A Retrospective Comparison of Ahmed Glaucoma Valve Implants with or without Ologen Collagen Matrix.

Purpose: To study the effects of Ologen collagen matrix on the outcomes of the Ahmed glaucoma valve implant. Study Design: Retrospective case-control multicenter study, conducted at four centers, comparing the 6-month outcomes of Ahmed valve implants with or without Ologen. Participants: The study included 125 eyes in a 4:1 pairing (25 patients with Ologen matched to 100 patients without Ologen). Intervention: Ologen was placed over the Ahmed plate in the study group. Success was defined as an intraocular pressure (IOP) ≤ 21 mmHg either with no medication (complete success) or regardless of medications (qualified success). Other outcomes included IOP variation, eye drop use, and surgical complications. Results: Overall, the IOP decreased from 30.72 ± 9.08 to 16.14 ± 4.79 mmHg (p=0.0001). Of the 125 eyes, 26 achieved complete success and 94 achieved qualified success. There was no difference in complete success between the groups (p=0.12); however, there was a difference in qualified success (p=0.01), with better results in the no-Ologen group (80% vs 56%). There were no differences in the decrease in medications (p=0.06), as well as the incidence of complications (p=0.69). Although the need for postoperative surgical reintervention was higher in the no-Ologen group (13% vs 4%), the difference was not significant (p=0.2). Conclusion: The reductions in IOP and number of medications were similar in both groups after 6 months, with similar complication rates. The qualified success rate was lower in the Ologen group, but further studies are needed to clarify the role of Ologen in Ahmed valve implants.

Retinal function after intravitreal injection of autologous bone marrow-derived mesenchymal stromal cells in advanced glaucoma.

PURPOSE: To report electroretinographic (ERG) findings in advanced glaucoma treated with a single intravitreal injection of bone marrow-derived mesenchymal stem cells (MSCs). METHODS: Intravitreal injection of autologous MSCs (1 × 106 cells) was performed in 2 eyes from 2 patients with open-angle glaucoma in advanced stage of optic neuropathy (ClinicalTrials.gov, NCT02330978, 01.05.2015): cup/disk ratio worse than 0.9, visual field mean deviation index lower than - 15 dB, visual acuity of light perception, but controlled intraocular pressure. ERG tests were recorded at baseline and week 1, 4 and 48 after injection, using DTL electrodes following the ISCEV standard: After dark adaptation, ERG was elicited using white flashes of 0.01 cd.s/m2 and 3.0 cd.s/m2, followed by 10-min light adaptation (30 cd/m2) and stimuli of 3.0 cd.s/m2 and 30 Hz flicker. RESULTS: Patients did not show improvement on visual acuity or visual field after treatment. At baseline, ERG responses showed typical findings for advanced glaucoma, with a- and b-wave amplitude and latency within normative range, but reduced photopic negative responses. No noteworthy changes were observed on ERG responses for both cases up to 1 week after treatment, but at day 15, one patient showed retinal detachment with proliferative vitreoretinopathy and was removed from the trial. The other patient kept ERG responses stable throughout study period. CONCLUSION: Although no ERG response changes were observed after MSCs injection in one case, the complication observed on the second one, along with the lack of visual function improvement, warrants further studies involving modified MSCs to treat ocular disorders, including glaucoma. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02330978- missed in pdf.

Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆.

