Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

OBJECTIVE: To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. METHODS: Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. RESULTS: A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. CONCLUSION: No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.

Biopharmaceutical industry-sponsored global clinical trials in emerging countries / Ensaios clínicos globais patrocinados pela indústria biofarmacêutica em países emergentes

OBJECTIVE: To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. METHODS: Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. RESULTS: A total of 8,501 trials were then active and 1,170 (13.8 percent) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. CONCLUSION: No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.

OBJETIVO: Avaliar ensaios clínicos patrocinados pela indústria biofarmacêutica alocados em países previamente definidos como emergentes em pesquisa clínica e possíveis diferenças naqueles alocados no Brasil. MÉTODOS: Dados de ensaios clínicos recrutando pacientes foram obtidos (www.clinicaltrials.gov) em 2 de fevereiro de 2009. As proporções de centros em cada país foram comparadas entre os países emergentes. Regressões logísticas múltiplas foram realizadas para avaliar a alocação do ensaio em outros países emergentes e as características do ensaio como preditores da presença de algum centro no Brasil RESULTADOS: No total, 8.501 ensaios clínicos estavam ativos à época, e 13,8 por cento destes (N=1.170) incluíam centros em países emergentes (i.e., Argentina, Brasil, China, República Tcheca, Hungria, Índia, México, Polônia, Rússia, Coreia do Sul, e África do Sul). Coreia do Sul e China apresentaram uma proporção de centros significativamente superior aos outros países (p<0,05). Não se detectou correlação negativa na alocação de ensaios no Brasil quando comparada com outros países. Ensaios envolvendo sujeitos com idade menor que 15 anos, com o recrutamento planejado de pelo menos 1.000 sujeitos e sete patrocinadores, foram identificados como preditores significativos da alocação de centros no Brasil. CONCLUSÃO: Não se detectou competição direta entre o Brasil e outro país emergente. A Coreia do Sul apresentou a maior proporção de centros e foi o terceiro país em número total de ensaios, demonstrando ser um importante país em termos de atratividade para ensaios clínicos patrocinados pela indústria biofarmacêutica.

Corneal graft survival after therapeutic keratoplasty for Acanthamoeba keratitis.

PURPOSE: To describe corneal graft survival and visual outcome after therapeutic penetrating keratoplasty in patients with Acanthamoeba keratitis (AK) that is unresponsive to clinical treatment. METHODS: Retrospective study. Thirty-two patients with AK who underwent therapeutic penetrating keratoplasty (tPK) from August 1996 to August 2005 were included. Data relating to clinical features, visual acuity, surgical technique, graft survival and complications were collected. Graft survival was evaluated by the Kaplan-Meier method and comparisons were performed using the Log-rank test. RESULTS: Most patients (62.5%) were female. Mean age [+/- standard deviation (SD)] was 35 (+/- 13) years (range 15-68 years). All patients were contact lens wearers. Eighteen patients (56%) presented paralytic mydriasis and glaucoma during the treatment. Thirteen patients (40%) developed glaucoma after surgery; eight of them (61%) required a second PK because of graft failure. Of the 32 keratoplasty eyes, 56.2% presented graft failure at any follow-up point. Forty-five per cent of graft failures occurred before the 12 month follow-up, so 55% remained clear in the first year after surgery. Twelve patients underwent a second PK; seven of them failed and 45% were clear at 1 year. Two patients presented graft recurrence of amoebic infection. There was no significant difference in graft survival when eyes with or without mydriasis were compared (P = 0.40). Eyes with glaucoma presented a significantly shorter graft survival (P = 0.01). CONCLUSION: Penetrating keratoplasty is a treatment option for eyes that are unresponsive to clinical treatment infections. However, graft survival is poor; postoperative glaucoma is frequent and is associated with shorter graft survival.

[Occupational trauma due to superficial corneal foreign body]. / Trauma ocupacional por corpo estranho corneano superficial.

