RESUMO
PURPOSE: To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery. METHODS: Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: The primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures include IOP, glaucoma medical therapy, visual acuity, visual fields, and surgical complications. CONCLUSIONS: Practice patterns vary in the surgical management of glaucoma, and opinions differ among surgeons regarding the preferred primary operation for glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed glaucoma surgical procedures.
Assuntos
Alquilantes/administração & dosagem , Implantes para Drenagem de Glaucoma , Mitomicina/administração & dosagem , Implantação de Prótese/métodos , Trabeculectomia/métodos , Anti-Hipertensivos/administração & dosagem , Glaucoma de Ângulo Aberto/fisiopatologia , Glaucoma de Ângulo Aberto/cirurgia , Humanos , Pressão Intraocular/fisiologia , Oftalmoscopia , Complicações Pós-Operatórias , Reoperação , Tonometria Ocular , Resultado do Tratamento , Acuidade Visual/fisiologia , Testes de Campo Visual , Campos Visuais/fisiologiaAssuntos
Implantes para Drenagem de Glaucoma , Glaucoma de Ângulo Aberto/cirurgia , Trabeculectomia , Idoso , Alquilantes/administração & dosagem , Feminino , Glaucoma de Ângulo Aberto/fisiopatologia , Humanos , Pressão Intraocular/fisiologia , Masculino , Pessoa de Meia-Idade , Mitomicina/administração & dosagem , Tonometria Ocular , Falha de Tratamento , Resultado do TratamentoRESUMO
Importance: If preperimetric glaucoma reduces patient-reported vision-related quality of life (VRQoL), clinicians might consider earlier and more aggressive treatment of some patients with ocular hypertension and early glaucoma. Objective: To determine the impact of preperimetric glaucoma and early glaucomatous visual field (VF) loss on participants' VRQoL compared with participants who did not develop glaucoma in the Ocular Hypertension Treatment Study (OHTS). Design, Setting, and Participants: This cross-sectional study used data from participants enrolled in the OHTS from 1994 to 1996 who completed 20-year examination follow-up and VRQoL surveys from January 7, 2016, to November 19, 2019. Diagnosis of primary open-angle glaucoma (POAG) required reproducible changes in VFs or optic discs as determined by reading centers and attributed to glaucoma by a masked end point committee. Data analysis was performed from June 27, 2023 to March 7, 2024. Exposure: Ocular hypertension and glaucoma. Main Outcomes and Measures: Cross-sectional analysis of Rasch-calibrated total scores of the National Eye Institute Visual Function Questionnaire (VFQ) and the Glaucoma Quality of Life (GQL) survey was performed. Total scores were standardized from 0 (poor) to 100 (good). The main outcomes were differences in total VRQoL scores between participants who did not develop POAG (control) and 4 mutually exclusive POAG groups: unilateral or bilateral disc POAG with no glaucomatous VF loss in either eye and unilateral or bilateral VF POAG with or without disc changes. Differences in total VRQoL scores were analyzed using univariate and multivariate linear regression models. Results: Of 1636 participants originally enrolled in the OHTS, 679 (42%) completed the 20-year examination and VRQoL surveys. Of those participants completing 20-year follow-up, mean (SD) participant age at follow-up was 73.8 (7.7) years, and 412 of 679 participants (60.7%) self-reported as female. The mean (SD) Rasch-calibrated total VFQ scores were 72.5 (13.4) in the no POAG group (control) vs 72.7 (13.8) in the unilateral disc POAG group (difference, 0.17; 95% CI, -3.17 to 3.41; P = .92), 73.4 (14.0) in the bilateral disc POAG group (difference, 0.92; 95% CI, -2.93 to 4.77; P = .64), 69.2 (14.5) in the unilateral VF POAG group (difference, 3.33; 95% CI, -6.38 to -0.27; P = .03), and 58.5 (16.9) in the bilateral VF POAG group (difference, -13.96; 95% CI, -17.73 to -10.19; P<.001). Similar results were found for the GQL questionnaire. Conclusions and Relevance: In this cross-sectional study, among the surviving participants of OHTS who completed the 20-year follow-up examination, those participants who developed preperimetric POAG but no glaucomatous VF loss did not report lower VFQoL compared with participants who did not develop POAG. This finding should allow clinicians and patients the time to determine the frequency of examinations and whether the initiation of treatment is appropriate.