PURPOSE: Many patients with open-angle glaucoma eventually require >2 medications to lower their intraocular pressure (IOP). Fixed-combination ophthalmic solutions can be advantageous in patients who require multiple medications, but the number of fixed combinations combining 3 complementary IOP-lowering agents remains limited. This study assessed the efficacy and safety of a triple fixed combination (TFC) of bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), compared with a dual fixed combination (DFC) of brimonidine 0.2%/timolol 0.5%. METHODS: Patients with a baseline IOP of 23-34 mm Hg in both eyes and no history of IOP-lowering procedures were eligible for participation in this multicenter, double-masked, randomized, Phase III study. After washout of previous treatment (if applicable), patients were randomized to receive TFC or DFC twice daily in each eye for 3 months. The primary efficacy variable was the change from baseline in mean IOP in the worse eye at week 12 in the modified intent-to-treat (mITT) population. TFC was superior to DFC if the treatment difference (TFC - DFC) favored TFC at week 12 (P ≤ 0.05; 2-sample t test). Secondary and sensitivity analyses were also performed. Safety, including adverse events, was assessed at all visits. FINDINGS: The mITT/safety population included 185 patients (TFC, n = 90; DFC, n = 95). TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 (week 12 treatment difference: ─2.17 mm Hg; 95% CI, ─3.12 to ─1.22). While treatment-related conjunctival hyperemia was more frequent with TFC than with DFC (47.8% vs 23.2%; P < 0.001), consistent with the additional presence of bimatoprost in TFC, most cases were mild and the numbers of patient discontinuations at week 12 were similar between the TFC and DFC groups (11 [12.2%] vs 7 [7.4%] patients; P = 0.266). No unexpected adverse events were reported. IMPLICATIONS: Compared with DFC, TFC provided superior IOP lowering throughout the primary efficacy period. An acceptable tolerability profile was observed through 12 months of use of TFC, offering an effective therapeutic option in patients with POAG or OHT who require multiple medications to control their IOP. Additional studies are required for the assessment of the long-term effects of TFC. ClinicalTrials.gov identifier: NCT01217606.

Spatial correlation between localized decreases in exploratory visual search performance and areas of glaucomatous visual field loss.

BACKGROUND: Visual search is a critical skill for several daily tasks and may be compromised in patients with impaired vision. The objective of this study was to study the relationships between exploratory visual search performance (EVSP) visual field (VF) sensitivity in patients with glaucoma. METHODS: Primary open-angle glaucoma patients (POAG; n = 29) and healthy (Control; n = 28) individuals with best corrected visual acuity better than 0.2 logMAR underwent a comprehensive ophthalmological examination, including Humphrey VF tests (24-2 SITA-Standard), and a monocular exploratory visual search digit-based task performed using a software that quantifies the time spent to find a targert on a random array of digits distributed on nine sequential screens. The screens were divided into five areas to topographically match with five VF sectors. RESULTS: As expected, POAG eyes had worse VF mean deviation (MD) sensitivity and EVSP than Controls (MD - 8.02 ± 7.88 dB vs - 1.43 ± 1.50 dB, p < 0.0001; and total EVSP time 106.42 ± 59.64 s vs 52.75 ± 19.07 s, p < 0.0001). MD sensitivity of both groups significantly correlated with total EVSP time (POAG r = - 0.45, p = 0.01; and Control r = 0.37, p = 0.049). A significant relationship was observed between EVSP (individual time) and both visual acuity (p = 0.006) and glaucoma diagnosis (p = 0.005). The mean sensitivity of the peripheral VF areas of the POAG group showed significant correlation with the individual search time in the corresponding spatial areas, except in the peripheral superior temporal area (r = - 0.35, p = 0.06). CONCLUSION: These data indicate that POAG patients' EVSP is impaired in topographically-correspondent VF areas with sensitivity loss. Visual search may be considered as a measure of impairment of daily activities in glaucoma patients, if further similar tests using binocular conditions corroborate our findings.

Safety and feasibility of the use of a bevacizumab-methylcellulose mixture as an adjunct to glaucoma surgery: a pilot study.