PURPOSE: To evaluate the epidemiology of superficial corneal foreign body. METHODS: Patients who were seen at the Emergency Service of the Federal University of São Paulo, from April/05 to June/05, were screened and those with superficial corneal foreign body were interviewed. Data regarding gender, age, occupation, employment status, availability and use of protective devices and supervision of their use were collected. Awareness of the possible complications was also assessed. Results were analyzed using chi-square or Fisher exact test. RESULTS: One hundred twenty-three patients were interviewed. Only 3 patients were female. The mean age was 36 years. Most injuries occurred at the workplace (86.2%), and 58.4% of the patients did not have a legal employment registration. The occupational activities most frequently reported were construction related activities (44.3%) and welding/soldering (11.3%). In most workplaces (79.8%) protective devices were available and 85.3% of the patients were instructed to use them. A safety device was being used during the accident in 34.2% of the cases and this was more frequent among patients that had legal employment registry (p=0.008) and among those under supervision (p=0.0415). The majority of the patients (68.9%) were aware of the risk of severe complications. CONCLUSIONS: Most patients with superficial corneal foreign body are aware of its severe complications and injuries usually occur in places where safety devices are available and often during their use. Our findings suggest that prevention should focus on supervision and correct use of safety devices.

Trauma ocupacional por corpo estranho corneano superficial / Occupational trauma due to superficial corneal foreign body

OBJETIVO: Avaliar a epidemiologia do trauma ocular por corpo estranho superficial de córnea. MÉTODOS: Os pacientes atendidos no Pronto-Socorro da Universidade Federal de São Paulo entre abril e junho de 2005 que apresentaram corpo estranho superficial de córnea foram entrevistados. Foram avaliados: sexo, idade, profissão, registro legal do emprego, uso, disponibilidade e tipo de equipamentos de proteção utilizados e a fiscalização do seu uso. O conhecimento das complicações deste tipo de acidente também foi avaliado. Os resultados foram analisados com teste do qui quadrado ou teste de Fisher. RESULTADOS: Foram entrevistados 123 pacientes. Apenas 3 eram do sexo feminino e a idade média foi de 36 anos. A maioria destes traumas ocorreu no ambiente de trabalho (86,2 por cento) e 58,4 por cento não possuíam registro legal do emprego. As profissões mais freqüentemente envolvidas foram serralheiro, pedreiro e metalúrgico. Em 79,8 por cento dos locais de trabalho havia equipamentos de proteção e 85,3 por cento dos pacientes eram orientados a usá-los. Em 52,4 por cento dos locais sua utilização era fiscalizada, mas apenas 34,2 por cento usavam no momento do trauma. A utilização foi mais freqüente (p=0,008) e fiscalização mais presente (p=0,0415) entre pacientes com registro legal de emprego. Questionados sobre os riscos, 68,9 por cento dos pacientes tinham consciência das complicações graves deste tipo de acidente. CONCLUSÃO: A maioria dos pacientes tem conhecimento sobre a gravidade do trauma ocular e este tipo de lesão ocorre mesmo em locais com equipamentos de proteção disponíveis, alguns deles até durante o seu uso. Os dados sugerem que enfoque maior da prevenção deve ser na fiscalização e utilização de equipamentos adequados.

PURPOSE: To evaluate the epidemiology of superficial corneal foreign body. METHODS: Patients who were seen at the Emergency Service of the Federal University of São Paulo, from April/05 to June/05, were screened and those with superficial corneal foreign body were interviewed. Data regarding gender, age, occupation, employment status, availability and use of protective devices and supervision of their use were collected. Awareness of the possible complications was also assessed. Results were analyzed using chi-square or Fisher exact test. RESULTS: One hundred twenty-three patients were interviewed. Only 3 patients were female. The mean age was 36 years. Most injuries occurred at the workplace (86.2 percent), and 58.4 percent of the patients did not have a legal employment registration. The occupational activities most frequently reported were construction related activities (44.3 percent) and welding/soldering (11.3 percent). In most workplaces (79.8 percent) protective devices were available and 85.3 percent of the patients were instructed to use them. A safety device was being used during the accident in 34.2 percent of the cases and this was more frequent among patients that had legal employment registry (p=0.008) and among those under supervision (p=0.0415). The majority of the patients (68.9 percent) were aware of the risk of severe complications. CONCLUSIONS: Most patients with superficial corneal foreign body are aware of its severe complications and injuries usually occur in places where safety devices are available and often during their use. Our findings suggest that prevention should focus on supervision and correct use of safety devices.

