Guía de práctica clínica para el manejo de glaucoma de ángulo abierto: guía en versión extensa / Clinical Practice Guideline for the Management of Open-Angle Glaucoma: Comprehensive Version Guide

El tratamiento oportuno de personas con glaucoma primario de ángulo abierto busca minimizar el número de complicaciones por esta enfermedad. Por ello, el Seguro Social de Salud del Perú (EsSalud) priorizó la realización de la presente guía de práctica clínica (GPC) con la finalidad de establecer recomendaciones basadas en evidencia para gestionar de la mejor manera los procesos y procedimientos asistenciales relacionados a esta condición clínica. Esta GPC fue realizada por la Dirección de Guías de Práctica Clínica, Farmacovigilancia y Tecnovigilancia del Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) de EsSalud.

Trabeculotomy versus combined trabeculotomy-trabeculectomy for primary congenital glaucoma: study protocol of a randomised controlled trial.

INTRODUCTION: Trabeculotomy and combined trabeculotomy-trabeculectomy (CTT) are major surgical options for primary congenital glaucoma (PCG). However, it is unclear which of these two surgical procedures should be recommended as the optimum first-line treatment for PCG. This trial aims to determine whether the outcomes of trabeculotomy are non-inferior to those of CTT in moderate PCG with a horizontal corneal diameter (HCD) of 12-14 mm. METHODS AND ANALYSIS: This is a 3-year, non-inferiority, prospective, randomised controlled trial. We plan to recruite 248 participants (aged ≤3 years) with PCG with an HCD of 12-14 mm from the Department of Glaucoma, Zhongshan Ophthalmic Center, Guangzhou, China. One eye per participant will be randomly (1:1) assigned to receive trabeculotomy or CTT. The primary outcome is the 3-year postoperative success rate in lowering intraocular pressure (IOP), and the secondary clinical outcomes will include IOP reduction, visual acuity, HCD, central corneal thickness, axial length, cup-disc ratio, refractive error and postoperative complications. Data will be analysed by the intention-to-treat principle. ETHICAL APPROVAL AND DISSEMINATION: The study protocol has been approved by the ethics committee of Zhongshan Ophthalmic Center (2014MEKY023) and the '5010 Plan' evaluation committee at Sun Yat-Sen University, Guangzhou, China. The results will be disseminated in international academic meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR-IOR-14005588; Date registered: 20 November 2014.

Surgical Outcomes and Quality Assessment of Trabeculectomy: Leveraging Electronic Health Records for Clinical Data Visualization.

PRéCIS:: This electronic medical record-based study demonstrates 1 approach to monitor clinical outcomes for individual physicians performing trabeculectomy. PURPOSE: The purpose of this study was to develop an interactive data visualization platform for evaluating trabeculectomy outcomes and monitoring clinical care quality. PATIENTS AND METHODS: This is a retrospective electronic health record study in a glaucoma division of an academic medical center. We included 633 patients who underwent trabeculectomy between July 2016 and December 2018. Data were collected for intraocular pressure (IOP), vision loss, number of follow-up visits, and return to the operating room within the initial 3 months. Regression analyses were used to assess factors associated with these study outcomes. Risk of IOP ≤5 mm Hg was assessed using survival analysis. An interactive data visualization platform was created. RESULTS: A total of 429 trabeculectomy and 204 combined surgeries were analyzed, with preoperative IOP of 21.9±9.4 and 19.4±6.9 mm Hg, respectively. Mean pressure declined by 53% and 41% (P=0.001) by 3 months. Risk of pressure ≤5 mm Hg was higher in white patients and those who underwent trabeculectomy alone. At 3 months, patients on average had 5 clinic visits; 5.5% required additional surgical procedures, and 18% experienced loss of at least 3 lines of best-recorded (not best-corrected) vision. Returning to the operating room was significantly associated with an increased number of clinic visits (coefficient=3.94) and higher odds of vision loss (odds ratio=11.12). CONCLUSIONS: Over the initial 3 months after trabeculectomy, additional surgeries are rare, while a significant proportion of patients lost vision, and this was strongly associated with a need to return to the operating room. Interactive electronic health record data visualization can be a useful tool for monitoring clinical outcomes.

