The effect of citicoline oral solution on quality of life in patients with glaucoma: the results of an international, multicenter, randomized, placebo-controlled cross-over trial.

PURPOSE: This study aims to evaluate whether the use of citicoline oral solution could improve quality of life in patients with chronic open-angle glaucoma (OAG). DESIGN: Randomized, double-masked, placebo-controlled, cross-over study was used. Patients were randomized to one of the two sequences: either citicoline 500 mg/day oral solution-placebo or placebo-citicoline 500 mg/day oral solution. Switch of treatments was done after 3 months; patients were then followed for other 6 months. Follow-up included 3-month, 6-month, and 9-month visits. OUTCOMES: The primary outcome was the mean change of "intra-patient" composite score of the Visual Function Questionnaire-25 (VFQ-25). after citicoline oral solution vs placebo at 6-month visit as compared with baseline. METHODS: The trial was multicenter, conducted at 5 European Eye Clinics. OAG patients with bilateral visual field damage, a mean deviation (MD) ranging from - 5 to - 13 dB in the better eye, and controlled IOP were included. VFQ-25 and SF-36 questionnaires were administered at baseline and at 3-, 6-, and 9-month visits. A mixed effect model, with a random effect on the intercept, accounted for correlations among serial measurements on each subject. RESULTS: The primary pre-specified outcome of the analysis reached statistical significance (p = 0.0413), showing greater improvement after citicoline oral solution. There was an increase in the composite score in both arms compared to baseline, but it was significant only for the placebo-citicoline arm (p = 0.0096, p = 0.0007, and p = 0.0006 for the three time-points compared to baseline). The effect of citicoline was stronger in patients with vision-related quality of life more affected by glaucoma at baseline. CONCLUSIONS: This is the first placebo-controlled clinical study evaluating the effect of a medical treatment aiming at improving vision-related quality of life in glaucomatous patients.

Intravitreal Corticosteroid Implantation in Diabetic Macular Edema: Updated European Consensus Guidance on Monitoring and Managing Intraocular Pressure.

Intravitreal therapy for diabetic macular edema can, in susceptible patients, increase intraocular pressure (IOP). As uncontrolled IOP can potentially be sight threatening, monitoring is an essential component of patient management. It can be challenging for retina specialists to ensure that monitoring is rigorous enough to detect and resolve any potential problems at the earliest opportunity without it also being overburdensome for patients who have the lowest risk of developing an IOP rise. We have developed dynamic algorithms that: (1) tailor the frequency and extent of monitoring according to individual susceptibility and current IOP and (2) assist retina specialists in deciding when they should consider a referral to a glaucoma specialist. One algorithm is for patients with a relatively low susceptibility to developing an IOP rise (those whose baseline IOP is < 22 mmHg and who do not have a history of IOP events). Depending on their first post-implantation IOP check, the algorithm classifies them as: low risk if IOP remains < 22 mmHg; medium risk if IOP is 22-25 mmHg and any rise from baseline is < 10 mmHg; or high risk if IOP is > 25 mmHg or any rise from baseline is ≥ 10 mmHg. Thereafter, the algorithm guides on the frequency and extent of monitoring required in each of these groups and, if IOP rises or falls during treatment, patients may move up or down the risk groups accordingly. A different algorithm is provided for patients who are more susceptible to developing an IOP rise (those with a baseline IOP of ≥ 22 mmHg or a prior history of an IOP event). These patients need monitoring more closely so this algorithm has only medium- or high-risk classifications. These algorithms update the previous monitoring guidance by Goñi et al. (Goñi et al. in Ophthalmol Ther 5:47-61, 2016).

Some people with diabetes have macular edema, which is a swelling of the central part of the retina (the tissue that lines the back of the eye). This swelling can threaten eyesight if untreated.Injecting a drug such as a corticosteroid into the eye can help treat the condition. Sometimes this has a side effect of increasing intraocular pressure (pressure within the eye). A small or short-lived rise in eye pressure should be no cause for concern, but it is very important to ensure the pressure is not too high for too long­because this could lead to the loss of eyesight. To prevent this happening, an eye doctor needs to check the eye pressure regularly.Some people are more susceptible to this problem­for example, people who have had any problems related to eye pressure in the past or people whose eyes already have a higher than normal pressure even before treatment. People who are most susceptible may need more types of checks and more frequent checks to ensure that any problems are found and treated quickly.We have developed flowcharts that help eye doctors decide which checks are needed and how often based on what the doctor knows about the person's eye before treatment and what they see at each check-up after treatment. They help doctors make sure that everyone has check-ups at the right time and they help doctors spot any problems early so that they can be resolved before long-lasting damage can occur.