[Preoperative evaluation and cataract surgery]. / Avaliação pré-operatória na cirurgia de catarata.

PURPOSE: Analysis of the relevance of preoperative evaluation to prevent adverse clinical events, pre- and postoperative, on cataract surgery. METHODS: The study includes 1254 patients submitted to cataract surgery at the Instituto da Catarata do Departamento de Oftalmologia da UNIFESP - EPM, in the period of Jan - Dec 2004. Data referring to the preoperative evaluation and adverse clinical events related to anesthesia/surgical procedure were retrospectively collected. RESULTS: Sixteen patients (1.2%) showed an adverse clinical event. Nine hundred thirty-six patients (74.6%) showed at least one altered examination. This factor, nevertheless, did not show any relation to the adverse clinical event (p=0.334). CONCLUSION: Concerning the studied series, the altered laboratory tests, electrocardiogram and/or thorax x-ray has no correlation with the adverse clinical events related to the anesthesia/surgical procedure.

Avaliação pré-operatória na cirurgia de catarata / Preoperative evaluation and cataract surgery

OBJETIVO: Analisar a relevância da avaliação pré-operatória na prevenção de eventos clínicos adversos per e pós-operatórios na cirurgia de catarata. MÉTODOS: Foram incluídos no estudo 1.254 pacientes submetidos à cirurgia de catarata no Instituto da Catarata do Departamento Oftalmologia UNIFESP-EPM, no período de jan-dez 2004. Dados referentes à avaliação pré-operatória e à ocorrência de eventos clínicos adversos relacionados ao procedimento anestésico/cirúrgico foram retrospectivamente coletados. RESULTADOS: Dezesseis pacientes (1,2 por cento) apresentaram evento clínico adverso. Novecentos e trinta e seis pacientes (74,6 por cento) apresentaram pelo menos um exame alterado, porém este fator não mostrou associação com a ocorrência de evento clínico adverso (p=0,334). CONCLUSÃO: Na série estudada a alteração de exames laboratoriais, eletrocardiograma e/ou radiografia de tórax não se correlacionou com a ocorrência de eventos clínicos adversos relacionados ao procedimento anestésico/cirúrgico.

PURPOSE: Analysis of the relevance of preoperative evaluation to prevent adverse clinical events, pre- and postoperative, on cataract surgery. METHODS: The study includes 1254 patients submitted to cataract surgery at the Instituto da Catarata do Departamento de Oftalmologia da UNIFESP - EPM, in the period of Jan - Dec 2004. Data referring to the preoperative evaluation and adverse clinical events related to anesthesia/surgical procedure were retrospectively collected. RESULTS: Sixteen patients (1.2 percent) showed an adverse clinical event. Nine hundred thirty-six patients (74.6 percent) showed at least one altered examination. This factor, nevertheless, did not show any relation to the adverse clinical event (p=0.334). CONCLUSION: Concerning the studied series, the altered laboratory tests, electrocardiogram and/or thorax x-ray has no correlation with the adverse clinical events related to the anesthesia/surgical procedure.

[LASIK interface fluid accumulation caused by glaucoma associated with herpetic keratouveitis: case report]. / Coleção fluídica na interface do LASIK causada por glaucoma secundário à ceratouveíte herpética: relato de caso.