RESUMO
Medicare claims data and surveys of the American Glaucoma Society membership show that aqueous shunts are being increasingly utilized in the surgical management of glaucoma. New clinical trials data have identified differences in the efficacy and safety of shunts in common use. Recent studies have reported comparable results with trabeculectomy and aqueous shunts in similar patient groups. Intraoperative and postoperative complications may develop with aqueous shunt surgery related to the implantation of a foreign material. Several modifications in surgical technique have been directed toward improving surgical success, reducing complications, and optimizing efficiency and cost.
Assuntos
Implantes para Drenagem de Glaucoma , Glaucoma/cirurgia , Humanos , Implantação de Prótese , TrabeculectomiaRESUMO
Importance: Ocular hypertension is an important risk factor for the development of primary open-angle glaucoma (POAG). Data from long-term follow-up can be used to inform the management of patients with ocular hypertension. Objective: To determine the cumulative incidence and severity of POAG after 20 years of follow-up among participants in the Ocular Hypertension Treatment Study. Design, Setting, and Participants: Participants in the Ocular Hypertension Treatment Study were followed up from February 1994 to December 2008 in 22 clinics. Data were collected after 20 years of follow-up (from January 2016 to April 2019) or within 2 years of death. Analyses were performed from July 2019 to December 2020. Interventions: From February 28, 1994, to June 2, 2002 (phase 1), participants were randomized to receive either topical ocular hypotensive medication (medication group) or close observation (observation group). From June 3, 2002, to December 30, 2008 (phase 2), both randomization groups received medication. Beginning in 2009, treatment was no longer determined by study protocol. From January 7, 2016, to April 15, 2019 (phase 3), participants received ophthalmic examinations and visual function assessments. Main Outcomes and Measures: Twenty-year cumulative incidence and severity of POAG in 1 or both eyes after adjustment for exposure time. Results: A total of 1636 individuals (mean [SD] age, 55.4 [9.6] years; 931 women [56.9%]; 1138 White participants [69.6%]; 407 Black/African American participants [24.9%]) were randomized in phase 1 of the clinical trial. Of those, 483 participants (29.5%) developed POAG in 1 or both eyes (unadjusted incidence). After adjusting for exposure time, the 20-year cumulative incidence of POAG in 1 or both eyes was 45.6% (95% CI, 42.3%-48.8%) among all participants, 49.3% (95% CI, 44.5%-53.8%) among participants in the observation group, and 41.9% (95% CI, 37.2%-46.3%) among participants in the medication group. The 20-year cumulative incidence of POAG was 55.2% (95% CI, 47.9%-61.5%) among Black/African American participants and 42.7% (95% CI, 38.9%-46.3%) among participants of other races. The 20-year cumulative incidence for visual field loss was 25.2% (95% CI, 22.5%-27.8%). Using a 5-factor baseline model, the cumulative incidence of POAG among participants in the low-, medium-, and high-risk tertiles was 31.7% (95% CI, 26.4%-36.6%), 47.6% (95% CI, 41.6%-53.0%), and 59.8% (95% CI, 53.1%-65.5%), respectively. Conclusions and Relevance: In this study, only one-fourth of participants in the Ocular Hypertension Treatment Study developed visual field loss in either eye over long-term follow-up. This information, together with a prediction model, may help clinicians and patients make informed personalized decisions about the management of ocular hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT00000125.
