Eric Sellem

Measurement of health-related quality of life with glaucoma: validation of the Glau-QoL© 36-item questionnaire

Purpose:  To validate a glaucoma‐specific health‐related quality of life (HRQoL) questionnaire: the Glau‐QoL©.

Nutritional, lifestyle and environmental factors in ocular hypertension and primary open‐angle glaucoma: an exploratory case–control study

Purpose:  To evaluate known and potential risk factors, including nutritional, lifestyle and environmental factors, differentiating patients with high‐tension primary open‐angle glaucoma (POAG) from control subjects with ocular hypertension (OHT).

Prevalence and risk factors for ocular surface disease among patients treated over the long term for glaucoma or ocular hypertension.

Purpose. To determine the prevalence of ocular surface diseases and identify risk factors in a population of patients receiving antiglaucomatous eyedrops over the long term. Methods. An observational cross-sectional study was designed to investigate ocular surface signs and symptoms using simple clinical tools. An ocular surface disease intensity score was calculated based on 10 questions regarding ocular surface symptoms and signs with a 4-grade scale. Patients were classified into 3 groups (A, B, and C) according to this total score. A multinomial logistic regression was performed in order to identify risk factors for surface disease. Results. In an overall population of 516 patients, 49% belonged to group A, 30% to group B, and 21% to group C. The multivariate analysis showed that the following factors were correlated with the severity of ocular surface disease: patient age, number of daily eyedrops, past topical treatment changes for ocular intolerance (found in the history of 40% of the patients), intraocular pressure (found to be significantly higher in patients with more severe ocular surface disease), and glaucoma severity. Conclusions. Patients treated for primary open-angle glaucoma or ocular hypertension often have ocular surface diseases, more often and more severely in older patients receiving more drugs and presenting with more severe glaucoma. These high prevalence values might therefore have consequences on the burden of the disease in terms of adherence to treatment and quality of life.

Cyclocoagulation of the Ciliary Bodies by High-Intensity Focused Ultrasound: A 12-Month Multicenter Study

PURPOSE To evaluate the safety and efficacy of high-intensity focused ultrasound (HIFU) cyclocoagulation in reducing intraocular pressure (IOP) in patients with refractory glaucoma by using a novel miniaturized delivery device (EyeOP1). METHODS We conducted a 12-month open-label multicenter prospective study (EyeMUST1 Study). Patients with primary (primary open-angle glaucoma [POAG]) or secondary refractory glaucoma were treated in two groups depending on the duration of each ultrasound shot (group 1: 4 seconds; group 2: 6 seconds). The primary efficacy outcome was based on IOP reduction at 6 and 12 months. RESULTS Fifty-two patients were enrolled: 36 (69%) had POAG and 16 (31%) had secondary glaucoma. Group 1 (n = 24) and group 2 (n = 28) had similar demographics and baseline characteristics. In group 1, IOP was reduced from a mean preoperative value of 29.7 ± 7.7 mm Hg (n = 3.5 glaucoma medications) to a mean postoperative value of 21.3 ± 6.7 mm Hg (n = 3.5 glaucoma medications) and 20.1 ± 6.7 mm Hg (n = 3.2 glaucoma medications) at 6 and 12 months, respectively. In group 2, IOP was reduced from a mean preoperative value of 29.0 ± 7.4 mm Hg (n = 3.3 glaucoma medications) to a mean postoperative value of 20.2 ± 7.4 mm Hg (n = 3.4 glaucoma medications) and 18.5 ± 6.6 mm Hg (n = 3.5 glaucoma medications) at 6 and 12 months, respectively. At 12 months, the IOP reduction was sustained in both groups (32% IOP reduction in group 1 and 36% IOP reduction in group 2). The overall tolerance of the technique was good, with no serious adverse events. CONCLUSIONS The new miniaturized HIFU EyeOP1 delivery device seems to be effective in decreasing IOP in patients with refractory glaucoma. The technology offers a good safety profile. (ClinicalTrials.gov number, NCT01338467.).

Xal-Ease: impact of an ocular hypotensive delivery device on ease of eyedrop administration, patient compliance, and satisfaction.

Purpose To measure the impact of the Xal-Ease® delivery device on ease of eyedrop administration and on treatment compliance and satisfaction. Methods This prospective, multicenter, randomized, comparative, crossover study was conducted at 43 sites in France. Eligible subjects were >18 years of age, were diagnosed with primary open-angle glaucoma or ocular hypertension, had been treated with latanoprost or fixed-combination latanoprost/timolol for ≥3 months prior to enrollment, and did not require a therapy change. Subjects used either Xal-Ease or the dropper bottle for 4 weeks and then switched to the alternate delivery method for the next 4 weeks. Subjects completed questionnaires after 1 and 4 weeks in each treatment period. Results In all, 211 subjects were enrolled, 107 to the Xal-Ease/dropper bottle group and 104 to the dropper bottle/Xal-Ease group. Baseline demographic and ocular characteristics were similar. Use of Xal-Ease made it significantly less likely that the subject would need someone to help with drop instillation (6.9% vs 18.1%, respectively; p<0.001) and reduced the problem of the tip of the bottle touching the eye (3.2% vs 35.6%, respectively; p<0.001). Reported compliance rates were very high and similar across groups during both treatment periods. After 1 month of use during both treatment periods, more than 70% of subjects reported global satisfaction with Xal-Ease to their physicians. No adverse events associated with the use of Xal-Ease were noted. Conclusions Xal-Ease generally makes administration of latanoprost or fixed-combination latanoprost/timolol easier compared with the dropper bottle.