Herpes simplex virus infection is a frequent cause of intraocular inflammation or anterior uveitis. Ocular hypertension is a common feature in herpetic keratouveitis. We describe a fluid accumulation and flap displacement in late postoperative period (28 months) of LASIK associated with ocular hypertension caused by herpetic keratouveitis. This finding supports the theory that flap attachment after LASIK is only partial and the virtual space remains indefinitely. The presence of ocular hypertension may lead to corneal edema and fluid accumulation in the interface.

Coleção fluídica na interface do LASIK causada por glaucoma secundário à ceratouveíte herpética: relato de caso / LASIK interface fluid accumulation caused by glaucoma associated with herpetic keratouveitis: case report

A infecção por Herpes simplex vírus (HSV) é causa freqüente de inflamação intra-ocular ou uveíte anterior. A hipertensão ocular é característica comumente observada nas ceratouveítes herpéticas. Neste relato descrevemos o acúmulo de fluido e descolamento do "flap" corneano da ceratomileusis, no pós-operatório tardio de LASIK (28 meses), associado a quadro hipertensivo ocular secundário a ceratouveíte herpética. Este achado corrobora a suposição que a cicatrização corneana após LASIK seja apenas parcial e o espaço virtual produzido pela ceratomileuisis permaneça indefinidamente. Condições de aumento excessivo da pressão intra-ocular podem causar edema corneano com acúmulo de fluido da interface.

Herpes simplex virus infection is a frequent cause of intraocular inflammation or anterior uveitis. Ocular hypertension is a common feature in herpetic keratouveitis. We describe a fluid accumulation and flap displacement in late postoperative period (28 months) of LASIK associated with ocular hypertension caused by herpetic keratouveitis. This finding supports the theory that flap attachment after LASIK is only partial and the virtual space remains indefinitely. The presence of ocular hypertension may lead to corneal edema and fluid accumulation in the interface.

Herpes zoster ophthalmicus in otherwise healthy children.

PURPOSE: To evaluate the complications of herpes zoster ophthalmicus (HZO) in children. DESIGN: Prospective-observational case series. METHODS: Ten healthy patients (five boys, five girls) with HZO were prospectively followed. Data regarding best-corrected visual acuity, biomicroscopy, intraocular pressure, corneal sensitivity, and funduscopy were collected. The median duration of follow-up was 19 months (range eight to 78 months). RESULTS: The mean age at presentation was 8.7 years (range two to 14 years +/-3.95). At last visit, two patients (20%) had decreased visual acuity and nine (90%) had some degree of abnormal corneal sensitivity and corneal opacity despite good final visual acuity. CONCLUSION: In general, HZO seems to have a good prognosis in healthy children; nonetheless, some cases can present severe eye complications causing visual loss.

Surgical monovision and monovision reversal in LASIK.

PURPOSE: This study was designed to assess the success of surgical monovision in presbyopic patients. METHODS: A university refractive surgery center retrospective chart review of 82 patients who elected to undergo surgical monovision with laser in situ keratomileusis (LASIK) between January 2000 and January 2003 was conducted. Specific factors included for analysis included preoperative and postoperative defocus spherical equivalent, whether the patient underwent enhancements, whether the patient underwent a preoperative monovision trial with contact lens, and whether the patient underwent monovision reversal. RESULTS: Eighty-two patients who underwent LASIK for monovision were analyzed. Mean preoperative spherical equivalent in the distance-corrected eye was -4.07 (standard deviation (SD), 2.49); for the eye corrected for near vision, mean preoperative spherical equivalent was -4.10 (SD, 2.56). Postoperative spherical equivalent in the distance eyes was -0.01 (SD, 0.38) and in the near eyes -1.24 (SD, 0.91). There were 6 enhancements in the near eyes (7%) and 17 enhancements in the distance vision eyes (21%). This difference was statistically significant (P = 0.007). Thirty patients underwent a contact lens trial of monovision before LASIK, and none of those patients elected monovision reversal. There were 52 patients who did not undergo a contact lens monovision trial before LASIK monovision, and 2 of these patients underwent monovision reversal. Monovision success in this population was 97.6%. CONCLUSION: Surgical monovision can help presbyopic patients achieve their goal of reduced dependence on spectacles. A trial of monovision contact lenses or spectacles may be important in helping surgeons select patients for successful surgical monovision.