Bevacizumab, a monoclonal anti-vascular endothelial growth factor antibody, has been suggested as a potential healing therapeutic following glaucoma surgery. Here, we aimed to improve the bioavailability of bevacizumab when used as an adjunct therapy to non-penetrating deep sclerectomy (DS) by using a bevacizumab-methylcellulose mixture (BMM). Ten previously non-operated eyes in ten patients diagnosed with primary open angle glaucoma underwent DS with a subconjunctival injection of 0.3 ml of BMM (bevacizumab 3.75 mg incorporated into 4% methylcellulose) at the surgical site. Bevacizumab release was evaluated in vitro using size-exclusion high performance liquid chromatography (HPLC). Intraocular pressure (IOP), bleb morphology, corneal endothelial cell count (CECC), and complications were evaluated at 6 months after surgery. Using HPLC, bevacizumab was detected in BMM for up to 72 h. Moreover, all surgical blebs remained expanded with hyaline material during the first week. A significant IOP reduction (mean ± SD= -10.3 ± 5.4 mmHg, P<0.001) and diffuse blebs were observed at the final follow-up period. Although CECC was slightly reduced (-7.4%), no complications were observed. In conclusion, bevacizumab was released from BMM, and the use of this innovative mixture yielded good results following DS with no complications. Further studies are required to determine its efficacy prior to establishing BMM as an adjunct treatment for penetrating and non-penetrating glaucoma surgeries.

Safety and feasibility of the use of a bevacizumab-methylcellulose mixture as an adjunct to glaucoma surgery: a pilot study / Segurança e viabilidade do uso de uma mistura de bevacizumabe-metilcelulose como terapia adjuvante à cirurgia anti-glaucomatosa: um estudo piloto

ABSTRACT Bevacizumab, a monoclonal anti-vascular endothelial growth factor antibody, has been suggested as a potential healing therapeutic following glaucoma surgery. Here, we aimed to improve the bioavailability of bevacizumab when used as an adjunct therapy to non-penetrating deep sclerectomy (DS) by using a bevacizumab-methylcellulose mixture (BMM). Ten previously non-operated eyes in ten patients diagnosed with primary open angle glaucoma underwent DS with a subconjunctival injection of 0.3 ml of BMM (bevacizumab 3.75 mg incorporated into 4% methylcellulose) at the surgical site. Bevacizumab release was evaluated in vitro using size-exclusion high performance liquid chromatography (HPLC). Intraocular pressure (IOP), bleb morphology, corneal endothelial cell count (CECC), and complications were evaluated at 6 months after surgery. Using HPLC, bevacizumab was detected in BMM for up to 72 h. Moreover, all surgical blebs remained expanded with hyaline material during the first week. A significant IOP reduction (mean ± SD= -10.3 ± 5.4 mmHg, P<0.001) and diffuse blebs were observed at the final follow-up period. Although CECC was slightly reduced (-7.4%), no complications were observed. In conclusion, bevacizumab was released from BMM, and the use of this innovative mixture yielded good results following DS with no complications. Further studies are required to determine its efficacy prior to establishing BMM as an adjunct treatment for penetrating and non-penetrating glaucoma surgeries.

RESUMO O bevacizumabe (um agente anti-fator de crescimento endotelial vascular) tem sido sugerido como potencial modulador cicatricial na cirurgia do glaucoma. Este estudo objetivou melhorar a biodisponibilidade do bevacizumabe, investigando a viabilidade de uma nova mistura de bevacizumabe-metilcelulose (BMM) como terapia adjuvante para a esclerectomia profunda não-penetrante (DS). Dez olhos sem cirurgias prévias de 10 pacientes com glaucoma primário de ângulo aberto foram submetidos à DS associada à uma injeção subconjuntival de 0,3 ml da mistura de bevacizumabe-metilcelulose (bevacizumabe 3,75 mg incorporado em metilcelulose 4%) no sítio cirúrgico. A liberação de bevacizumabe foi avaliada in vitro através de cromatografia líquida de alta performance por exclusão de tamanho (HPLC). A pressão intraocular (PIO), a morfologia da ampola de filtração, a contagem de células endoteliais da córnea (CECC) e as complicações foram estudadas aos seis meses de seguimento. O bevacizumabe foi detectado a partir da mistura de bevacizumabe-metilcelulose por meio do HPLC até 72 horas. Além disso, todas as ampolas cirúrgicas permaneceram expandidas com material hialino durante a primeira semana. Uma redução significativa da pressão intraocular (média ± DP= -10,3 ± 5,4 mmHg, P<0,001) e ampolas difusas foram observadas ao final do período de seguimento. Embora a contagem de células endoteliais da córnea se mostrou discretamente diminuída (-7,4%), nenhuma complicação foi observada. Neste estudo, o bevacizumabe foi liberado da mistura de bevacizumabe-metilcelulose e o uso desta nova mistura se associou com bons resultados cirúrgicos e nenhuma complicação. Estudos futuros serão necessários para determinar sua eficácia, antes de se estabelecer a mistura de bevacizumabe-metilcelulose como um tratamento adjuvante às cirurgias penetrantes e não-penetrantes para o glaucoma.