Prévalence et description du traitement par hypotonisants pour glaucome et hypertonie oculaire en France

Objectif L’objectif de cette etude est d’estimer la prevalence du traitement par hypotonisants pour glaucome ou hypertonie intra-oculaire (HTIO) chez les sujets de 40 ans ou plus residant en France metropolitaine, et de decrire les modalites therapeutiques, l’observance et la qualite de vie des sujets traites. Methodes Il s’agit d’une etude telephonique realisee sur la population generale aupres d’un echantillon representatif de 5 726 personnes au cours de l’annee 2004. Les sujets traites par hypotonisants pour glaucome ou HTIO ont ete definis comme ceux declarant utiliser des gouttes pour les yeux depuis plus d’un mois et citant au moins l’une des 52 specialites hypotonisantes repertoriees et/ou declarant savoir prendre ces gouttes pour un glaucome ou une hypertension oculaire. La qualite de vie etait mesuree par le questionnaire GlauQOL-17. Resultats Au total, 237 sujets (4,1 %) correspondaient a cette definition. La prevalence augmentait avec l’âge, variant de 0,7 % chez les 40-44 ans a 10,6 % chez les plus de 80 ans. Apres standardisation sur l’âge, elle etait plus elevee en Ile-de-France (5,3 %), en Mediterranee (4,5 %) et dans le Sud-Ouest (4,7 %), et plus faible dans les communes rurales (3,2 %) et chez les personnes sans diplomes (2,9 %). Les beta-bloquants (49,5 %) et les prostaglandines (37,4 %) constituaient les traitements les plus frequents, devant les inhibiteurs de l’anhydrase carbonique (15,3 %), les sympathomimetiques (5,7 %) et les myotiques (1,3 %). L’observance n’etait pas totale pour 39 % des patients (22 % de ceux ne devant instiller qu’une goutte par jour). Discussion Les resultats de cette etude sont concordants avec les chiffres des autorites de sante et les resultats de l’Etude Francaise Glaucome et Hypertonie oculaire 1 Jour. La plus faible prevalence observee dans les regions a faible densite medicale, a faible niveau socio-economique et en milieu rural suggere qu’il puisse exister un sous-diagnostic du glaucome et de l’hypertonie oculaire. Conclusion Sur la base de cette premiere etude a l’echelle nationale, on estime la prevalence en France des personnes recevant un traitement hypotonisant pour glaucome ou HTIO a environ 1,2 million. Le nombre de gouttes a instiller semble avoir un retentissement sur l’observance du traitement.

Predictors of additional intraocular pressure reduction in patients changed to latanoprost/timolol fixed combination.

BackgroundGiven the growing number of ocular hypotensive medications available, it is important to be able to predict a positive response to therapy. The purpose of the present study was to identify predictors of an additional 10% intraocular pressure (IOP) reduction after 12 weeks of treatment with latanoprost/timolol fixed combination (FC) in patients requiring a change in their previous ocular hypotensive medication.MethodsThis multicenter, open-label, prospective, phase IIIb study included subjects ≥18 years of age with open-angle glaucoma (OAG) or ocular hypertension (OHT). Eligible subjects had baseline IOP ≥21 mmHg and insufficient response to current beta-blocker monotherapy. The primary efficacy analysis (logistic regression) identified predictors of a positive response after 12 weeks of latanoprost/timolol FC.ResultsThe intent-to-treat (ITT) population included 383 subjects treated with ≥1 drop of FC and having ≥1 follow-up IOP assessment. Mean IOP was 22.19 ± 2.16 mmHg at baseline and was reduced by 5.42 ± 2.71 mmHg at study end. In all, 325 (84.9%) subjects had a positive response to latanoprost/timolol FC; the response rate was similar across groups: OAG (n = 208; 82.7%); OHT (n = 161; 87.6%); OAG+OHT (n = 14; 85.7%). Higher baseline IOP (odds ratio: 1.284; 95% confidence interval [CI]: 1.101, 1.497; p = 0.0014) and absence of adverse events (odds ratio: 0.318; 95% CI: 0.161, 0.629; p = 0.0010) were significant predictors of positive response. Age, gender, ethnic origin, diagnosis, family history of OAG/OHT, corneal thickness, and concomitant systemic beta-blocker were not significant predictors of a positive response in the ITT analysis. The FC was well tolerated. The most common adverse events were related to the eye and were consistent with known adverse events associated with latanoprost and timolol.ConclusionsThese results support the use of latanoprost/timolol FC in patients whose IOP is insufficiently controlled on beta-blocker monotherapy. Patients with higher baseline IOP levels and who do not experience adverse events while on therapy are most likely to achieve a positive response to latanoprost/timolol FC.Trial RegistrationStudy registration number: NCT00230763