Criteria for choosing clinically effective glaucoma treatment: A discussion panel consensus.

UNLABELLED: Abstract. BACKGROUND: In the clinical management of patients at risk for or diagnosed with primary open-angle glaucoma (POAG), the aim of medical treatment is to reduce intraocular pressure (IOP) and then maintain it over time at a level that preserves both the structure and function of the optic nerve. OBJECTIVE: The objective of this report was to establish a consensus on the criteria that should be used to determine the characteristics of IOP-lowering medication. METHODS: Discussion was held among a panel of 12 physicians considered to be experts in glaucoma to develop a consensus on the criteria used by them to determine the characteristics of the IOP-lowering medication chosen for initial monotherapy and adjunctive treatment of ocular hypertension (OHT) or POAG. Consensus development combined available evidence and the impressions of these physicians regarding the clinical effectiveness of IOP-lowering medication for OHT and POAG. Once the panel identified the criteria, the order of priority and the relative importance of these criteria were then established in the setting of 3 risk categories (low, medium, and high) for a patient to experience significant visual disability from glaucoma over their expected life span. RESULTS: The panel identified 5 criteria to determine the characteristics of IOP-lowering medication for OHT and POAG: IOP-lowering effect, systemic adverse events (AEs), ocular tolerability, compliance/administration, and cost of treatment. IOP-lowering effect was consistently ranked as the highest priority and cost as the lowest. The priority of compliance/administration did not vary by clinical situation. Systemic AEs and ocular tolerability were ranked as higher priorities in initial monotherapy than in adjunctive treatment and ranked lower as the risk for visual disability increased. The priority given to the criteria used to determine clinical effectiveness varied both with the risk for functional vision loss from glaucoma and whether initial monotherapy or adjunctive treatment was being considered. CONCLUSION: Glaucoma treatment should be assessed with regard to the need not only to lower IOP but also to minimize systemic and ocular AEs, promote patient compliance, and minimize cost. The order of priority and relative importance given to these treatment criteria will vary as part of individualizing patient care.

Elevated Intraocular Pressure After Intravitreal Steroid Injection in Diabetic Macular Edema: Monitoring and Management.

INTRODUCTION: With the increasing use of intravitreal administration of corticosteroids in macular edema, steroid-induced intraocular pressure (IOP) rise is becoming an emergent issue. However, for patients in whom intravitreal steroids are indicated, there are no specific recommendations for IOP monitoring and management after intravitreal administration of corticosteroids. METHOD: An expert panel of European ophthalmologists reviewed evidence on corticosteroid-induced IOP elevation. The objective of the panel was to propose an algorithm based on available literature and their own experience for the monitoring and management of corticosteroid-induced IOP elevation, with a focus on diabetic patients. RESULTS: Data from trials including diabetic patients with a rise of IOP after intravitreal steroid administration indicate that IOP-lowering medical treatment is sufficient for a large majority of patients; only a small percentage underwent laser trabeculoplasty or filtering filtration surgery. A 2-step algorithm is proposed that is based on the basal value of IOP and evidence for glaucoma. The first step is a risk stratification before treatment. Patients normotensive at baseline (IOP ≤ 21 mmHg), do not require additional baseline diagnostic tests. However, patients with baseline ocular hypertension (OHT) (IOP > 21 mmHg) should undergo baseline imaging and visual field testing. The second step describes monitoring and treatment after steroid administration. During follow-up, patients developing OHT should have baseline and periodical imaging and visual field testing; IOP-lowering treatment is proposed only if IOP is >25 mmHg or if diagnostic tests suggest developing glaucoma. CONCLUSION: The management and follow-up of OHT following intravitreal corticosteroid injection is similar to that of primary OHT. If OHT develops, IOP is controlled in a large proportion of patients with standard IOP treatments. The present algorithm was developed to assist ophthalmologists with guiding principles in the management of corticosteroid-induced IOP elevation. FUNDING: Alimera Sciences Limited.