Hyperemia reduction after administration of a fixed combination of bimatoprost and timolol maleate to patients on prostaglandin or prostamide monotherapy.

OBJECTIVE: The aim of this study was to evaluate the change in hyperemia and intraocular pressure (IOP) in patients who switch from prostaglandin or prostamide to a fixed combination of prostamide and timolol maleate. DESIGN: A multicenter, longitudinal, noncontrolled, nonrandomized open trial was conducted. PARTICIPANTS: One hundred forty-four patients (282 eyes) were selected: 60 (41.6%) were on travaprost, 51 (35.4%) on bimatoprost, and 33 (22.9%) on latanoprost. All patients included were unable to attain adequate IOP control with monotherapy and had no contraindications to ß-blockers. INTERVENTION: Patients were treated with a fixed combination of bimatoprost and timolol maleate. Hyperemia was evaluated using a referential table, and IOP was measured at 8:00, 12:00, and 16:00 h both before and after 4 months of treatment. MAIN OUTCOME: IOP and hyperemia were compared at 2 time points: pretreatment and after 4 months. The mean of the 3 IOP measurements taken at various points during the day was considered for analysis. Generalized estimating equations were used for repeated measures and intereye dependency adjustments. RESULTS: Hyperemia and IOP were reduced in all 3 groups, with the same pattern for both eyes. The bimatoprost group had the highest levels of hyperemia before treatment when compared with the latanoprost as well as the travaprost group and had the greatest reduction in hyperemia after treatment (P < 0.01). Regarding IOP, all 3 groups had a significant reduction (P < 0.001), but the bimatoprost group had a lower pretreatment IOP when compared with the travaprost and latanoprost groups. CONCLUSION: A significant reduction in hyperemia was found after switching from monotherapy with prostaglandins or prostamide to a fixed combination of prostamide and a ß-blocker. IOP reduction was significant after the intervention in all 3 groups.

Influencia da idade, espessura central da cornea e do indice de qualidade na tonometria de contorno dinamico / Influence of age, central corneal thickness, and quality score on dynamic contour tonometry

Os objetivos deste trabalho são comparar a pressão intra-ocular (PIO), medida com tonometria de contorno dinâmica (TCD) e tonometria de aplanação de Goldmann (TAG), analisar a influência da espessura central da córnea (ECC) e idade, em ambas as medições, bem como a influência do índice de qualidade sobre as leituras da TCD. Foram avaliados 500 indivíduos saudáveis (1000 olhos), sem história prévia de glaucoma ou hipertensão ocular (idade: 7 a 86 anos) recrutados consecutivamente. TAG, TCD e ECC foram obtidos de ambos os olhos de cada indivíduo, nessa ordem, por três observadores. A média de cinco medidas da ECC foi utilizada para análise. As medições da TCD foram aceitas quando o escore de qualidade variou entre 1 (qualidade superior) e 3 (menor qualidade). A média das PIOs obtidas com TCD foram superiores em 3,2 mmHg às medições com TAG. A análise de Bland-Altmann revelou má concordância entre as leituras de TCD e TAG, com intervalos de confiança de 95% de ± 6,98 mmHg. Os valores da ECC variaram entre 449 e 653 μm. As PIOs medidas com TAG...