Ultrasound Circular Cyclo-Coagulation – Innovation in Glaucoma with High Intensity Focused Ultrasound

Existing treatment modalities for glaucoma, including pharmacological therapy, lasers, surgery and shunts, are all associated with shortcomings. Ultrasonic coagulation of the ciliary body with pinpoint precision using high intensity focused ultrasound (HIFU) enables significant reduction of aqueous inflow and intraocular pressure (IOP). Energy is focused through non-optically transparent media with controlled energy absorption, reducing effects on adjacent tissues. Energy deposition and tissue heating at the focus site do not depend on tissue pigmentation, thus improving predictability. Currently, high-frequency miniaturised transducers create small focal zones for improved treatment area targeting, and ultrasound focusing provides enhanced control. The high operating frequency allows a sharp transition between the focal zone and the untreated area, reducing risks of heating adjacent healthy tissue. Such transducers are used extensively in malignant tumour treatments. Novel Ultrasound Circular Cyclo-Coagulation (UC3) with a miniaturised annular transducer uses HIFU technology. The circular geometry of the device allows precise, constant and reproducible positioning. Results from animal studies and from a clinical pilot study of patients with refractory glaucoma indicate that ultrasonic coagulation of the ciliary body using HIFU delivered by a circular miniaturised transducer is an effective and well-tolerated method of reducing IOP. The single-step procedure is short, easy to perform and accurate. Glaucoma impacts patients’ quality of life, including unpleasant treatment side effects and social and physical aspects. Gold-standard trabeculectomy shortcomings highlight the need for precise, focused surgical modalities. HIFU is a non-invasive, cost-effective innovation that, should the multicentre clinical trial demonstrate similar results to the preclinical and pilot studies, will be a useful addition to current glaucoma management techniques.

Is the Optic Nerve Head Structure Impacted by a Diagnostic Lumbar Puncture in Humans

Purpose: The purpose of this study is to assess in vivo whether diagnostic lumbar puncture (LP) is followed by optic nerve head (ONH) and parapapillary anatomic changes in normal human eyes. Materials and Methods: Prospective, single-center, observational case series. ONH structures (prelaminar tissue surface, anterior surface of the lamina cribrosa, central retinal vessels) and parapapillary structures (internal limiting membrane, posterior surfaces of retinal nerve fiber layer and Bruch membrane/retinal pigment epithelium complex, Bruch membrane opening, posterior surface of the choroid) were quantitatively evaluated by means of swept-source optical coherence tomography (Triton Ver.10.05, Topcon, Tokyo, Japan) before and after LP (5, 60, and 360 min). Each of these structures was manually delineated for measurement before being superimposed to detect any displacement, using peripheral margins of parapapillary structures as a reference plane. Results: A total of 16 eyes of 8 nonglaucomatous patients were evaluated. The CSF volume was median (IQR), 1.65 mL (1.16 to 2.00) and none of the ONH structures showed any anatomic changes at any time point after LP. Conclusions: According to the design of this study, diagnostic LP is a safe procedure regarding deep ONH structures in nonglaucomatous subjects.

Ultrasonic Circular Cyclo Coagulation in patients with Primary Open-Angle Glaucoma: a Multicenter Clinical Trial

Purpose To evaluate the efficacy and safety of the Ultrasonic Circular Cyclo Coagulation (UC3) procedure in patients with primary open-angle glaucoma (POAG). Methods Prospective multicenter clinical trial. 42 eyes of 42 patients with POAG, intraocular pressure (IOP) > 21 mmHg, an average of 1.65 failed previous surgeries and an average of 3.2 hypotensive medications were insonified with a probe comprising 6 piezoelectric transducers. 18 patients (group 1) were treated with a 4 seconds exposure time for each shot and 24 patients (group 2) with a 6 seconds exposure time. Follow-up visits were performed at 1 day, 1 week, 1, 2, 3, 6 and 12 months after. Results IOP was significantly reduced in both groups (p 20%) was achieved in 12 of 18 (67%) eyes of the group 1 and in 17 of 24 (71%) eyes of the group 2. Four patients were re-treated. No major intra- or post-operative complications occurred. Conclusion UC3 seems to be an effective and well-tolerated method to reduce intraocular pressure in patients with POAG. Commercial interest