Wavefront analysis in Asian-Brazilians.

PURPOSE: To compare the distribution of ocular higher order wavefront aberrations (third to sixth order) in the Brazilian population of Asian and non-Asian refractive surgery patients. METHODS: Preoperative refractive and wavefront data were reviewed for 648 eyes in 324 patients who underwent custom ablation at the Excimer Laser Santa Cruz refractive surgery center in São Paulo, Brazil, from March 2002 to July 2005. Patients were divided into two groups: Asian patients and non-Asian patients, based on family history. Statistical analysis was performed to assess the differences between the groups with respect to manifest refractive spherical equivalent, astigmatism, pachymetry, OPD-root-square-mean (RMS) for a 6.0-mm pupil, total wavefront aberrations, third- to sixth-order higher order aberrations, and individual aberrations. RESULTS: The mean spherical equivalent refraction in the Asian group of -4.38 diopters (D) was significantly higher than the spherical equivalent refraction of -3.46 D in the non-Asian group (t= -4.32; P=.00001). Comparison of the differences between groups with respect to higher order aberrations, coma, trefoil, quadrafoil, spherical aberration, higher order astigmatism, and pachymetry was not statistically significant. CONCLUSIONS: Asian patients have a higher prevalence of myopia than non-Asian patients. No differences were noted in higher order aberrations between Asian and non-Asian patients.

Glycomics analyses of tear fluid for the diagnostic detection of ocular rosacea.

A Glycomics approach to detect disease is illustrated in the analyses of human tear fluid for rosacea. The diagnosis of ocular rosacea is particularly challenging in a subgroup of patients that do not present with typical facial skin findings but have ocular signs and symptoms. Indeed, up to 90% of patients with ocular rosacea may have neither obvious roseatic skin changes nor a previous diagnosis of rosacea. Tear fluid was collected from 37 subjects (21 controls and 16 patients with ocular rosacea) after conjunctival stimulation with filter (Schirmer) paper. O-linked oligosaccharides were released from tear fluid by beta-elimination and then purified using solid-phase extraction. Mass spectra were recorded on an external source HiResMALDI with a 7.0 T magnet. Mass spectra were obtained in both the positive and negative modes. However, signals were stronger in the negative mode. Tear fluid samples from rosacea patients yielded distinctive clusters of peaks that extend to higher masses. Patients with rosacea presented several oligomeric series that were not found in the controls. To discriminate the ocular rosacea cases from the normal controls, the sum of absolute intensities of 13 series corresponding to nearly 50 identified mass spectrum peaks was used. Thirty-six out of the 37 samples were correctly classified. This yields a sensitivity of 100% (95% CI 79.5-100) and specificity of 95.2% (95% CI 76.2-99.9). The high abundance of oligosaccharides in the tear fluid of patients with rosacea may lead to an objective diagnostic marker for the disease.

Deep stromal mycobacterial keratitis: viable bacteria after six months of treatment: case report and literature review.

To report the presence of viable mycobacteria in a patient with keratitis treated for 6 months. Species identification was performed using the PRA method (polymerase chain reaction followed by restriction endonuclease analysis). Clonality was evaluated with RAPD (randomly amplified polymorphic DNA) and ERIC-PCR (enterobacterial repetitive intergenic consensus-polymerase chain reaction) methods. The patient reported trauma due to a metallic foreign body 3 weeks prior to presentation. Initial corneal scraping cultures revealed Mycobacterium abscessus. After 6 months of topical and systemic treatment the patient presented with no active inflammation and was considered clinically cured. An optic penetrating keratoplasty was performed. Culture of the excised cornea revealed Mycobacterium abscessus. Both isolates had the same clonal origin. The most interesting finding of this case report was the positive culture of the excised cornea after 6 months of intensive specific topical therapy. To our knowledge, this is the first report in the literature showing this possibility in the treatment of Mycobacterial keratitis. Thus, Mycobacterium abscessus may present viable bacteria after long-term treatment and should be followed carefully for a long period of time after tapering the medication.