Primary Trabeculectomy Outcomes by Glaucoma Fellows in a Tertiary Hospital in Brazil.

PURPOSE: To examine outcomes of trabeculectomy with mitomycin C for uncontrolled glaucoma when performed by glaucoma trainee surgeons. MATERIALS AND METHODS: Retrospective case series of patients who underwent trabeculectomy with mitomycin C. Primary outcome was to assess the rate of failure, which was defined as intraocular pressure in 2 consecutive visits >18 or <5 mm Hg or intraocular pressure reduction <30% from baseline, additional glaucoma surgery, or loss of light perception. The secondary outcome was to investigate risk factors for failure and surgical complications. RESULTS: One hundred forty-three eyes from 126 glaucoma patients underwent primary trabeculectomy between 2013 and 2014 at University of Campinas. Mean follow-up time was 1.47±0.96 years. Kaplan-Meier analysis showed cumulative survival rates of 70.1%, 62.5%, and 57.8%, after 1, 2, and 3 years, respectively. Multivariate analysis with generalized estimating equations revealed that neovascular glaucoma [odd ratios (OR): 5.05, P=0.043], suture lysis (OR: 8.89, P=0.011), and early bleb leak (OR: 4.63, P=0.011) were risk factors for failure. CONCLUSIONS: A success rate of approximately 60% was obtained 3 years after primary trabeculectomy performed by trainees. Patients with neovascular glaucoma, who underwent suture lysis and who presented an early bleb leak had an increased risk for failure during follow-up.

Repeatability of selective laser trabeculoplasty for open-angle glaucoma.

BACKGROUND: To analyze the results of repeat selective laser trabeculoplasty (SLT). INCLUSION CRITERIA: participants with primary or secondary open-angle glaucoma (excluding uveitic) who had undergone SLT 360° (SLT 1) with diminution of response over time followed by repeat SLT 360° (SLT 2). Six months of follow-up were required and at least 6 months in between SLT 1 and 2. The main outcome measures were IOP reduction at 6 and 12 months and a comparison of the response between SLT 1 and 2. RESULTS: One hundred thirty-seven patients met the inclusion criteria. If only one eye had repeat treatment, that eye was chosen; if both eyes qualified, one was chosen at random. The baseline intraocular pressure (IOP) for SLT 1 = 20.3+/- 5.2 mmHg and SLT 2 = 19.4 +/- 5.0 was reduced to 16.4 +/- 3.9 and 16.7 +/- 4.7 at 1 year, respectively (p < .001). Medication use was not significantly changed, and was 2.2 +/- 1.2 at baseline for SLT 1 and 2.1 +/- 1.3 for SLT 2, and at 1 year was 1.9 +/- 1.3 and 2.2 +/- 1.2, respectively. A subanalysis of 62 patients matched for equivalent baselines showed a baseline IOP = 18.7 +/- 3.8 for SLT 1 and 18.7 +/- 3.5 for SLT 2, reduced to 16.0 +/- 4.3 and 15.3 +/- 3.8 at 1 year (p < .001). CONCLUSION: Repeat SLT laser (360-degree treatment, followed by a loss of effect over time, then a second 360-degree treatment) in this population resulted in IOP lowering similar to that of the initial treatment.

Trabeculectomy Outcomes by Supervised Trainees in a Veterans Affairs Medical Center.

