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1.
Curr Opin Ophthalmol ; 24(4): 281-7, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23703461

RESUMO

PURPOSE OF REVIEW: This study provides an overview of the three types of corneal inlays now in use for the correction of presbyopia and reviews recently published evidence of the inlays' safety and efficacy. RECENT FINDINGS: Results for corneal reshaping and refractive inlays are promising, but very limited. Small-aperture inlays are already in widespread use and have been shown to improve uncorrected near and intermediate vision without a significant loss in distance acuity or an unacceptable increase in visual symptoms. Complications have been minimal, but the inlays may be removed if necessary. They do not prevent visualization or imaging of the retina and may be retained during subsequent cataract surgery. SUMMARY: The presbyopic demographic is large and growing, with a high level of interest in spectacle independence. There is currently no other effective solutions for presbyopes who desire good uncorrected vision at all distances without the risks of intraocular surgery or the visual compromises of monovision. Additional research is needed, but the future for corneal inlay technology is bright.


Assuntos
Substância Própria/cirurgia , Presbiopia/cirurgia , Próteses e Implantes , Substância Própria/fisiopatologia , Humanos , Procedimentos Cirúrgicos Oftalmológicos , Presbiopia/fisiopatologia , Implantação de Prótese , Refração Ocular/fisiologia , Acuidade Visual/fisiologia
2.
Clin Ophthalmol ; 17: 2219-2230, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37564159

RESUMO

Purpose: To compare the preservative-free corticosteroid 0.2% betamethasone sodium phosphate BID (SURF-201) to vehicle BID in patients undergoing routine cataract surgery. Methods: Phase 2, multicenter, randomized (1:1 ratio), double-masked, vehicle-controlled, parallel-group study in patients scheduled for uncomplicated cataract surgery without the aid of a femtosecond laser. Subjects instilled topical medications for 16 days beginning the day before cataract surgery (Day -1), 1 dose administered at least 1 hour prior to cataract surgery (on Day 0) and 1 dose on the evening after cataract surgery, and then 2 doses administered each day through Day 15; patients were re-evaluated on Days 22 and 32 to ensure no rebound inflammation. Primary outcome was the difference in the proportion of subjects with anterior chamber cell (ACC) grade 0 between the two groups at Day 15. Secondary outcomes included pain scores and overall safety. Results: There was a statistically significant difference (P=0.004) in the proportion of subjects in the SURF-201 treatment group with an ACC grade of 0 at Day 15 (n=22/39 [56.4%]) compared to subjects in the vehicle treatment group (n=9/43 [20.9%]). There was no statistically significant difference (P=0.528) in the proportion of subjects in the SURF-201 treatment group who had a visual analog scale pain score of 0 at Day 15 (n=35/38 [89.7%]) compared to subjects in the vehicle group (n=33/40 [82.5%]). A slightly higher incidence of adverse events occurred in subjects in the SURF-201 treatment group (n=27/40 [67.5%]) compared to the vehicle treatment group (n=23/43 [53.5%]). Conclusion: SURF-201 is an effective topical, preservative-free corticosteroid when dosed BID for the treatment of postoperative inflammation and prevention of pain in a post-cataract population.

3.
J Ocul Pharmacol Ther ; 38(10): 657-663, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36327101

RESUMO

Background: This phase 2 study evaluated the therapeutic potential of netarsudil to reduce corneal edema and to improve vision in patients with Fuchs corneal dystrophy (FCD). Methods: Patients (N = 40) with baseline central corneal thickness (CCT) of ≥600 µm and best-corrected visual acuity (BCVA) of 70-20 letters (20/40-20/400 Snellen equivalent) were randomized 1:1 to receive netarsudil once a day (QD) or twice a day (BID) for 8 weeks. Primary endpoint was mean CCT change from baseline at week 4. Results: Netarsudil QD and BID significantly reduced CCT at week 4 [mean change (standard error of mean), 28.4 (7.99) µm, P = 0.0021; and 20.1 (8.75) µm, P = 0.0335, respectively]. Five (12.5%) patients achieved complete resolution of corneal edema at week 4. BCVA improved by 3.2 (2.76) letters with QD and 1.5 (2.84) letters with BID, and 10 (25%) patients [5 with QD (P = 0.0078) and 5 with BID (P = 0.0096)] gained ≥10 letters at week 4. Improvements in CCT and vision were observed at week 2 and persisted at week 8, without significant differences between the 2 doses at any time point. Netarsudil QD significantly improved visual acuity and glare factor scores on the Visual Function and Corneal Health Status (V-FUCHS) questionnaire at weeks 4 and 8 (mean change, -0.4 to -0.3; P ≤ 0.0200). Netarsudil was well tolerated. Reticular edema developed in one (2.5%) patient with BID, which resolved with treatment discontinuation. Conclusions: Netarsudil QD led to significant reductions in corneal edema as well as improvements in vision and patient-reported symptoms of glare and visual impairment in patients with FCD. Clinical Trial Registration Number: NCT04498169.


