Monitoring ocular hypertension, how much and how often? : A cost-effectiveness perspective

Funding This work was part of the Surveillance for Ocular Hypertension study funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (07/46/02).Peer reviewedPostprin

LiGHT trial: 6-year results of primary selective laser trabeculoplasty versus eye drops for the treatment of glaucoma and ocular hypertension

PURPOSE: The LiGHT trial has shown selective laser trabeculoplasty (SLT) to be clinically and cost-effective as a primary treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT) at 3 years. This paper reports health-related quality of life (HRQL) and clinical effectiveness of initial treatment with SLT compared to intra-ocular pressure (IOP) lowering eye drops, after 6 years of treatment. DESIGN: Prospective multicentre randomized controlled trial. PARTICIPANTS: Treatment-naïve eyes with OAG or OHT, initially treated with SLT or IOP-lowering drops. METHODS: Patients were randomly allocated to initial SLT or eye drops. Eye specific target IOP and monitoring intervals were based on international guidelines. After the initial 3 years of the trial, patients in the SLT arm were permitted a 3rd SLT if necessary; patients in the drops arm were allowed SLT as a treatment switch or escalation. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223). MAIN OUTCOME MEASURES: The primary outcome was HRQL at 6 years; secondary outcomes were clinical effectiveness and safety. RESULTS: Of the 692 patients completing 3 years in the LiGHT trial, 633 (91.5%) entered the extension and 524 patients completed 6 years in the trial (82.8% of those entering the extension phase, 73% of those initially randomised). At 6 years, there were no significant differences in HRQL for EQ-5D, GUI and GQL-15 (all p>0.05). The SLT arm had better GSS scores than the drops arm (83.6 (SD 18.1) vs 81.3 (SD 17.3), respectively). 69.8% of eyes in the SLT arm remained at or below target IOP without the need for medical or surgical treatment. More eyes in the drops arm exhibited disease progression (26.8% vs 19.6%, respectively, p=0.006). Trabeculectomy was required in 32 eyes in the drops arm compared to 13 eyes in the SLT arm (p<0.001); there were more cataract surgeries in the drops arm (95 compared to 57 eyes, p=0.03). There were no serious laser-related adverse events. CONCLUSIONS: SLT is a safe treatment for OAG and OHT, providing better long-term disease control than initial drop therapy, with reduced need for incisional glaucoma and cataract surgery over 6 years

Visual field loss and vision-related quality of life in the Italian Primary Open Angle Glaucoma Study.

The aim of this study was to examine the relationship between visual field (VF) loss, vision-related quality of life (QoL) and glaucoma-related symptoms in a large cohort of primary open angle glaucoma (POAG) patients. POAG patients with or without VF defects or "glaucoma suspect" patients were considered eligible. QoL was assessed using the validated versions of the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and glaucoma-related symptoms were assessed using the Glaucoma Symptom Scale (GSS). Patients were classified as having VF damage in one eye (VFD-1), both eyes (VFD-2), or neither eye (VFD-0). 3227 patients were enrolled and 2940 were eligible for the analysis. 13.4% of patients were classified in the VFD-0, 23.7% in the VFD-1, and 62.9% in the VFD-2 group. GSS visual symptoms domain (Func-4) and GSS non-visual symptoms domain (Symp-6) scores were similar for the VFD-0 and VFD-1 groups (p = 0.133 and p = 0.834 for Func-4 and Symp-6, respectively). VFD-0 group had higher scores than VFD-2 both in Func-4 (p &lt; 0.001) and Symp-6 domains (p = 0.035). Regarding the NEI-VFQ-25, our data demonstrated that bilateral VF defects are associated with vision-related QoL deterioration, irrespective of visual acuity

Central corneal thickness among glaucoma patients attending Menelik II Hospital, Addis Ababa, Ethiopia

AbstractBackground: Glaucoma is one of the leading causes of blindness. Intra-ocular pressure is the main and only manageable of all risk factors for glaucoma. The central corneal thickness has been shown to affect the intra-ocular pressure measurement and is different among different ethnic population and subtypes of glaucoma. The central corneal thickness of different subtypes of glaucoma at Menelik II Hospital has not been determined.Objective: The objective of this study was to measure the mean central corneal thickness of different sub types of glaucoma and ocular hypertension of patients attending Menelik Hospital.Participants and Methods: A cross sectional comparative hospital-based study was carried out at the glaucoma clinic of Menelik ΙΙ Hospital to assess the pattern of central corneal thickness of patients with different subtypes of glaucoma from 01 May 2014 to 30 August 2014. Central corneal thickness was determined by taking average of six measurements using ultrasonic Pachymetry. All consecutive open angle glaucoma patients and age matched non-glaucoma patients were included in the study. Eyes with incisional surgery, corneal diseases or trauma were excluded. Data was collected entered, cleaned and analyzed using SPSS windows version 16. Level of significance was taken at 5% for association of corneal thickness measurement and glaucoma subtypes.Results: One hundred fourteen patients were examined. Twenty-three had primary open angle glaucoma, 16 had pseudoexfoliative glaucoma, 15 had Ocular hypertension, 32 had Normal tension glaucoma, and 28 were non-glaucoma patients. The mean Central corneal thickness for the group with Ocular hypertension, Primary open angle glaucoma, Pseudoexfoliative glaucoma, Normal tension glaucoma and non- glaucoma was 562.5±24.5μm, 517.5±27.5μm, 512.5±32.1μm, 488.0±32.4 μm, and 516.2±23.4μm respectively. Mean central corneal thickness in the ocular hypertension group was significantly higher (P&lt;0.001) than primary open angle glaucoma, pseudoexfoliative glaucoma, normal tension glaucoma subtypes and non-glaucoma patients. Patients with normal tension glaucoma had significantly lower mean central corneal thickness (P&lt;0.001) than primary open angle glaucoma, pseudoexfoliative glaucoma, subtypes, ocular hypertension and non-glaucoma group.Conclusions: Patients with ocular hypertension had a higher mean central corneal thickness. By contrast, the mean central corneal thickness of patients with normal tension glaucoma was relatively low. [Ethiop. J. Health Dev. 2018;32(1):54-59