PURPOSE: To evaluate the outcomes of trabeculectomy performed in an ophthalmology training program. DESIGN: Retrospective study. PARTICIPANTS: A total of 160 patients undergoing trabeculectomy performed by a resident or fellow under attending supervision. MATERIALS AND METHODS: Trabeculectomy surgeries performed by a supervised resident or fellow surgeon between October 2000 and April 2010 were reviewed. Success was considered to be complete or partial if intraocular pressure (IOP)-lowering medications were not or were required to achieve IOP≤21 mm Hg, respectively. Failure was defined as IOP>21 mm Hg on 2 consecutive visits, loss of light perception vision, IOP≤5 on 2 consecutive visits with associated visual acuity loss of ≥2 lines, or need for surgical intervention. Trabeculectomy survival was determined using Kaplan-Meier analysis through 60 months of follow-up. MAIN OUTCOME MEASURES: Final IOP, success/failure rate. RESULTS: Complete success was achieved in 65 patients (41%). The average final IOP of this group was 9.1±3.7 mm Hg. Qualified success was achieved in 56 patients (35%). The average final IOP of this group was 11.5±6.4 mm Hg. At 60 months, the estimated cumulative probability of survival for complete and qualified successes was 28.9% and 63.7%, respectively. CONCLUSIONS: Among patients undergoing trabeculectomy by supervised residents or glaucoma fellows in a large Veterans Affairs Medical Center, IOP reduction was significant and similar to published studies. Trabeculectomy remains a successful intervention to lower IOP, with satisfactory success rates in the hands of trainee surgeons.

Factores pronósticos de fracaso de la trabeculectomía en una población de Cuba / Prognostic factors for trabeculectomy failure in a Cuban population

OBJETIVO: Identificar los factores pronósticos de fracaso a medio plazo en la trabeculectomía. MÉTODO: Cohorte prospectiva en 113 ojos (113 pacientes) con glaucomas primarios de ángulo abierto o cerrado, pigmentario o juvenil que fueron intervenidos de trabeculectomía. Se definió fracaso si la presión intraocular mayor o igual de 18 mmHg con medicación (2 o más colirios), entre 1-4 años postoperatorios. Se calculó riesgo relativo y análisis de regresión logística. RESULTADOS: La trabeculectomía previa, la presión intraocular preoperatoria ≥ 31 mmHg, la raza negra y el daño glaucomatoso avanzado incrementaron el riesgo de fracaso en 7,9 veces (p = 0,036), 5,3 veces (p = 0,011) y 4,7 veces (p = 0,028 y p = 0,027), respectivamente. La presencia conjunta de 2 o más factores lo incrementó en 6,4 veces (p < 0,001). No se afectó por edad, sexo, colirios preoperatorios ni complicaciones quirúrgicas. CONCLUSIONES: La trabeculectomía previa, la presión intraocular preoperatoria ≥ 31 mmHg, la raza negra y el daño glaucomatoso avanzado son factores pronósticos de fracaso de la trabeculectomía, en orden decreciente de su asociación con el fracaso. La presencia conjunta de 2 o más factores incrementa el riesgo de fracaso. En estas situaciones se indica el uso de antimetabolitos transoperatorios

OBJECTIVE: To identify the prognostic factors for mid-term trabeculectomy failure. METHOD: A prospective cohort study was conducted on 113 eyes (113 patients) that had undergone a trabeculectomy for primary open or closed angle, pigmentary, or juvenile glaucoma. Surgical failure was defined if intraocular pressure was equal or more than 18 mmHg with medication (two or more drops), after 1-4 postoperative years. The relative risk was calculated and a logistic regression analysis was performed. RESULTS: Previous trabeculectomy, preoperative intraocular pressure ≥ 31 mmHg, black race, and advanced glaucoma increased the failure risk by 7.9 times (P=.036), 5.3 times (P=.011) and 4.7 times (P=.028, andP=.027), respectively. The addition of two or more factors increased the risk by 6.4 times (P<.001). It was not affected by age, sex, pre-operative drops, or surgical complication. CONCLUSIONS: Previous trabeculectomy, pre-operative intraocular pressure ≥ 31 mmHg, black race, and advanced glaucoma are prognostic factors for trabeculectomy failure, in decreasing order of their association with surgical failure. The addition of two or more factors increased the risk of failure. In those situations, the use of trans- operative anti-metabolites is suggested

Meta-analysis of randomized controlled trials comparing EX-PRESS implantation with trabeculectomy for open-angle glaucoma.