Assuntos
Edema da Córnea , Distrofia Endotelial de Fuchs , Humanos , Edema da Córnea/tratamento farmacológico
4.
J Med Econ ; 24(1): 410-420, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33210975

RESUMO

AIMS: To assess the cost-effectiveness of corneal collagen cross-linking (CXL) versus no CXL for keratoconus in the United States (US). METHODS: A discrete-event microsimulation was developed to assess the cost-effectiveness of corneal cross-linking (CXL, Photrexa + KXL combination product) versus no CXL for patients with keratoconus. The lifetime model was conducted from a US payor perspective. The source for CXL efficacy and safety data was a 12-month randomized, open-label, sham-controlled, multi-center, pivotal trial comparing CXL versus no CXL. Other inputs were sourced from the literature. The primary outcome was the incremental cost per quality-adjusted life year gained. Costs (2019 USD) and effects were discounted 3% annually. The impacts of underlying uncertainty were evaluated by scenario, univariate, and probabilistic analyses. RESULTS: Starting at a mean baseline age of 31 years and considering a mixed population consisting of 80% slow-progressors and 20% fast-progressors, the CXL group was 25.9% less likely to undergo penetrating keratoplasty (PK) and spent 27.9 fewer years in advanced disease stages. CXL was dominant with lower total direct medical costs (-$8,677; $30,994 versus $39,671) and more QALYs (1.88; 21.80 versus 19.93) compared to no CXL. Considering the impact of reduced productivity loss in an exploratory scenario, CXL was associated with a lifetime cost-savings of $43,759 per patient. CXL was cost-effective within 2 years and cost-saving within 4.5 years. LIMITATIONS: Limitations include those that are common to similar pharmacoeconomic models that rely on disparate sources for inputs and extrapolation on short-term outcomes to a long-term analytical horizon. CONCLUSIONS: Keratoconus is a progressive and life-altering disease with substantial clinical, economic, and humanistic consequences. The economic value of cross-linking is maximized when applied earlier in the disease process and/or younger age, and extends to improved work productivity, out-of-pocket costs, and quality of life.


Assuntos
Ceratocone , Fotoquimioterapia , Colágeno/uso terapêutico , Reagentes de Ligações Cruzadas/uso terapêutico , Seguimentos , Humanos , Recém-Nascido , Ceratocone/tratamento farmacológico , Modelos Econômicos , Fármacos Fotossensibilizantes/uso terapêutico , Qualidade de Vida , Riboflavina/uso terapêutico , Raios Ultravioleta
5.
Clin Ophthalmol ; 14: 2739-2746, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33061256

RESUMO

PURPOSE: To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days. DESIGN: Prospective, open-label, randomized, single-site study. SUBJECTS: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days. METHODS: Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period. RESULTS: Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable. CONCLUSION: The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.