RESUMO
PURPOSE OF REVIEW: The Tube Versus Trabeculectomy (TVT) Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube-shunt surgery to trabeculectomy with mitomycin (MMC) in eyes with previous cataract and/or unsuccessful glaucoma surgery. This article reviews published results from the TVT Study. RECENT FINDINGS: Tube-shunt surgery had a higher success rate than trabeculectomy with MMC during the first 3 years of follow-up. Trabeculectomy with MMC produced greater intraocular pressure (IOP) reduction in the early postoperative period compared with tube-shunt placement, but similar IOPs were observed after 3 months. Tube-shunt surgery was associated with greater use of adjunctive-medical therapy than trabeculectomy with MMC during the first 2 years of the study, but no difference in medication use was seen at 3 years. The incidence of postoperative complications was higher after trabeculectomy with MMC compared with tube-shunt surgery, but serious complications associated with vision loss and/or reoperation developed with similar frequency after both surgical procedures. No difference in the rate of vision loss was present following trabeculectomy with MMC and tube-shunt surgery after 3 years of follow-up. Cataract progression was common, but occurred with similar frequency with both procedures. SUMMARY: Intermediate-term results of the TVT Study support the expanded use of tube shunts beyond refractory glaucomas. Tube-shunt surgery is an appropriate surgical option in patients who have undergone prior cataract and/or unsuccessful filtering surgery.
Assuntos
Alquilantes/administração & dosagem , Implantes para Drenagem de Glaucoma , Glaucoma/cirurgia , Pressão Intraocular/fisiologia , Mitomicina/administração & dosagem , Trabeculectomia , Terapia Combinada , Glaucoma/fisiopatologia , Humanos , Implante de Lente Intraocular , Complicações Pós-Operatórias , Implantação de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
PURPOSE: To assess the impact of a masked Endpoint Committee on estimates of the incidence of primary open-angle glaucoma (POAG) treatment efficacy and statistical power of the Ocular Hypertension Treatment Study-Phase 1, 1994-2002 (OHTS-1). DESIGN: Retrospective interrater reliability analysis of endpoint attribution by the Endpoint Committee. METHODS: After study closeout, we recalculated estimates of endpoint incidence, treatment efficacy, and statistical power using all-cause endpoints and POAG endpoints. To avoid bias, only the first endpoint per participant is included in this report. RESULTS: The Endpoint Committee reviewed 267 first endpoints from 1636 participants. The Endpoint Committee attributed 58% (155 of 267) of the endpoints to POAG. The incidence of all-cause endpoints vs POAG endpoints was 19.5% and 13.2%, respectively, in the observation group and 13.1% and 5.8%, respectively, in the medication group. Treatment effect for all-cause endpoints was a 33% reduction in risk (relative risk = 0.67, 95% confidence interval [CI] of 0.54-0.84) and a 56% reduction in risk for POAG endpoints (relative risk = 0.44, 95% CI of 0.31-0.61). Post hoc statistical power for detecting treatment effect was 0.94 for all-cause endpoints and 0.99 for POAG endpoints. CONCLUSION: Endpoint Committee adjudication of endpoints improved POAG incidence estimates, increased statistical power, and increased calculated treatment effect by 23%. An Endpoint Committee should be considered in therapeutic trials when common ocular and systemic comorbidities, other than the target condition, could compromise study results.