PURPOSE: To evaluate the efficacy and safety of EX-PRESS implantation compared with trabeculectomy for uncontrolled open-angle glaucoma. METHODS: Pertinent randomized controlled trials were identified through systematic searches of the PubMed, EMBASE, and Cochrane Library. The efficacy measures utilized were the weighted mean differences (WMDs) for the intraocular pressure reduction (IOPR), the reduction in glaucoma medications, the change of visual acuity, and the relative risks (RRs) for operative success rates. The safety measures utilized were RRs for postoperative complications. The pooled effects were calculated using the random-effects model. RESULTS: Four randomized controlled trials of 292 eyes were included in this meta-analysis. The WMDs of the IOPR comparing the EX-PRESS with trabeculectomy were -0.25 (95% Cl: -3.61 to 3.11) at 6 month, 0.053 (-4.31 to 4.42) at 12 months, 0.81 (-4.06 to 5.67) at 24 months, and 0.20 (-2.11 to 2.51) at final follow-up. There was no statistically significance for IOPR at any point after surgery. There were also no significant differences in the reduction in glaucoma medications or visual acuity between the groups. The pooled relative risks comparing EX-PRESS with Trabeculectomy were 1.36 (1.11 to 1.66) for the complete operative success rate and 1.05 (0.94 to 1.17) for the qualified operative success rate. EX-PRESS and Trabeculectomy were associated with similar incidences in most complications with the exception of hyphema, with pooled RR being 0.18 (0.046 to 0.66). CONCLUSIONS: EX-PRESS implantation and trabeculectomy have similar efficacy in IOP-lowering, medication reduction, vision recovery, and qualified operative success rates. EX-PRESS associated with higher rates of complete operative success and fewer hyphema than with Trabeculectomy. However, these should be interpreted with caution because of the inherent limitations of the included studies.

Audit of ophthalmic surgical interventions in a resource-deficient tertiary eye care facility in Sub-Saharan Africa.

BACKGROUND: Ophthalmic surgical intervention is a critical component of therapeutic eye care services. Periodic audit of its output and outcome is needed to monitor service effectiveness and inform evidence-based eye health care reforms, in the spirit of VISION 2020-The Right to Sight. Objectives. To investigate the pattern and results of ophthalmic surgical interventions at the University of Nigeria Teaching Hospital (UNTH), Enugu, Nigeria. METHODS: The UNTH's eye theatre surgical logbook and patients' clinical charts were retrospectively reviewed, from August 2003-July 2008, to obtain patients' relevant demographic and clinical data. Personnel data were obtained from UNTH's human resources department. Descriptive and analytical statistics were performed. A p<.01 was considered statistically significant. RESULTS: Of the 881 eye operations on 676 patients, cataract extraction (45.1%), pterygium excision (18.4%) and trabeculectomy (7.5%) were the main surgeries performed. The yearly surgical output per surgeon was 23.2. The early outcome was satisfactory for trabeculectomy but sub-optimal for cataract surgery. Surgeries were performed mainly to restore or preserve vision (p<.01). CONCLUSIONS: The output and outcome of eye operations at UNTH, Enugu, are sub-optimal. Overcoming surgical uptake barriers, improved pre-operative evaluation, and provisions of micro-surgical consumables are instructive.

Trabeculectomy: the limitations for registrar training.

