Thermal Massager vs Artificial Tears to Treat Dry Eye
Thermal Massager vs Artificial Tears to Treat Dry Eye
The study was designed to confirm the effectiveness and safety of thermal massage and its superiority to artificial tears in treating dry eye syndrome. This multicentre trial was conducted in two clinical research centres of South Korea from November to March 2010–2011: Pusan National University Hospital and Busan Baik Hospital. The study design was approved by the institutional review board of the participating centres and the Korean Food and Drug Administration (No 09-ST-NE5800-0901).
Patients aged 19–80 years with aggravated dry eye symptoms were recruited. Eligibility criteria were based on the following ophthalmological tests: (1) one or more dry eye-related ocular symptoms such as dryness, irritation and burning sensations; (2) an Ocular Surface Disease Index (OSDI) score of ≥20; and (3) a tear film break-up time (BUT) of <5 s or a Schirmer I test (with application of a local anaesthetic) value <10 mm for 5 min. Participants with several conditions were excluded from the study: (1) active eye inflammation; (2) extensive conjunctival injuries affecting dry eye; (3) ocular surgery within 3 months before the study took place; (4) diabetic retinopathy, age-related macular degeneration, glaucoma, or any other ocular disease that can influence visual acuity, except senile cataract; (5) a history of wearing contact lenses; (6) a risk of retinal detachment such as high myopia, lattice degeneration and retinal break and (7) a history of active treatment for dry eyes such as punctal occlusion or the usage of anti-inflammatory eye drops (topical steroid or topical ciclosporin) within 1 month of the study.
Written informed consent was obtained from all participants, who were then randomly assigned to either the thermal massager group or the artificial tears group.
Materials and Methods
The study was designed to confirm the effectiveness and safety of thermal massage and its superiority to artificial tears in treating dry eye syndrome. This multicentre trial was conducted in two clinical research centres of South Korea from November to March 2010–2011: Pusan National University Hospital and Busan Baik Hospital. The study design was approved by the institutional review board of the participating centres and the Korean Food and Drug Administration (No 09-ST-NE5800-0901).
Patients aged 19–80 years with aggravated dry eye symptoms were recruited. Eligibility criteria were based on the following ophthalmological tests: (1) one or more dry eye-related ocular symptoms such as dryness, irritation and burning sensations; (2) an Ocular Surface Disease Index (OSDI) score of ≥20; and (3) a tear film break-up time (BUT) of <5 s or a Schirmer I test (with application of a local anaesthetic) value <10 mm for 5 min. Participants with several conditions were excluded from the study: (1) active eye inflammation; (2) extensive conjunctival injuries affecting dry eye; (3) ocular surgery within 3 months before the study took place; (4) diabetic retinopathy, age-related macular degeneration, glaucoma, or any other ocular disease that can influence visual acuity, except senile cataract; (5) a history of wearing contact lenses; (6) a risk of retinal detachment such as high myopia, lattice degeneration and retinal break and (7) a history of active treatment for dry eyes such as punctal occlusion or the usage of anti-inflammatory eye drops (topical steroid or topical ciclosporin) within 1 month of the study.
Written informed consent was obtained from all participants, who were then randomly assigned to either the thermal massager group or the artificial tears group.