Assuntos
Anti-Hipertensivos/uso terapêutico , Determinação de Ponto Final , Hipertensão Ocular/diagnóstico , Hipertensão Ocular/tratamento farmacológico , Adulto , Feminino , Glaucoma de Ângulo Aberto/diagnóstico , Glaucoma de Ângulo Aberto/prevenção & controle , Humanos , Pressão Intraocular/fisiologia , Masculino , Pessoa de Meia-Idade , Disco Óptico/patologia , Doenças do Nervo Óptico/diagnóstico , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Risco , Tonometria Ocular , Resultado do Tratamento , Transtornos da Visão/diagnóstico , Testes de Campo Visual , Campos Visuais/fisiologiaAssuntos
Glaucoma/cirurgia , Trabeculectomia , Ensaios Clínicos Controlados como Assunto , Glaucoma/diagnóstico , Glaucoma/fisiopatologia , Humanos , Pressão Intraocular , Disco Óptico/patologia , Avaliação de Resultados em Cuidados de Saúde , Tonometria Ocular , Acuidade Visual/fisiologia , Campos VisuaisRESUMO
PURPOSE: The Tube Versus Trabeculectomy (TVT) Study will compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous intraocular surgery. DESIGN: Multicenter randomized clinical trial. SETTING: 17 Clinical Centers. STUDY POPULATION: Patients 18 to 85 years of age who have undergone previous trabeculectomy, cataract extraction with intraocular lens implantation, or both and have inadequately controlled glaucoma with intraocular pressure (IOP) >or=18 mm Hg and Assuntos
Implantes para Drenagem de Glaucoma
, Glaucoma/cirurgia
, Trabeculectomia/métodos
, Adulto
, Idoso
, Idoso de 80 Anos ou mais
, Feminino
, Gonioscopia
, Humanos
, Pressão Intraocular
, Masculino
, Pessoa de Meia-Idade
, Mitomicina/administração & dosagem
, Oftalmoscopia
, Implantação de Prótese
, Qualidade de Vida
, Projetos de Pesquisa
, Segurança
, Tonometria Ocular
, Resultado do Tratamento
, Testes de Campo Visual
RESUMO
BACKGROUND: Primary open-angle glaucoma (POAG) is one of the leading causes of blindness in the United States and worldwide. Three to 6 million people in the United States are at increased risk for developing POAG because of elevated intraocular pressure (IOP), or ocular hypertension. There is no consensus on the efficacy of medical treatment in delaying or preventing the onset of POAG in individuals with elevated IOP. Therefore, we designed a randomized clinical trial, the Ocular Hypertension Treatment Study. OBJECTIVE: To determine the safety and efficacy of topical ocular hypotensive medication in delaying or preventing the onset of POAG. METHODS: A total of 1636 participants with no evidence of glaucomatous damage, aged 40 to 80 years, and with an IOP between 24 mm Hg and 32 mm Hg in one eye and between 21 mm Hg and 32 mm Hg in the other eye were randomized to either observation or treatment with commercially available topical ocular hypotensive medication. The goal in the medication group was to reduce the IOP by 20% or more and to reach an IOP of 24 mm Hg or less. MAIN OUTCOME MEASURES: The primary outcome was the development of reproducible visual field abnormality or reproducible optic disc deterioration attributed to POAG. Abnormalities were determined by masked certified readers at the reading centers, and attribution to POAG was decided by the masked Endpoint Committee. RESULTS: During the course of the study, the mean +/- SD reduction in IOP in the medication group was 22.5% +/- 9.9%. The IOP declined by 4.0% +/- 11.6% in the observation group. At 60 months, the cumulative probability of developing POAG was 4.4% in the medication group and 9.5% in the observation group (hazard ratio, 0.40; 95% confidence interval, 0.27-0.59; P<.0001). There was little evidence of increased systemic or ocular risk associated with ocular hypotensive medication. CONCLUSIONS: Topical ocular hypotensive medication was effective in delaying or preventing the onset of POAG in individuals with elevated IOP. Although this does not imply that all patients with borderline or elevated IOP should receive medication, clinicians should consider initiating treatment for individuals with ocular hypertension who are at moderate or high risk for developing POAG.