BACKGROUND: Trainee exposure to glaucoma surgery was analysed and outcomes compared with those of consultant cases. DESIGN: Retrospective review was carried out at Princess Alexandra Hospital and Royal Brisbane and Women's Hospital, two major tertiary teaching hospitals in Brisbane, Queensland, Australia. PARTICIPANTS: Two hundred and forty-eight consecutive public patients undergoing primary trabeculectomy surgery between 2003 and 2010. METHODS: The rate of trabeculectomy performed by trainees, the success and complication rates were examined and compared with those of consultant ophthalmologists. MAIN OUTCOME MEASURES: Intraocular pressure was divided into two groups of ≤21 mmHg and ≤15 mmHg and visual field progression. RESULTS: Two hundred and forty-eight primary trabeculectomy cases were performed between 2003 and 2010. Trainees carried out 145 cases (59%), making the rate of trabeculectomy operations 1.1 per trainee per year (16-17 trainees) as compared with 1.6 per trainee per year from 1996 to 2002 at the same institutions. Complications rates in the first postoperative week were similar between consultants and trainees, the most common being wound leak and hyphaema. An intraocular pressure of ≤15 mmHg without the use of topical medications was achieved in 25 out of 50 (50%) glaucoma-interest consultant, 24 out of 53 (45.3%) general consultant and 68 out of 145 (46.9%) trainee cases (P = 0.951). The rate of visual field progression was also statistically similar between trainees and consultants (19.5% and 21.3%), respectively. CONCLUSION: With increasing trainee numbers, the rate of trabeculectomy surgery is declining compared with previous years, with less trainee exposure to trabeculectomy surgery and inability to achieve surgical competency levels.

Glaucoma surgery: trainee outcomes and implications for future training: southeast Scotland.

AIM: Postoperative outcome of trainee glaucoma surgery compared with glaucoma specialist consultant surgery. Survey of Scottish consultant ophthalmologists' views on trainee surgery. METHOD: Retrospective analysis of 128 trainee and 176 consultant trabeculectomies, with minimum postoperative follow-up of 2 years. Prospective postal survey of 80 Scottish consultant ophthalmologists. RESULTS: Trainees operated mainly on cases of chronic open angle glaucoma, while consultants operated on significantly more complicated glaucomas (P=0.0004). Trainee cases had more bleb leaks (P=0.01), hypotony (P=0.05), early (P=0.01) and late (P=0.03) return to theatre, and bleb interventions (P=0.01). Trainee mitomycin trabeculectomies were associated with higher rates of return to theatre (P=0.002), and cataract extraction within the first postoperative year (P=0.002). Trainee cases of pseudoexfoliation had more early complications (P=0.024), and trainee cases of low tension required more bleb interventions (P=0.05). There was no significant difference (P>0.05) between average intra-ocular pressure control (IOP) at postoperative visit year 1 between consultant (14.3 mm Hg) and trainee (13.9 mm Hg) cases. More than 50% of the 80 Scottish ophthalmology consultants surveyed, indicated that glaucoma surgery training requirements should be retained. CONCLUSIONS: Trainee trabeculectomy cases showed significantly higher rates of early complications, return to theatres, and bleb interventions compared with consultant cases. Satisfactory IOP control was achieved in both groups at postoperative year 1. Trainee cases require careful preoperative selection, avoiding complicated glaucomas including pseudoexfoliation and low tension, and those that require mitomycin. The majority of Scottish consultants wish to retain glaucoma surgery within the remit of generic training.

South-East Scotland trabeculectomy survey.

AIM: Assessment of trabeculectomy in South-East Scotland (SESTS) with comparison to National Survey of Trabeculectomy (NST) and outcomes of consultant and trainee surgery. METHOD: A retrospective study of 304 consecutive, primary trabeculectomies, in two Scottish centres (Edinburgh and Dunfermline) with two glaucoma specialists and higher surgical trainees, was performed. The study group had primary open angle glaucoma (65.5%), pseudoexfoliation (6.9%), normal tension glaucoma (7.6%), pigment dispersion syndrome (1.6%), and other complicated glaucoma (18.4%). All patients underwent trabeculectomy by the glaucoma specialist (57.6%) and higher surgical trainee (42.4%) with close scrubbed supervision. RESULTS: Compared to the NST, the waiting time for surgery (<3 months) was significantly less in the SESTS (P<0.001). There was also significantly more use of intraoperative antimetabolites (P<0.01), bleb intervention (P<0.001), and a higher rate of early complications (P<0.025). There was no significant difference in outcome at intraocular pressure (IOP)<2/3 listing IOP (qualified and unqualified) between the SESTS and the NST. Significantly, more patients achieved an unqualified success of IOP<21 mmHg (P<0.01) and an unqualified success of IOP<16 mmHg in the SESTS than the NST (P<0.05). At 1 year post surgery, visual loss of greater than one Snellen line was more common in the NST (P<0.01) as was the use of anti-glaucoma medication (P<0.001). Trainee cases returned to theatre more frequently (P<0.025) and merited more bleb intervention (P<0.01) than consultant cases, but the long-term outcome was similar. CONCLUSION: Our study highlights significant changes in the practice and outcome of trabeculectomy compared to the national survey conducted a decade ago.