Preservative-free treatment in glaucoma: who, when, and why.

PURPOSE: To review and summarize the available literature on the effect of preservatives on the eye, to provide practical guidance for the clinical assessment of the ocular surface in glaucoma patients, and to define patient populations that might benefit from preservative-free topical intraocular pressure (IOP)-lowering agents. METHODS: This manuscript is based on a combination of a literature review on preservatives and the eye and expert opinion from glaucoma specialists with an interest in ocular surface disease. RESULTS: There is an increasingly recognized association between eyedrop preservatives and ocular surface disease. Preservative-free therapy is now available for a wide range of active compounds, although there are still some misconceptions regarding their appropriate use. For patients treated topically for glaucoma or ocular hypertension, a rough estimate could be that 20% may need treatment with topical IOP-reducing agents that are free from preservatives. CONCLUSION: This review provides an up-to-date account of the literature regarding preservatives and the eye, as well as suggestions and recommendations on to when to use preservative-free antiglaucoma treatment.

Visual field loss in patients with refractory partial epilepsy treated with vigabatrin: final results from an open-label, observational, multicentre study.

BACKGROUND: Use of the antiepileptic drug vigabatrin is associated with an elevated risk of visual field loss. OBJECTIVE: To determine the frequency of, and risk factors for, vigabatrin-attributed visual field loss (VAVFL) in the setting of a large-scale, multinational, prospective, observational study. STUDY DESIGN: A comparative, open-label, parallel-group, multicentre study. SETTING: Hospital outpatient clinics at 46 centres in five countries. PATIENTS: 734 patients with refractory partial epilepsy, divided into three groups and stratified by age (8-12 years; >12 years) and exposure to vigabatrin. Group I comprised patients treated with vigabatrin for > or =6 months. Group II comprised patients previously treated with vigabatrin for > or =6 months who had withdrawn from the drug for > or =6 months. Group III comprised patients never treated with vigabatrin. Patients underwent perimetry at either 4- or 6-month intervals, for up to 36 months. Visual field outcome was evaluated masked to drug exposure. INTERVENTION: Perimetry. MAIN OUTCOME MEASURE: The visual field outcome at each of four analysis points: (i) at enrolment (i.e. baseline, all patients); (ii) for patients exhibiting a conclusive outcome at the initial visual field examination; (iii) for patients exhibiting at least one conclusive outcome to the visual field examinations; and (iv) at the last conclusive outcome to the visual field examinations. RESULTS: Of the 734 patients, 524 yielded one or more conclusive visual field examinations. For Group I, the frequency of VAVFL at the last conclusive examination was 10/38 (26.3%) for those aged 8-12 years and 65/150 (43.3%) for those aged >12 years. For Group II, the respective frequencies were 7/47 (14.9%) and 37/151 (24.5%). One case resembling VAVFL was present amongst the 186 patients in Group III at the last conclusive examination. The frequency of VAVFL in Groups I and II combined was 20.0% for those aged 8-12 years and 33.9% for those aged >12 years. VAVFL was associated with duration of vigabatrin therapy (odds ratio [OR] up to 15.2; 95% CI 4.4, 51.7), mean daily dose of vigabatrin (OR up to 26.4; 95% CI 2.4, 291.7) and male gender (OR 2.51; 95% CI 1.5, 4.1). VAVFL was more frequently detected with static than with kinetic perimetry (OR up to 0.43; 95% CI 0.24, 0.75). CONCLUSIONS: Since the probability of VAVFL is positively associated with treatment duration, careful assessment of the risk-benefit ratio of continuing treatment with vigabatrin is recommended in patients currently receiving this drug. All patients continuing to receive vigabatrin should undergo visual field examination at least every 6 months for the duration of treatment. We recommend two-level (three-zone), gradient-adapted, suprathreshold static perimetry of the peripheral field together with threshold perimetry of the central field out to 30 degrees from fixation. The frequency of ophthalmological and perimetric examinations should be increased in the presence of VAVFL.