6.
Transl Vis Sci Technol ; 9(12): 19, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33240572

RESUMO

Purpose: To evaluate the intraocular pressure (IOP)-lowering effect of a multi-pressure dial (MPD) at targeted negative pressure settings. Methods: Prospective, intrasubject controlled study of 65 healthy subjects randomized to receive no negative pressure for 60 minutes or negative pressure application at designated levels of 25%, 50%, and 75% of baseline IOP for 20 minutes each. The main outcome measure was mean IOP with application of negative pressure. Results: In the study eye group, from a baseline IOP of 15.8 ± 3.6 mm Hg, the mean IOP was 13.5 ± 3.4, 11.5 ± 3.1, and 10.2 ± 2.7 mm Hg with negative pressure settings of 25%, 50% and 75%, respectively. In the control eye group, from a baseline IOP of 15.5 ± 3.0 mm Hg, the mean IOP values at the same time points, without negative pressure, were 15.6 ± 3.0, 15.5 ± 2.5 and 15.3 ± 2.4 mm Hg. The difference between the mean IOPs of the two groups was significantly different at all negative pressure settings (P < 0.001) in comparison with baseline. There was one minor adverse event, a corneal abrasion, that was unrelated to device wear. Conclusions: Negative pressure application to the periocular space with a multi-pressure dial can produce titratable IOP reduction while the device is worn with active negative pressure. To our knowledge, this technology represents the first nonpharmacologic, nonlaser, nonsurgical method for IOP reduction. Translational Relevance: This represents the first study demonstrating the IOP-lowering ability of the multi-pressure dial, a device that uses a novel IOP-lowering strategy by delivering negative pressure to the periocular region.


Assuntos
Glaucoma de Ângulo Aberto , Pressão Intraocular , Anti-Hipertensivos/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Humanos , Estudos Prospectivos , Tonometria Ocular
7.
Ophthalmic Surg Lasers Imaging Retina ; 51(11): 633-639, 2020 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-33231696

RESUMO

BACKGROUND AND OBJECTIVE: Clinical trials in neovascular age-related macular degeneration (nAMD) demonstrate that high visual acuity (VA) can be maintained, and low VA can be improved with anti-vascular endothelial growth factor (VEGF) treatment. Few real-world data investigating the relationship between baseline VA and long-term outcomes exist. This study compares VA at diagnosis and after treatment using data from a large patient registry. PATIENTS AND METHODS: Retrospective study of IRIS Registry patients diagnosed with nAMD in one or both eyes between January 2013 and June 2017. Patients received at least two anti-VEGF injections in the study eye(s) less than 45 days apart during the study period. Primary outcomes were the percentage of eyes with 20/40 VA or better at diagnosis and association of VA at diagnosis with longer-term visual outcomes. RESULTS: The study included 162,902 eyes. Among all included eyes, 34.3% presented with 20/40 VA or better at diagnosis. Patients with 20/40 vision or better at baseline maintained a mean VA of 20/40 or better for 2 years after treatment initiation. CONCLUSIONS: Baseline VA at nAMD diagnosis predicts long-term VA outcomes. Early diagnosis before VA is adversely affected is a key factor in preserving vision in patients with nAMD. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:633-639.].


Assuntos
Ranibizumab , Acuidade Visual , Degeneração Macular Exsudativa , Inibidores da Angiogênese/uso terapêutico , Seguimentos , Humanos , Injeções Intravítreas , Ranibizumab/uso terapêutico , Sistema de Registros , Estudos Retrospectivos , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular , Degeneração Macular Exsudativa/diagnóstico , Degeneração Macular Exsudativa/tratamento farmacológico
8.
Ophthalmology ; 116(4): 691-701, 2009 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-19344821

