Study Design
A cross-sectional epidemiologic survey was performed on patients presenting for routine ophthalmologic consultations at clinics or hospitals in Belgium, Denmark, France, Germany, The Netherlands, Poland, Portugal, Russia, Spain, Turkey, and Ukraine.
Subjects
Participating ophthalmologists were required to recruit at least ten consecutive patients presenting to their clinic regardless of the reason for the consultation. Adult patients aged 18–99 years were included in this study. There were no specific exclusion criteria other than inability or unwillingness to give informed consent.
Recruitment of Investigators
Ophthalmologists were identified from national databases and the numbers included per country adjusted to maintain proportionality. The first 349 qualifying ophthalmologists who agreed to participate in the study were selected to recruit patients.
Study Setting
The study was conducted in the context of a routine ophthalmic patient visit.
Ethical Considerations
The guidelines of Good Epidemiological Practice were followed, and this study conformed to the principles of the Declaration of Helsinki [12]. The International Conference of Harmonization (ICH) rules were not applicable as no patient interventions or management was performed specifically for this study.
Approval from local or national ethics committees was obtained according to the regulations in each country [France: Comité consultatif sur le traitement de l’information en matière de recherche (C.C.T.I.R.S.); Ukraine: Ethics Committees at Medical Centre “Eurozir” (Zaporizhzya), at LLC “Vzgliad” MC” (Dnipropetrovsk), at Pyrogov Vinnytsya Regional Clinical Hospital (Vinnytsya), at the Centre of Modern Ophthalmology “Your Vision” (Chernivtsi), at LLC “Polymed Zakhid” (Lviv), at PI “Regional Clinical Hospital-Centre of Emergency Medical Care and Disaster Medicine”* (Kharkiv), at MI “City Polyclinic No. 29” (Odessa); Poland: Komiska Etyki Lubelska Izba Lekarska (Lublin); Spain: Comité ético de investigación clínica (Madrid); Belgium: Comité Local d’Ethique Hospitalier CHU Saint-Pierre (Brussels); Russia: Independent Interdisciplinary Committee for the Ethical Examination of Clinical Research (Moscow); Turkey: Ministry of Health (Türkiye Cumhuriyeti Sağlık Bakanlığı); The Netherlands: not subject to Medical Research Involving Human Subjects Act and ethics review (Rotterdam); German: Ethics Committees of the German Medical Association ‘Landesärztekammer’ (Baden-Württemberg, Bayern, Brandenburg, Hessen, Rheinland-Pfalz, Sachsen) and ‘Ärztekammer’ (Berlin, Bremen, Hamburg, Niedersachsen, Nordrhein, Saarland, Schleswig-Holstein, Westfalen-Lippe). There was no regulatory process required for other countries because this was an observational study.] This study required no additional investigations, outside of those normally performed for a routine ophthalmologic consultation or required by clinical findings during the consultation.
Prior to data collection, all patients underwent a thorough informed consent procedure that explained the nature and purpose of the study and the use of their data. Approval from data protection organizations was not required because no direct or indirect personally identifiable data were collected.
Primary Objective
The primary objective of the study was to determine the prevalence of eyelid disorders in a population of general ophthalmology patients.
Secondary Objectives
Secondary objectives were to evaluate for associations between eyelid disorders and ocular surface pathology, to assess the impact of eyelid disorders on patient quality of life and to determine the current strategy among ophthalmologists for treating eyelid disorders in routine practice.
Procedure
During the course of ophthalmic consultation, the investigator completed a questionnaire for each patient enrolled in the study. An ocular surface examination was also performed. Tests such as Schirmer’s test, tear break-up time and slit-lamp examination were performed as clinically warranted. Data were collected on the impact of ocular symptoms on the daily living activities of the patients. The intended management plan was noted for any pathology identified during the consultation.
Clinical Examinations
Eyelid and Meibomian Gland Examination
A patient was diagnosed with an eyelid disorder if at least one of the following clinical signs were present: abnormal position of eyelids (entropion, ectropion, floppy eyelids); abnormal eyelashes (sparse, trichiasis, distichiasis, madarosis, cylindrical dandruff); abnormal eyelid margin (desquamation and crusting, telangiectasia, thickening, irregularities, whitish foam, fatty secretions, pigmentation, inflammation/swelling, meibomian gland obstruction); unclear secretions with pressure was applied to the meibomian gland (cloudy secretion, toothpaste-type secretion, secretion not expressed); miscellaneous abnormalities such as stye, chalazion and concretions.
Ocular Surface Examination
The ocular surface was examined, and a slit-lamp examination with staining was performed if clinically required. Investigators specifically noted the presence of hyperemia, follicles, papillae and concretions. Corneal examination was performed with specific reference to ulceration, filaments, superficial punctate keratitis and pannus.
Schirmer’s Test and Tear Break-Up Time
Schirmer’s test and tear break-up time were performed according to the clinician’s normal practice and clinical need. Schirmer’s test was scored as normal or abnormal (< 10 mm in 5 min). Tear break-up time was scored as normal or abnormal (< 10 s).
Symptoms
The questionnaire included specific queries on the presence of red eye; burning/stinging sensation; irritation with foreign body sensation; itching; tearing in the morning or during the day; dry eye sensation; sensitivity to light; dry, rough eyelid skin; discomfort on opening and closing eyelids; blurred vision. These signs and symptoms were rated on a 4-point scale as follows: 0 = none; 1 = present but not disturbing; 2 = disturbing; 3 = very disturbing.
Questionnaire items also recorded the degree of impact of symptoms on vision, daily activities and work, leisure, use of contact lenses, emotions and sleep. The degree of impact was scored as slight, moderate or severe.
Statistical Methods
Sample size calculations estimated an expected prevalence of eyelid disorders of 60–70% and a target precision of about 4%. Power calculations suggested that 539 patients were required for the primary variable. However, ten classes of ocular history were being considered in this study (rosacea, atopic dermatitis, seborrheic dermatitis, dry eye, age-related macular degeneration, glaucoma, diabetes, cataract, allergy and MGD); hence, a patient sample size of approximately 5390 was planned. Each investigator was required to enroll 10 consecutive patients, and a 20% rate of inactivity or under-enrollment by investigators led to a target of recruiting 647 ophthalmologists.
Statistical associations were evaluated for the incidence of MGD and the presence of eyelid disorders, clinical signs of eyelid disorders and ocular surface disorders. The chi-square test or Fischer’s exact test were used as appropriate. P < 0.05 was considered statistically significant.