Factors modulating p63 expression in cultured limbal epithelial cells.

PURPOSE: The expression pattern of p63, a homologue of the transcription factor p53, and whether it can be used as a corneal epithelial stem cell specific marker remain controversial. We investigated the p63 expression pattern in cultured limbal epithelial cells at different time points in culture, in sparse and confluent cultures, after growth factor starvation, and in single-cell-derived colonies. METHODS: Harvested limbal epithelial cells were plated at 2.5 (sparse) or 5 (dense) x 10 cells/cm and evaluated for p63 expression at day 1, day 4, day 7, after starvation for 72 hours, or in colonies derived from single cells. Expression of corneal lineage specific differentiation marker keratin 3 (K3) was correlated with p63 expression. Results were compared by 1-way ANOVA. RESULTS: More than 85% (85%-90%) of cells expressed p63 on day 1 regardless of cell plating density. On day 4, sparsely plated cultures were subconfluent and demonstrated high p63 expression (87.4%), whereas densely plated cells were confluent and had markedly reduced p63 expression (16.9%). Starvation of subconfluent cultures arrested cell division but did not decrease p63 expression. High-p63-expressing cultures expressed low levels of K3, and this trend was reversed in confluent cultures. Most cells in all colonies derived from single cells expressed p63. CONCLUSIONS: The majority of corneal limbal epithelial cells express p63 in colonies derived from single cells and in subconfluent cultures regardless of time in culture or continuance of cell division. This suggests that p63 expression in culture cannot be used as a marker for stem cells. Significantly reduced number of cells express p63 in confluent cultures, associated with increased cell-cell contact. It is notable that these cells continue to express p63 amid areas of increased cell-cell contact several days after cultures have attained full confluency. This may represent a unique subpopulation of cells that retain proliferative potential in a confluent culture and may be analogous to a subpopulation of stem cells present in vivo.

Deep stromal mycobacterial keratitis: viable bacteria after six months of treatment: case report and literature review

O objetivo do caso é descrever a presença de micobactérias viáveis em pacientes com ceratite, 6 meses após tratamento intensivo. A identificação de espécies, foi efetuada usando método PRA (polymerase chain reaction seguida pela restriction endonuclease analysis). Clonalidade foi avaliada pelos métodos RAPD (randomly amplified polymorphic DNA) e ERIC-PCR (enterobacterial repetitive intergenic consensus - polymerase chain reaction). Paciente refere trauma com corpo estranho metálico há 3 semanas. A cultura da córnea revelou Mycobacterium abscessus. Após 6 meses de tratamento tópico e sistêmico, paciente apresentava-se sem inflamação, sendo considerado clinicamente curado. Realizou-se então, uma ceratoplastia penetrante com intuitos ópticos. A cultura da córnea transplantada revelou micobactérias de mesma origem clonal. O achado mais interessante neste relato, foi a positividade da cultura da córnea transplantada após 6 meses de intenso tratamento específico. Ao nosso conhecimento, esse é o primeiro caso relatado na literatura mostrando essa possibilidade em tratamento de ceratites por micobactérias. Assim, os pacientes com ceratite por Mycobacterium abscessus podem apresentar bactérias viáveis após longo tempo de tratamento específico e precisam ser seguidos cuidadosamente por um longo período de tempo.

Ocular rosacea.