RESUMO

PURPOSE: To analyze the patient reported outcome of satisfaction after LASIK surgery. DESIGN: Systematic review. PARTICIPANTS: Patient data from previously reported studies. METHODS: A literature search conducted for the years 1988 to 2008 that included pertinent LASIK surgery information from the review of 2915 retrieved citations. All abstracts from these citations were reviewed and 1581 were deemed to be relevant for review. Complete copies of each of these relevant (1581) articles were obtained, and after thorough analysis each was rated based on the strength of the study design and weight of evidence. A level I rating was assigned to properly conducted, well-designed, randomized clinical trials; a level II rating to well-designed cohort and case-control studies; and a level III rating to case series, case reports, and poorly designed prospective and retrospective studies. Level I and II rated, peer-reviewed articles were entered into a database, and level III articles were eliminated. A total of 309 articles were incorporated into this database, representing level I and level II well-controlled studies of primary LASIK surgery. MAIN OUTCOME MEASURES: Patients' satisfaction rates and factors associated with dissatisfaction. RESULTS: Nineteen of the 309 database articles (6.1%) reported on both patient quality of life and satisfaction and together encompassed a total of 2198 subjects. The procedures from these 19 articles took place between 1995 and 2003. The overall patient satisfaction rate after primary LASIK surgery was 95.4% (2097 of 2198 subjects; range of patient satisfaction for the 19 articles was 87.2%-100%). The patient satisfaction rate after myopic LASIK was 95.3% (1811 of 1901 patients), and after hyperopic LASIK was 96.3% (286 of 297 subjects). CONCLUSIONS: Based on this review, worldwide, an average 95.4% of patients were satisfied with their outcome after LASIK surgery. With 16.3 million procedures performed worldwide, and more than a decade of clinical studies and technological innovation, LASIK surgery should be considered among the most successful elective procedures. LASIK surgery compares more favorably with other elective surgical procedures in terms of generally higher satisfaction rates.


Assuntos
Hiperopia/cirurgia , Ceratomileuse Assistida por Excimer Laser In Situ , Miopia/cirurgia , Satisfação do Paciente/estatística & dados numéricos , Qualidade de Vida , Adolescente , Adulto , Idoso , Bibliometria , Saúde Global , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento
9.
Am J Ophthalmol ; 203: 78-88, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30849341

RESUMO

PURPOSE: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively. DESIGN: Cohort study within a multi-center, double-masked, randomized clinical trial. METHODS: 1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals). RESULTS: Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm2, P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD. CONCLUSIONS: Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.


Assuntos
Córnea/patologia , Edema da Córnea/cirurgia , Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior/métodos , Distrofia Endotelial de Fuchs/cirurgia , Rejeição de Enxerto/prevenção & controle , Pressão Intraocular/fisiologia , Preservação de Órgãos/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Contagem de Células , Edema da Córnea/diagnóstico , Método Duplo-Cego , Feminino , Seguimentos , Distrofia Endotelial de Fuchs/diagnóstico , Rejeição de Enxerto/diagnóstico , Sobrevivência de Enxerto , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
11.
J Cataract Refract Surg ; 34(5): 735-42, 2008 May.
Artigo em Inglês | MEDLINE | ID: mdl-18471626

RESUMO

PURPOSE: To evaluate the long-term effect of phacoemulsification with intraocular lens (IOL) implantation alone in normotensive and ocular hypertensive eyes. SETTING: Private practices, Minneapolis, Minnesota, and Savannah, Georgia, USA. METHODS: The IOP before surgery, 1 year after surgery, and at the final chart recording in 588 eyes having phacoemulsification with IOL implantation was retrospectively reviewed. Before surgery, eyes were divided into 5 groups based on IOP at surgery, patient age at surgery, years of postoperative follow-up, and a comparison between IOP at 1 year and IOP at the final check. RESULTS: The final mean IOP reduction was 6.5 mm Hg (27%) in the 31 to 23 mm Hg presurgical IOP group (n = 19), 4.8 mm Hg (22%) in the 22 to 20 mm Hg group (n = 62), 2.5 mm Hg (14%) in the 19 to 18 mm Hg group (n = 86), and 1.6 mm Hg (9%) in the 17 to 15 mm Hg group (n = 223). In the 14 to 9 mm Hg group (n = 198), the mean IOP at the final examination was 0.2 mm Hg higher (0.1% increase). CONCLUSIONS: Stratifying eyes according to presurgical IOP showed greater long-term IOP reductions than previously reported. The reduction was proportional to the presurgical IOP. The decrease was greatest in eyes with the highest presurgical IOP. The IOP remained unchanged in eyes with the lowest presurgical IOP. The IOP reductions at 1 year were sustained over 10 years and were similar in patients of all ages.