Recent advances in trabeculectomy technique.

PURPOSE OF REVIEW: Trabeculectomy is an effective operation for lowering intraocular pressure. However, success is limited by complications such as infection, hypotony, and scarring. RECENT FINDINGS: These complications, which are increased by antifibrotic use, can be reduced with attention to surgical technique. We highlight the benefit of sub-Tenon anaesthesia, careful choice of the surgical site, fashioning of the scleral flap to produce diffuse aqueous flow, and better intraocular pressure control, maintenance of intraocular pressure, a formed anterior chamber, with outflow control during surgery using an infusion, optimal method of antimetabolites application, new adjustable sutures, and corneal-conjunctival closure techniques. SUMMARY: These techniques reduce hypotony, producing a diffuse noncystic bleb with long-term pressure control.

A comparison between 90 degrees and 180 degrees selective laser trabeculoplasty.

PURPOSE: To compare two regimens of SLT, ie, SLT with 25 laser spots on 90 degrees of trabecular meshwork and SLT with 50 laser spots on 180 degrees of trabecular meshwork in patients with open-angle glaucoma. PATIENTS AND METHODS: In a prospective clinical study, the authors compared pressure-lowering effect of SLT in 2 groups of patients; 1 group (32 patients) received SLT with 25 laser spots on 90 degrees of trabecular meshwork, the other group (32 patients) SLT with 50 laser spots on 180 degrees of trabecular meshwork. RESULT: There was no difference in the pressure reduction between these two treatment regimens. Moreover, the pressure reduction was not influenced by previous ALT treatments. The pigmentation in the trabecular meshwork is related to a delayed effect on the pressure lowering after SLT. CONCLUSION: SLT with 25 laser spots on 90 degrees of trabecular meshwork has a similar pressure-lowering effect to SLT with 50 laser spots on 180 degrees of trabecular meshwork. The new treatment regimen with less laser spots could increase the repeatability of SLT and reduce potential tissue damage in the trabecular meshwork.

Evaluation of 56 trabeculectomy operations at Ago-Iwoye, Ogun State, Nigeria.

Records of 56 eyes of 34 patients who had trabeculectomy between February 1998 and October 1999 at the St. Mary's Catholic Eye Hospital Ago-Iwoye, Ogun State were reviewed retrospectively. There were 22 (64.7%) males and 12 (35.3%) females. Age range was from 18 years to 80 years, mean age 54 years. 22 patients had bilateral trabeculectomy and 12 patients had uniocular surgery. Intra ocular pressure control less than 21 mmHg post operatively was 74.1%; 96.2% was achieved with additional use of antiglaucoma medication; 3.7% could not be controlled on medication post operatively. Here was a statistically significant decrease in visual acuity post operatively. The Intra-operative and post-operative complications were minimal.

[Non perforating trabecular surgery with reticulated hyaluronic acid implant]. / La chirurgie non perforante du trabéculum avec implant d'acide hyaluronique réticulé.

Non perforating trabecular surgery (NPTS) with reticulated hyaluronic acid implant (Skgel) allows aqueous humor to leave anterior chamber through a thin trabeculo-Descemet's membrane into a sclerocorneal space filled with Skgel implant and then via the outflow physiological channels. Good IOP results are obtained with less or without external filtration decreasing the incidence of per- and postoperative complications described after trabeculectomy. This surgery is actually only indicated for primary open angle glaucoma, the trabeculectomy still remaining the gold standard procedure for the other glaucoma cases.