Rosacea is a common skin disease that frequently involves the eye. Although the pathogenesis of the disease remains undefined, recent findings suggest that an altered inflammatory response plays an important role in both cutaneous and ocular rosacea. Ocular manifestations include lid and ocular surface alterations. Chronic inflammation can lead to corneal vascularization, which may compromise vision. Treatment of ocular rosacea is aimed at preventing irritation of the ocular surface (e.g., lubricants, lid hygiene) and controlling inflammation with topical and systemic anti-inflammatory drugs. Systemic tetracyclines are the mainstay of treatment. These drugs act multifactorially by decreasing bacterial flora and the expression of matrix metalloproteinases, altering meibum secretion, inhibiting the production of bacterial lipases, and providing an immunomodulatory effect.

Intraoperative microkeratome complications in 47,094 laser in situ keratomileusis surgeries.

PURPOSE: We evaluated the incidence and intraoperative microkeratome-related complications in laser in situ keratomileusis (LASIK). METHODS: We present non-randomized, retrospective, comparative, interventional case series. We reviewed the records of patients who underwent LASIK from August 2000 to March 2004 at Excimer Laser Santa Cruz, São Paulo, Brazil (47,094 eyes). We identified 369 eyes (0.0078%) with an intraoperative complication. Data were collected regarding microkeratome, average keratometric power, and type of complication. RESULTS: The Hansatome microkeratome was the most common microkeratome used (34,182 eyes; 73%), followed by the Automated Corneal Shaper-ACS (11,164 eyes, 24%) and the Nidek MK-2000 (1748 eyes, 3.7%). Intraoperative complications were more common with the ACS (1.26%) than with the Hansatome (0.63%) and MK-2000 (0.63%) (P<.001; P=.03; respectively). Complications included incomplete flaps (0.23%), buttonholes (0.13%), thin flaps (0.08%), and free flaps (0.08%). Buttonholes were more frequent with the ACS (0.34%) than with the Hansatome (0.06%) (P<.001) and free flaps were more common with the ACS (0.20%) and MK-2000 (0.29%) than with the Hansatome (0.04%) (P<.001). Keratometric power of eyes with intraoperative complications was significantly higher in the ACS group compared to the Hansatome group. CONCLUSIONS: Intraoperative complications were more common with the ACS than with the Hansatome or MK-2000. Buttonholes were most frequent with the ACS, and the Hansatome had the lowest incidence of free flaps.

The long-term results of keratoplasty in eyes with a glaucoma drainage device.

PURPOSE: To study the outcome of penetrating keratoplasty (PK) in eyes with a glaucoma drainage device (GDD). DESIGN: Retrospective case-controlled study. METHODS: We reviewed all patients who underwent PK from December 1986 to September 2002 at the University of California, Davis (n = 1,974). We identified 33 patients (40 grafts) who were treated with a GDD and followed up for 6 months or more after PK. Graft survival and glaucoma control were compared with grafts in patients without glaucoma (n = 40) and patients with medically controlled glaucoma (n = 17). Kaplan-Meier survival analysis, log rank test, repeated-measures analysis of variance (ANOVA), Fisher exact test, and chi(2) were used in group comparisons. Multivariate analysis was performed using the Cox proportional hazards model. RESULTS: The percentages of clear grafts in the glaucoma drainage device group were 58.5% and 25.8% at 1 and 2 years, respectively. At these time points, glaucoma was controlled in 74.0% and 63.1% of the eyes, respectively. Both medically controlled glaucoma patients and nonglaucomatous patients had higher graft survival percentages at comparable time points. The presence of a GDD was an important factor influencing graft survival (Hazard ratio = 6.8). CONCLUSION: A GDD implant is an independent risk factor for graft failure. Although these devices are effective in controlling intraocular pressure (IOP) in the majority of eyes in the presence of PK, corneal graft clarity is often compromised.

Anterior stromal puncture in Brown-McLean syndrome.

We describe 2 cases of Brown-McLean syndrome with corneal edema successfully treated by anterior stromal puncture (ASP). Ophthalmologic examinations showed peripheral edema and aphakia in both patients. The patients had ASP to control the severe foreign-body sensation. The procedure was effective over a long-term follow-up, suggesting that peripheral ASP may be an effective therapeutic option for patients with symptomatic Brown-McLean syndrome.