None listed
Conditions
Brief summary
Dry eye disease is a highly prevalent, chronic ocular condition resulting in symptoms of discomfort and loss of quality of life for up to 1 in 3 individuals. Meibomian gland dysfunction is the most common cause of dry eye disease and requires lid warming as a component of its management. Traditional microwave-heated warm compresses may be superseded by electronically heated warm compresses. This prospective, randomised investigator-masked controlled clinical trial seeks to evaluate the performance of a electronically heated eye mask relative to a conventional microwave heated mask in improving symptoms and clinical signs of meibomian gland dysfunction,
Interventions
Study intervention: The participant will apply a USB electronically-heated eye mask (Meibocare, New Zealand), to their own closed eyelids for 10-20 minutes (according to manufacturer instructions), twice daily, for 6 weeks. The target temperature during mask wear is 40 degrees Celsius which is anticipated to be reached in approximately 2 to 5 minutes. After applying heat for up to 20 minutes as instructed, the mask is removed. This is then followed by gentle digital eyelid massage which involves
Study intervention: The participant will apply a USB electronically-heated eye mask (Meibocare, New Zealand), to their own closed eyelids for 10-20 minutes (according to manufacturer instructions), twice daily, for 6 weeks. The target temperature during mask wear is 40 degrees Celsius which is anticipated to be reached in approximately 2 to 5 minutes. After applying heat for up to 20 minutes as instructed, the mask is removed. This is then followed by gentle digital eyelid massage which involves participants looking down first of all, and using their index fingers orientated horizontally to roll downwards over the upper eyelid from top to bottom 5 times, over about 10 seconds, both eyes at the same time to help express the oils at the eyelid margin. This process is repeated for the lower eyelids, during participant up-gaze, with the horizontal index finger, applied in a rolling motion from bottom to top, 5 times to the lower eyelids. Participant compliance with twice daily application of the heated mask followed by massage will be recorded in a participant diary.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 18 years or older - Symptomatic of dry eye disease - Clinical signs of meibomian gland dysfunction (MGD) - Normal eyelid architecture - Willing and able to follow the protocol - Willing to not wear contact lenses (CL) or apply any eye drops within 12 hours of the study visits
Exclusion criteria
- Use of contact lenses within 12 hours of study visits - Active ocular allergy - Refusal to be advised of incidental findings - Current or planned pregnancy or lactation during the study - Ocular surgery or dermatological treatments in the previous three months or planned during the study period - History of ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of study participation - An ocular or systemic disorder or condition, current treatment, disease or trauma judged by the investigator to be incompatible with participation in the study
Outcome results
None listed