Assuntos
Anti-Hipertensivos/uso terapêutico , Glaucoma de Ângulo Aberto/prevenção & controle , Pressão Intraocular/efeitos dos fármacos , Administração Tópica , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Seguimentos , Glaucoma de Ângulo Aberto/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Hipertensão Ocular/diagnóstico , Hipertensão Ocular/prevenção & controle , Soluções Oftálmicas , Disco Óptico/patologia , Cooperação do Paciente , Segurança , Resultado do Tratamento , Acuidade Visual , Campos VisuaisRESUMO
BACKGROUND: The Ocular Hypertension Treatment Study (OHTS) has shown that topical ocular hypotensive medication is effective in delaying or preventing the onset of primary open-angle glaucoma (POAG) in individuals with elevated intraocular pressure (ocular hypertension) and no evidence of glaucomatous damage. OBJECTIVE: To describe baseline demographic and clinical factors that predict which participants in the OHTS developed POAG. METHODS: Baseline demographic and clinical data were collected prior to randomization except for corneal thickness measurements, which were performed during follow-up. Proportional hazards models were used to identify factors that predicted which participants in the OHTS developed POAG. RESULTS: In univariate analyses, baseline factors that predicted the development of POAG included older age, race (African American), sex (male), larger vertical cup-disc ratio, larger horizontal cup-disc ratio, higher intraocular pressure, greater Humphrey visual field pattern standard deviation, heart disease, and thinner central corneal measurement. In multivariate analyses, baseline factors that predicted the development of POAG included older age, larger vertical or horizontal cup-disc ratio, higher intraocular pressure, greater pattern standard deviation, and thinner central corneal measurement. CONCLUSIONS: Baseline age, vertical and horizontal cup-disc ratio, pattern standard deviation, and intraocular pressure were good predictors for the onset of POAG in the OHTS. Central corneal thickness was found to be a powerful predictor for the development of POAG.
Assuntos
Glaucoma de Ângulo Aberto/diagnóstico , Administração Tópica , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/uso terapêutico , Córnea/patologia , Método Duplo-Cego , Feminino , Glaucoma de Ângulo Aberto/etnologia , Glaucoma de Ângulo Aberto/prevenção & controle , Humanos , Pressão Intraocular/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Hipertensão Ocular/diagnóstico , Hipertensão Ocular/etnologia , Hipertensão Ocular/prevenção & controle , Disco Óptico/patologia , Modelos de Riscos Proporcionais , Fatores de RiscoRESUMO
PURPOSE: To describe a technique for laser suture lysis with non-valved aqueous drainage implants. METHODS: The surgical juxtaposition of the aqueous drainage tube and notched scleral graft allows the ligature to be placed in a predictable position aiding laser suture lysis. RESULTS: After drainage device encapsulation limits the possibility of hypotony, this technique allows easy postoperative lysis of drainage tube ligatures. CONCLUSION: This simple modification of surgical technique aids surgeons in finding and releasing aqueous drainage device ligature sutures.
Assuntos
Humor Aquoso , Drenagem , Lasers , Técnicas de Sutura , Drenagem/métodos , Ligadura/métodosRESUMO
OBJECTIVE: To compare the safety and efficacy of earlier vs later treatment in preventing primary open-angle glaucoma (POAG) in individuals with ocular hypertension. METHODS: One thousand six hundred thirty-six individuals with intraocular pressure (IOP) from 24 to 32 mm Hg in 1 eye and 21 to 32 mm Hg in the fellow eye were randomized to observation or to topical ocular hypotensive medication. Median time of treatment in the medication group was 13.0 years. After a median of 7.5 years without treatment, the observation group received medication for a median of 5.5 years. To determine if there is a penalty for delaying treatment, we compared the cumulative proportions of participants who developed POAG at a median follow-up of 13 years in the original observation group and in the original medication group. MAIN OUTCOME MEASURES: Cumulative proportion of participants who developed POAG. RESULTS: The cumulative proportion of participants in the original observation group who developed POAG at 13 years was 0.22 (95% confidence interval [CI], 0.19-0.25), vs 0.16 (95% CI, 0.13-0.19) in the original medication group (P = .009). Among participants at the highest third of baseline risk of developing POAG, the cumulative proportion who developed POAG was 0.40 (95% CI, 0.33-0.46) in the original observation group and 0.28 (95% CI, 0.22-0.34) in the original medication group. There was little evidence of increased adverse events associated with medication. APPLICATION TO CLINICAL PRACTICE: Absolute reduction was greatest among participants at the highest baseline risk of developing POAG. Individuals at high risk of developing POAG may benefit from more frequent examinations and early preventive treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000125.