Risk Assessment of Ocular Hypertension and the Use of Medication

Ocular hypertension (OHT) is the only known modifiable risk factor of glaucoma development. Intraocular pressure (IOP)-lowering therapy reduces the risk of glaucoma development. The 5-year risk of glaucoma conversion is <10% for untreated OHT patients. Cost-effectiveness analyses suggested that it is not cost-effective to treat all patients with OHT. Treatment should be targeted towards the higher-risk group—namely, patients with older age, a higher level of IOP, a thinner central corneal thickness (CCT), a larger vertical cup-to-disc ratio (VCDR) and a smaller pattern standard deviation (PSD) value on visual field (VF) test. These risk factors were established by the Ocular Hypertension Treatment Study (OHTS) and the European Glaucoma Prevention Study (EGPS). However, there is significant variability in the measurement of the currently known risk factors, especially if the assessment is taken from a longitudinal perspective. This can lead to overtreatment or under-treatment: the former exposing the patient to unnecessary side effects of IOP-lowering eye drops and the latter putting the patient at risk of developing glaucoma. The advancement of new VF algorithm and ocular imaging can lead to the identification of new approaches to risk stratification and, thus, more specific treatment for OHT patients

A comparative study on safety and efficacy of travoprost and brimonidine/timolol fixed combination in patients of primary open angle glaucoma

Background: The purpose of this study was to compare and evaluate the clinical efficacy of topically applied travoprost 0.004% eye drops versus brimonidine/timolol fixed combination eye drops in the management of primary open-angle glaucoma.Methods: In this prospective, randomized study, 65 patients received either travoprost eye drops once daily in the morning (n=33) or brimonidine/timolol fixed combination eye drops twice daily (n=32). Intra ocular pressure (IOP) was assessed at 2, 4, 8, and 12 weeks. The primary outcome measure was mean reduction in IOP.Results: Thebaseline mean IOP values were similar between two groups. Mean reduction of IOP in the right eye for brimonidine/timolol fixed combination group was 9±2.9 mmHg, whereas in the left eye it was 10.9±2.8 mmHg. In the travoprost group, the reduction in IOP of the right eye was 7.8±2.9 mmHg (p=0.0002) and 7.5±3.4 mmHg (p=0.0001) in the left eye. The mean reduction of IOP for the brimonidine/timolol group was 9.95 mmHg and for the travoprost group it was 7.6 mmHg (p<0.0001) in both the eyes.Conclusions: The fixed combination brimonidine/timolol twice daily demonstrated superior mean IOP lowering efficacy compared to travoprost 0.004% in patients with open-angle glaucoma

Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial

BACKGROUND: Primary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe alternative but is rarely used as first-line treatment. We compared the two. METHODS: In this observer-masked, randomised controlled trial treatment-naive patients with open angle glaucoma or ocular hypertension and no ocular comorbidities were recruited between 2012 and 2014 at six UK hospitals. They were randomly allocated (web-based randomisation) to initial selective laser trabeculoplasty or to eye drops. An objective target intraocular pressure was set according to glaucoma severity. The primary outcome was health-related quality of life (HRQoL) at 3 years (assessed by EQ-5D). Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness, and safety. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223). FINDINGS: Of 718 patients enrolled, 356 were randomised to the selective laser trabeculoplasty and 362 to the eye drops group. 652 (91%) returned the primary outcome questionnaire at 36 months. Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference (difference 0·01, 95% CI -0·01 to 0·03; p=0·23). At 36 months, 74·2% (95% CI 69·3-78·6) of patients in the selective laser trabeculoplasty group required no drops to maintain intraocular pressure at target. Eyes of patients in the selective laser trabeculoplasty group were within target intracoluar pressure at more visits (93·0%) than in the eye drops group (91·3%), with glaucoma surgery to lower intraocular pressure required in none versus 11 patients. Over 36 months, from an ophthalmology cost perspective, there was a 97% probability of selective laser trabeculoplasty as first treatment being more cost-effective than eye drops first at a willingness to pay of £20 000 per quality-adjusted life-year gained. INTERPRETATION: Selective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice. FUNDING: National Institute for Health Research, Health and Technology Assessment Programme