The purposes of this study are to compare the IOP measurements obtained with dynamic contour tonometry (DCT) and Goldmann applanation tonometry (GAT), and to analyze the influence of central corneal thickness (CCT) and age on both measurements, and the influence of the quality score on DCT readings. 500 healthy subjects with no previous history of glaucoma or ocular hypertension (ages: 7 to 86 years old) were consecutively recruited. GAT (Haag Streit R900, Switzerland), DCT (SMT Swiss Micro Technology, Switzerland), and CCT (Sonomed Micropach 200P+, USA) measurements were obtained from both eyes of each individual, in this order, by three observers. The mean of five CCT measurements was used for analysis. DCT measurements were accepted when quality scores varied between 1 (higher quality) and 3 (lower quality). In our series, the mean DCT measurements were 3.2 mmHg higher than GAT readings. CCT values varied between 449 and 653 um.IOP measured by GAT...

Conhecimentos sobre prevenção e tratamento de glaucoma entre pacientes de unidade hospitalar / Knowledge on glaucoma prevention and treatment of patients in a hospital unit

OBJETIVO: Verificar conhecimentos de pacientes portadores de glaucoma em relação a sua afecção, com a finalidade de obter subsídios para auxiliar a relação médico-paciente e estimular a observância do tratamento. MÉTODOS: No Hospital do Servidor Público Estadual do município de São Paulo, Brasil, foi realizado estudo transversal analítico aplicando-se questionário estruturado, com base em estudo exploratório e submetido a teste prévio para avaliação do nível conhecimento em relação ao glaucoma. A variável "auto-avaliação do conhecimento" foi mensurada por escala ordinal (sabe bem, sabe mais ou menos, sabe mal e nada sabe). RESULTADOS: A população foi constituída por 405 pacientes portadores de glaucoma; 72,6 por cento do sexo feminino; idade média 66,2 anos; 54,3 por cento cursaram até o ensino fundamental. Os resultados revelaram: dos que sabem bem sobre o controle da doença, 95, 8 por cento declararam terem recebido explicações (p < 0,000); houve maior proporção (46,9 por cento) de pacientes que afirmaram "saber mais ou menos" quando comparado com os demais grupos, porém aqueles com maior escolaridade referiram maior conhecimento quando comparado aos com menor escolaridade (p < 0, 000); em relação às fontes de informação sobre glaucoma 49,9 por cento mencionaram unicamente o oftalmologista. CONCLUSAO: O conhecimento dos pacientes em relação ao glaucoma foi relacionado às explicações recebidas e ao nível de escolaridade. Este estudo confirma a necessidade da manutenção de orientações, divulgação continuada de informações sobre prevenção e tratamento de glaucoma, nos consultórios e na comunidade, para melhora do prognóstico visual.

Estudo comparativo dos resultados das provas da prono-posiçäo em quarto escuro em indivíduos sentados e em decúbito horizontal ventral / Comparative analysis of the results of dark room prone provocative test of patients in sitting and ventral decubitus positions

Objetivo: Investigar os resultados das provas de prono-posiçäo em quarto escuro (PPQE) em indivíduos sentados e em decúbito horizontal ventral. Material e Métodos: Foram estudados 30 olhos de 15 pacientes portadores de glaucoma. As provas da PPQE foram realizadas nas duas posiçöes (sentado e deitado) com intervalo de 24 horas. Resultados: A média e o desvio padräo da diferença entre as pressöes intra-oculares finais e iniciais, do olho direito na posiçäo sentado foi de 4.13 ñ 1.77 mmHg e na posiçäo de decúbito horizontal ventral foi de 4.40 ñ 1.69 mmHg. No olho esquerdo na posiçäo sentado foi 4.13 ñ 1.69 mmHg e na posiçäo de decúbito horizontal ventral foi de 4.47 ñ 2.07 mmHg. Conclusäo: Näo foram encontradas diferenças estatísticamente significantes, entre as posiçöes sentado e em decúbito horizontal ventral, nos resultados da PPQE.