S Doan1, F Chiambaretta2, C Baudouin3. 1. Service d'ophtalmologie, hôpital Bichat, 46, rue Henri-Huchard, 75018 Paris, France; Fondation A de Rothschild, 25-29, rue Manin, 75019 Paris, France. Electronic address: serge.doan@noos.fr. 2. Service d'ophtalmologie, hôpital Gabriel-Montpied, CHU de Clermont-Ferrand, 58, rue Montalembert, 63000 Clermont-Ferrand, France; EA 7281 - R2D2, université d'Auvergne, place Henri-Dunant, 63001 Clermont-Ferrand, France. 3. Centre national d'ophtalmologie des quinze-vingts, 28, rue de Charenton, 75571 Paris cedex 12, France; Inserm UMRS968, institut de la vision, université Pierre-et-Marie-Curie, 17, rue Moreau, 75012 Paris, France; Hôpital Ambroise Paré, AP-HP, université de Versailles St-Quentin, 9, avenue Charles-de-Gaulle, 92100 Boulogne, France.
Abstract
INTRODUCTION: Eyelid hygiene, including massage and warm compresses, is an important part of the treatment and prevention of Meibomian gland dysfunction (MGD). Although effective, it requires active participation of the patient and lacks standardisation. Blephasteam is a medical device designed to warm and humidify the eyelid with heating glasses, in order to liquify meibum, thus relieving symptoms and preventing relapse. MATERIALS AND METHODS: The ESPOIR study (Evaluation of the Satisfaction of Patients with Management of Ocular Surface Diseases) presented herein was designed to evaluate the safety and efficacy of this medical device in patients with MGD. A total of 28 French centers participated in the study. One hundred and two patients presenting with symptomatic dysfunction or Meibomian-related dry eye underwent two sessions per day with the eyelid warming device and recorded diary entries on a number of parameters every 2 days for the first week and then weekly for the remaining 2 weeks. Patients were assessed on days 0 and 21. RESULTS: Symptomatology, as recorded on a visual analogue scale (VAS) by the investigator (the primary efficacy variable) was significantly (P<0.001) improved at the end of the study (59.97, 95% CI 55.64-64.30 vs. 39.71, 95% CI 34.78-44.65 on Days 0 and 21 respectively), as was the mean symptoms score (mean decrease of 19.93 ± 22.15 VAS units; P<0.001), hyperemia score (-1.57 ± 1.96 and -1.45 ± 1.85; P<0.001, in the worse and contralateral eye respectively), and quality of meibum (mean -4.03 ± 3.08; P<0.001 and -3.32 ± 3.20; P<0.01, in the worse and contralateral eye respectively). More than twice as many reported their symptoms had improved or disappeared compared with those whose symptoms had not changed or had worsened. Global symptomatology, as assessed by the patients, declined throughout the study, and a large majority of patients were satisfied or very satisfied with the treatment. Clear vision and blinking were not impaired during use of the eyelid warming device, which insures proper spreading of the tear film, and patients were able to continue daily activities such as reading and watching television. No adverse events were reported, and there were no changes in intraocular pressure or visual acuity. Safety was rated as satisfactory or very satisfactory by more than 95% of the investigators. CONCLUSION: The study suggests that the eyelid warming device is safe and effective in reducing ocular discomfort and symptoms in MGD.
INTRODUCTION: Eyelid hygiene, including massage and warm compresses, is an important part of the treatment and prevention of Meibomian gland dysfunction (MGD). Although effective, it requires active participation of the patient and lacks standardisation. Blephasteam is a medical device designed to warm and humidify the eyelid with heating glasses, in order to liquify meibum, thus relieving symptoms and preventing relapse. MATERIALS AND METHODS: The ESPOIR study (Evaluation of the Satisfaction of Patients with Management of Ocular Surface Diseases) presented herein was designed to evaluate the safety and efficacy of this medical device in patients with MGD. A total of 28 French centers participated in the study. One hundred and two patients presenting with symptomatic dysfunction or Meibomian-related dry eye underwent two sessions per day with the eyelid warming device and recorded diary entries on a number of parameters every 2 days for the first week and then weekly for the remaining 2 weeks. Patients were assessed on days 0 and 21. RESULTS: Symptomatology, as recorded on a visual analogue scale (VAS) by the investigator (the primary efficacy variable) was significantly (P<0.001) improved at the end of the study (59.97, 95% CI 55.64-64.30 vs. 39.71, 95% CI 34.78-44.65 on Days 0 and 21 respectively), as was the mean symptoms score (mean decrease of 19.93 ± 22.15 VAS units; P<0.001), hyperemia score (-1.57 ± 1.96 and -1.45 ± 1.85; P<0.001, in the worse and contralateral eye respectively), and quality of meibum (mean -4.03 ± 3.08; P<0.001 and -3.32 ± 3.20; P<0.01, in the worse and contralateral eye respectively). More than twice as many reported their symptoms had improved or disappeared compared with those whose symptoms had not changed or had worsened. Global symptomatology, as assessed by the patients, declined throughout the study, and a large majority of patients were satisfied or very satisfied with the treatment. Clear vision and blinking were not impaired during use of the eyelid warming device, which insures proper spreading of the tear film, and patients were able to continue daily activities such as reading and watching television. No adverse events were reported, and there were no changes in intraocular pressure or visual acuity. Safety was rated as satisfactory or very satisfactory by more than 95% of the investigators. CONCLUSION: The study suggests that the eyelid warming device is safe and effective in reducing ocular discomfort and symptoms in MGD.
Authors: Jonatan Olafsson; Xiaoran Lai; Erlend Christoffer Sommer Landsend; Snorri Olafsson; Eric Parissi; Øygunn A Utheim; Sten Raeder; Reza A Badian; Neil Lagali; Darlene A Dartt; Tor P Utheim Journal: Sci Rep Date: 2021-11-17 Impact factor: 4.379