Study on erythropoietin subconjunctival administration in a glaucoma animal model

Tese de Doutoramento em Ciências Veterinárias na Especialidade de ClinicaGlaucoma is the number one cause of irreversible vision loss worldwide. Death of retinal ganglion cells (RGC), which results in the progressive loss of visual function, occurs in glaucoma and other ocular diseases caused by hypoxia and ischemia. Although glaucoma is a multifactorial neurodegenerative disease, the only currently method of treatment involves reduction of intraocular pressure and, at the present, there is no effective treatment to prevent RGC apoptosis. Notably, it has been reported that erythropoietin (EPO), a cytokine hormone produced in response to hypoxia, has significant neuroprotective and neuroregenerative properties in several types of ocular disorders. Pre-clinical studies in glaucoma animal models involving EPO have yielded very promising results. All studies involving EPO ocular administrations have used systemic, intravitreal or retrobulbar administration to reach retinal desired EPO concentrations. However, EPO chronic systemic administration can lead to adverse side effects related with haematopoiesis stimulation, while intravitreal or retrobulbar administrations are invasive procedures that can induce several complications such as endophthalmitis, retinal detachment, vitreitis, retinitis, choroiditis or cataracts. This thesis aims to clarify if EPO’s neuroprotection could be achieved by a non-invasive and safe periocular administration route without adverse effects. Being so, this work evaluates the subconjunctival route as an alternative for EPO administration in glaucoma disease. After the first in vitro study, where the permeation of EPO across the periocular tissues was quantified, all work was developed in in vivo models. EPO’s ocular permeation after subconjunctival administration was tested, both in physiological and glaucomatous conditions. Furthermore, both retinal morphological and physiological effects of EPO administered by this route were assessed in glaucomatous animals. Results showed that EPO, when administered subconjunctivally, can permeate the main ocular barriers and reach RGC layers, in both physiological and glaucomatous conditions, without significant local or systemic side effects. More than showing that EPO can reach the retina by this route, results also concluded that subconjunctival EPO administration seems to have structural and functional beneficial effects on the retina after glaucoma induction in rats.RESUMO - Estudo da administração subconjuntival de eritropoietina num modelo animal de glaucoma. - O glaucoma é a principal causa de cegueira irreversível no mundo. A morte das células ganglionares da retina (RGC) causada por hipóxia e isquémia resulta numa progressiva perda de visão. Apesar do glaucoma ser uma doença neurodegenerativa multifatorial, as únicas opções terapêuticas visam o controle da pressão intraocular, não havendo atualmente um tratamento eficaz para prevenir a apoptose das RGC. Estudos recentes demonstraram que a eritropoietina (EPO), uma glicoproteína sintetizada maioritariamente em resposta a estados de hipóxia, tem ação neuroprotetora e neuroregenerativa em várias doenças oculares, tendo revelado resultados promissores em vários modelos animais de glaucoma. Nos estudos experimentais em que a EPO foi utilizada como substância neuroprotetora, foi administrada pelas vias sistémica, intravítrea ou retrobulbar para se obterem concentrações terapêuticas na retina. No entanto, a administração sistémica prolongada de EPO pode produzir efeitos secundários adversos relacionados com o aumento da hematopoiese, enquanto que as administrações intravítrea ou retrobulbar são procedimentos invasivos suscetíveis de causar várias complicações tais como endoftalmite, descolamento de retina, vitreite, retinite, coroidite ou catarata. Esta tese teve por objetivo estudar uma via de administração periocular de EPO não invasiva, segura, eficaz e sem efeitos adversos. Assim, este trabalho avaliou a via subconjuntival como uma alternativa para a administração ocular de EPO em condições de glaucoma. No primeiro estudo in vitro, quantificou-se a permeação da EPO nos tecidos perioculares. O restante trabalho, desenvolvido em modelos in vivo, testou a permeação ocular da EPO após administração subconjuntival, tanto em condições fisiológicas como de glaucoma. O estudo contemplou ainda os efeitos morfológicos e fisiológicos da EPO ao nível da retina em animais glaucomatosos. Os resultados obtidos demostraram que a EPO, quando administrada pela via subconjuntival, pode permear as principais barreiras oculares e atingir as RGC, em ambas as condições testadas, fisiológicas e de glaucoma, sem efeitos adversos locais ou sistémicos apreciáveis. Além disso, revelaram que a administração subconjuntival de EPO parece ter efeitos benéficos estruturais e funcionais na retina após a indução de glaucoma experimental em ratos.N/

Estimating the Risk of Developing Glaucoma

The issue of risk assessment in glaucoma has received increasing attention in the past few years since the publication of results from the Ocular Hypertension Treatment Study. Predictive models have been developed in order to estimate the risk that patients with ocular hypertension will develop glaucoma if left untreated. The purpose of this article is to review issues on the development and validation of predictive models to estimate risk of glaucoma development. Current models are reviewed and details about their development and validation are provided