glaukos Corp., Ivantis, Inc., Transcend Medical, Inc., and Aquesys, Inc., and has received speaker honoraria from Neomedix, Inc. Dr. Saheb has received travel funding from Glaukos Corp., Ivantis, Inc., and Transcend Medical, Inc., and a research grant from Ivantis, Inc. Dr. Harasymowycz has received a research grant from Ivantis, Inc. Dr. Fellman is a consultant to Endo Optiks, Inc., and has received honoraria from Optous and research funds from Ivantis, Inc., Glaukos Corp., and Transcend Medical, Inc. No other author has a financial or proprietary interest in any material or method mentioned.
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Stents Liberadores de Fármacos , Implantes de Drenaje de Glaucoma , Glaucoma de Ángulo Abierto/cirugía , Facoemulsificación/métodos , Trabeculectomía/métodos , Anciano , Anciano de 80 o más Años , Síndrome de Exfoliación/cirugía , Femenino , Estudios de Seguimiento , Glaucoma de Ángulo Abierto/fisiopatología , Gonioscopía , Humanos , Presión Intraocular/fisiología , Masculino , Persona de Mediana Edad , Implantación de Prótesis/métodos , Estudios Retrospectivos , Tonometría Ocular , Malla Trabecular/cirugíaRESUMEN
PURPOSE: To assess the biocompatibility of a novel implant made of Nitinol (nickel-titanium alloy), designed to improve aqueous humor outflow. MATERIALS AND METHODS: In the first arm of biocompatibility testing, microstents were surgically inserted into Schlemm's canal (SC) of 2 non-human primates (NHPs), and a third NHP served as a surgical sham control. After 13 weeks the animals were killed, and the eyes were examined by light and scanning electron microscopy. Two masked investigators evaluated the histology sections. The second arm utilized 8 New Zealand white rabbits; each rabbit received a microstent inserted into the sclera and subconjunctival space by means of passage across the anterior chamber thus providing contact with several representative ocular tissues. The fellow eye of each rabbit underwent a sham procedure without microstent insertion. The rabbits were killed after 26 weeks, and a trained ocular pathologist examined the specimens using light microscopy. RESULTS: Histologic and scanning electron microscopy analysis of the NHPs demonstrated that the microstents were located in SC. There was no evidence of an acute or chronic inflammatory response, granulation response, or fibrosis in the outflow system or in adjacent tissues. Rabbit eyes showed minimal mononuclear cell infiltration and minimal fibrotic responses at the site of the implants when compared with sham-treated control eyes. CONCLUSIONS: The Hydrus Microstent was associated with minimal inflammation in both NHP and rabbit eyes with extended follow-up. These preclinical studies demonstrate that the Hydrus Microstent appears to have excellent long-term biocompatibility.
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Aleaciones , Materiales Biocompatibles , Implantes de Drenaje de Glaucoma , Limbo de la Córnea/cirugía , Limbo de la Córnea/ultraestructura , Andamios del Tejido , Animales , Humor Acuoso/fisiología , Femenino , Presión Intraocular/fisiología , Limbo de la Córnea/metabolismo , Macaca fascicularis , Masculino , Ensayo de Materiales , Microscopía Electrónica de Rastreo , Conejos , EscleróticaRESUMEN
Trabecular micro-bypass stents, commonly known as iStents, are micro-invasive glaucoma surgery (MIGS) devices used to treat open-angle glaucoma. Like other MIGS procedures that enhance trabecular outflow, the iStent lowers intraocular pressure (IOP) by creating a direct channel between the anterior chamber and Schlemm's canal. iStents are typically implanted at the time of phacoemulsification for patients with open-angle glaucoma and visually significant cataracts. This review summarizes the published data regarding the efficacy, safety, and cost considerations of trabecular micro-bypass stents. Most studies found statistically significant reductions in mean IOP and ocular medication use after combined phacoemulsification with single or double iStent implantation. The devices were found to be very safe, with a safety profile similar to that of cataract surgery. Complications were infrequent, with the most common complications being temporary stent obstruction or malposition, which resolved with observation or secondary procedures. Future studies are needed to evaluate long-term outcomes, patient satisfaction, cost effectiveness, and expanded indications.