Assuntos
Pressão Intraocular/fisiologia , Implante de Lente Intraocular , Hipertensão Ocular/fisiopatologia , Facoemulsificação , Idoso , Idoso de 80 Anos ou mais , Seguimentos , Humanos , Estudos Retrospectivos , Tonometria Ocular
12.
Curr Pharm Des ; 23(4): 558-564, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-27897120

RESUMO

Risk reduction and the attainment of good outcomes in contemporary cataract surgery depend in part on patient compliance with a postoperative regimen of topical eye drops. Topical drops are expensive and challenging to instill properly for patients. The consequences of noncompliance or poor compliance can be significant for the patient (in the case of a complication) and for society (in the case of development of antibiotic resistance). For all of these reasons, new approaches that reduce the need for topical therapy are beginning to emerge, including intracameral injection, sustained or slow-release drug delivery mechanisms, and the recently introduced "Dropless cataract surgery," which involves intravitreal injection of single-use, compounded combination of antibiotics and corticosteroids. This paper is a review of the rationale for reducing topical therapy in cataract surgery prophylaxis, and what is known to date about the efficacy and safety of the dropless approach.


Assuntos
Corticosteroides/uso terapêutico , Antibacterianos/uso terapêutico , Antibioticoprofilaxia , Extração de Catarata/efeitos adversos , Soluções Oftálmicas/efeitos adversos , Complicações Pós-Operatórias/tratamento farmacológico , Corticosteroides/administração & dosagem , Antibacterianos/administração & dosagem , Preparações de Ação Retardada , Sistemas de Liberação de Medicamentos , Humanos , Injeções Intravítreas , Soluções Oftálmicas/uso terapêutico , Complicações Pós-Operatórias/cirurgia
14.
Clin Ophthalmol ; 10: 2311-2317, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27920490

RESUMO

PURPOSE: The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. METHODS: A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. RESULTS: At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. CONCLUSION: Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery.

15.
Clin Ophthalmol ; 10: 1495-503, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27570444

RESUMO

PURPOSE: To evaluate the clinical efficacy and safety of a 1% azithromycin-0.1% dexamethasone combination in DuraSite ("combination") compared to 0.1% dexamethasone in DuraSite, 1% azithromycin in DuraSite, and vehicle in the treatment of subjects with blepharitis. MATERIALS AND METHODS: This was a Phase III, double-masked, vehicle-controlled, four-arm study in which 907 subjects with blepharitis were randomized to combination (n=305), 0.1% dexamethasone (n=298), 1% azithromycin (n=155), or vehicle (n=149). Ten study visits were scheduled: screening visit, days 1 and 4 (dosing phase) and 15, and months 1-6 (follow-up phase). On day 1, subjects applied one drop of the study drug to the eyelid of the inflamed eye(s) twice daily, and continued with twice-daily dosing for 14 days. After completing 14 days of dosing, subjects were followed for 6 months for efficacy and safety. RESULTS: A total of 57 subjects (6.3%) had complete clinical resolution at day 15: 25 (8.2%), 17 (5.7%), 8 (5.2%), and 7 (4.7%) subjects in the combination-, 0.1% dexamethasone-, 1% azithromycin-, and vehicle-treatment groups, respectively. The combination was superior to 1% azithromycin and vehicle alone, but not to 0.1% dexamethasone alone. Mean composite (total) clinical sign and symptom scores improved in all four treatment groups during the post-treatment evaluation phase for the intent-to-treat population, but outcomes were superior when a drop containing 0.1% dexamethasone was utilized. Clinical response was noted as early as day 4, and persisted as long as 6 months. Most adverse events were considered mild in severity and not related to the study drug. CONCLUSION: A higher percentage of subjects in the combination group achieved complete clinical resolution of the signs and symptoms of blepharitis at day 15 than with 1% azithromycin and vehicle, but outcomes were similar to treatment with 0.1% dexamethasone alone. The combination was well tolerated.