Assuntos
Anti-Hipertensivos/uso terapêutico , Glaucoma de Ângulo Aberto/prevenção & controle , Pressão Intraocular/efeitos dos fármacos , Hipertensão Ocular/tratamento farmacológico , Feminino , Seguimentos , Glaucoma de Ângulo Aberto/diagnóstico , Glaucoma de Ângulo Aberto/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Hipertensão Ocular/fisiopatologia , Fatores de Risco , Escotoma/diagnóstico , Perfil de Impacto da Doença , Inquéritos e Questionários , Fatores de Tempo , Campos VisuaisRESUMO
The aqueous shunts that are currently available are based on the principles of the Molteno implant, i.e., a permanent sclerostomy, routing of aqueous to the equatorial subconjunctival space, and an end plate to prevent obstruction, and also to determine the surface area for absorption. While the Ahmed Glaucoma Valve appears to have improved the predictability of early intraocular pressure (IOP) control, the Baerveldt Glaucoma Implant has a tendency towards a lower rate of long-term excessive encapsulation. As a result of improvements in predictability, shunts are used more widely. Because of these positive factors, and ongoing concerns regarding the bleb-related problems associated with mitomycin C trabeculectomy, there is an increasing interest in the use of shunts as primary surgical management for primary glaucoma. At present, the main barrier to wider use of shunts in less-complicated glaucomas will probably be the unknown long-term effect on corneal endothelium, an issue that has not yet been properly addressed.
Assuntos
Implantes para Drenagem de Glaucoma/estatística & dados numéricos , Implantes para Drenagem de Glaucoma/tendências , Glaucoma/cirurgia , Catarata/etiologia , Catarata/patologia , Ensaios Clínicos como Assunto , Córnea/metabolismo , Córnea/patologia , Glaucoma/tratamento farmacológico , Glaucoma/patologia , Implantes para Drenagem de Glaucoma/efeitos adversos , Humanos , Pressão Intraocular , Soluções Oftálmicas/uso terapêutico , Esclerostomia , Trabeculectomia/efeitos adversosRESUMO
The disease glaucoma is now defined by characteristic optic disc and visual field change, without specific reference to the intraocular pressure (IOP). Success of treatment is no longer judged by the mere attainment of IOP less than 21 mmHg. Controversy remains, however, in deciding appropriate management where optic disc and/or visual field damage continues to progress despite a 'normal' IOP having been achieved with medical treatment. A panel of international glaucoma experts has provided management recommendations in four clinical scenarios--open-angle glaucoma, open-angle glaucoma in a myopic contact lens wearer, uveitic glaucoma and open-angle glaucoma in combination with visually significant cataract--where optic nerve and visual field progression has continued despite an IOP less than 21 mmHg on full medical treatment. Surgical intervention with mitomycin trabeculectomy is the most favoured further therapy.
Assuntos
Anti-Hipertensivos/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Pressão Intraocular/fisiologia , Adulto , Catarata/complicações , Lentes de Contato , Progressão da Doença , Quimioterapia Combinada , Feminino , Glaucoma de Ângulo Aberto/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Miopia/complicações , Guias de Prática Clínica como Assunto , Trabeculectomia/métodos , Falha de Tratamento , Uveíte/complicações , Transtornos da Visão/prevenção & controle , Campos VisuaisRESUMO
The baerveldt implant is a relatively new glaucoma drainage device. It offers the advantages of a large surface area implant (350 or 425 mm2), yet requires only a single quadrant conjunctival incision for insertion. Its features make it easier to install than other large implants. The authors herein describe currently a vailable Baerveldt implants, and the operative procedure for their installation.