16.
J Cataract Refract Surg ; 42(8): 1224-34, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27531300

RESUMO

UNLABELLED: Laser in situ keratomileusis (LASIK) articles published between 2008 and 2015 that contain clinical outcomes data were reviewed and graded for quality, impression, and potential bias. All 97 relevant articles (representing 67 893 eyes) provided a positive or neutral impression of LASIK. Industry bias was not evident. The aggregate loss of 2 or more lines of corrected distance visual acuity was 0.61% (359/58 653). The overall percentage of eyes with uncorrected distance visual acuity better than 20/40 was 99.5% (59 503/59 825). The spherical equivalent refraction was within ±1.0 diopter (D) of the target refraction in 98.6% (59 476/60 329) of eyes, with 90.9% (59 954/65 974) within ±0.5 D. In studies reporting patient satisfaction, 1.2% (129/9726) of patients were dissatisfied with LASIK. Aggregate outcomes appear better than those reported in summaries of the safety and effectiveness of earlier laser refractive surgery systems approved by the U.S. Food and Drug Administration. Modern results support the safety, efficacy, and patient satisfaction of the procedure. FINANCIAL DISCLOSURE: Proprietary or commercial disclosures are listed after the references.


Assuntos
Ceratomileuse Assistida por Excimer Laser In Situ , Miopia/terapia , Acuidade Visual , Humanos , Estudos Prospectivos , Refração Ocular , Estudos Retrospectivos , Resultado do Tratamento
17.
Ophthalmology ; 112(2): 278-85, 2005 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-15691564

RESUMO

PURPOSE: To determine the effects of Artisan lens implantation on contrast sensitivity. DESIGN: Prospective consecutive interventional case series. PARTICIPANTS AND CONTROLS: Forty-nine eyes of 30 patients with myopia and myopia with astigmatism, who underwent implantation of the Artisan iris-fixated phakic intraocular lens. Preoperative testing served as the control. INTERVENTION: Implantation of the Artisan phakic intraocular lens to correct myopia. MAIN OUTCOME MEASURES: Refractive predictability and Snellen visual acuity were evaluated preoperatively and at least 4 months postoperatively. Additionally, photopic and mesopic contrast sensitivities were measured at 1.5, 3, 6, 12, and 18 cycles per degree, with and without glare testing. RESULTS: The mean preoperative spherical equivalent (SE) was -12.16 diopters (D) (range, -6.88 to -18.00). The mean postoperative SE was -0.46+/-0.58 D (range, +0.50 to -1.75). Ninety percent of eyes were within 1.00 D of the predicted result, and 39% gained > or =1 lines of best-corrected visual acuity (BCVA). When compared with preoperative measurements, postoperative contrast sensitivity was increased under photopic conditions and slightly decreased under mesopic conditions. Adverse events were one wound leak requiring resuturing in the immediate postoperative period and one subluxed lens after significant blunt trauma. No eyes lost > or =2 lines of BCVA. CONCLUSIONS: Artisan implantation for the correction of high myopia seems to be a predictable procedure. Increases in photopic contrast sensitivity values after implantation of this phakic intraocular lens stand in distinction to the decreases in photopic contrast sensitivity previously reported after LASIK correction of this degree of myopia.


Assuntos
Sensibilidades de Contraste/fisiologia , Implante de Lente Intraocular/métodos , Miopia/fisiopatologia , Miopia/cirurgia , Adulto , Astigmatismo/fisiopatologia , Feminino , Ofuscação , Humanos , Iris/cirurgia , Cristalino/fisiologia , Lentes Intraoculares , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Acuidade Visual
18.
J Refract Surg ; 21(2): 148-51, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-15796219

RESUMO

PURPOSE: To determine whether the use of 70% isopropyl alcohol is useful as an adjunct to simple mechanical removal of epithelial ingrowth following laser in situ keratomileusis (LASIK). METHODS: A retrospective comparison of two techniques of epithelial ingrowth removal following LASIK was performed. A total of 38 procedures on 31 patients were included. In one group, the epithelium was removed using a simple mechanical scraping technique and in the other, a similar technique combined with the application of 70% isopropyl alcohol was used. The rates of recurrence in the two groups were compared using a chi-square analysis. RESULTS: The total incidence of epithelial ingrowth recurrence in both groups was 57.9% (22/38). The incidence of clinically significant ingrowth recurrence in both groups was 34.2% (13/38). In the scrape group, the recurrence of any ingrowth was 43.8% (7/16) and the recurrence of clinically significant ingrowth was 31.3% (5/16). In the alcohol group, these rates were 68.2% (15/22) and 36.4% (8/22), respectively. The difference between the two groups did not show statistical significance in either comparison (P=.14 and P=.75, respectively). CONCLUSIONS: The use of 70% isopropyl alcohol showed no additional benefit over simple mechanical scraping in the removal and prevention of epithelial ingrowth recurrence following LASIK.


Assuntos
2-Propanol/uso terapêutico , Doenças da Córnea/terapia , Desbridamento/métodos , Epitélio Corneano/efeitos dos fármacos , Epitélio Corneano/cirurgia , Ceratomileuse Assistida por Excimer Laser In Situ/efeitos adversos , Complicações Pós-Operatórias , Adulto , Doenças da Córnea/etiologia , Epitélio Corneano/patologia , Seguimentos , Humanos , Miopia/cirurgia , Recidiva , Reoperação , Estudos Retrospectivos , Fatores de Risco , Acuidade Visual
19.
J Refract Surg ; 19(6): 671-5, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-14640433

RESUMO

PURPOSE: To report two different cases of sterile, peripheral keratitis following laser in situ keratomileusis (LASIK). METHODS: A report of two cases (two eyes of two patients). RESULTS: In two patients, peripheral infiltrates appeared 1 day after LASIK. One patient had a history of rheumatoid arthritis and both had peripheral corneal changes that may have represented prior inflammatory events. The presentations were quite different, with one occurring in association with an epithelial defect at the edge of the flap and the other occurring without an epithelial defect peripheral to the microkeratome cut. In the second case a similar infiltrate showed up in the unoperated fellow eye. Both patients were treated with aggressive antibiotic and corticosteroid therapy. Both patients recovered well with no loss of best spectacle-corrected visual acuity. CONCLUSION: Peripheral keratitis can occur in patients following LASIK; preoperative evidence of previous inflammation may be a marker for patients at higher risk. Rheumatoid arthritis patients may be at increased risk for this complication. With careful and aggressive management excellent visual outcomes are still possible.


Assuntos
Córnea/patologia , Ceratite/etiologia , Ceratomileuse Assistida por Excimer Laser In Situ/efeitos adversos , Adulto , Antibacterianos , Artrite Reumatoide/complicações , Quimioterapia Combinada/uso terapêutico , Feminino , Glucocorticoides/uso terapêutico , Humanos , Ceratite/diagnóstico , Ceratite/tratamento farmacológico , Pessoa de Meia-Idade , Miopia/cirurgia
20.
J Refract Surg ; 19(6): 654-60, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-14640430

RESUMO

PURPOSE: To determine whether surgeon-specific nomogram adjustments are useful when using the Technolas 217A excimer laser for treating myopia and myopic astigmatism. METHODS: We conducted a prospective evaluation of 216 consecutive eyes with 6 months follow-up after treatment of myopia or myopic astigmatism with the Technolas 217A laser. Attempted vs. achieved change in refraction was analyzed with a statistical analysis software program. Factors such as age, corneal thickness (pachymetry), preoperative spherical equivalent refraction, preoperative cylinder, and optical zone were studied to evaluate their role in predicting refractive outcome at 6 months after LASIK. RESULTS: The mean value of attempted spherical equivalent refraction was -5.32 +/- 2.72 D. The mean achieved refractive correction at 6 months was -5.55 +/- 2.78 D, with a mean spherical equivalent of 0.13 +/- 0.54 D. The percent achieved effect at 1 month was 105%, and at 6 months, 103%. Preoperative spherical equivalent refraction and optical zone size were strong predictors of 6-month LASIK outcome. There was a 9% difference in the percent achieved effect between a 4 and 7-mm optical zone. There was no correlation between age, preoperative cylinder, or surgeon and 6-month outcome. CONCLUSIONS: Surgeons using the planoscan software on the Technolas 217A may experience a small initial overcorrection. There may be a benefit to reducing the treatment given with larger optical zones and smaller corrections.


Assuntos
Astigmatismo/cirurgia , Córnea/cirurgia , Ceratomileuse Assistida por Excimer Laser In Situ , Modelos Estatísticos , Miopia/cirurgia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Refração Ocular/fisiologia , Resultado do Tratamento
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