Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Miami
Group 1: pre-existing dry eye treatment regimen + sham light treatment. Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment. Group 2: pre-existing dry eye treatment regimen + pulsed light therapy (PLT) Subjects will be recruited from the outpatient clinics at Bascom Palmer Eye Institute, will have a chief complaint of dry eyes, and will have to meet all inclusion/exclusion criteria. Subjects will be randomized via computerassisted random number generation to Group 1 or 2. All subjects will undergo baseline evaluation for DES including a standardized questionnaire about symptoms of dry eyes (takes about 5 minutes to complete and assesses the presence and severity of dry eye symptoms), various testing on the properties and composition of the tear film, grading of changes related to dry eye seen on the surface of the eye, and grading of the oil glands on the eyelid (meibomian glands) and their secretions. Primary outcomes will be anatomical improvement of the meibomian glands and their secretions. Subjects in Group 1 will continue their pre-existing dry eye treatment regimen and receive sham light treatment, whereas subjects in Group 2 will continue their pre-existing dry eye treatment regimen and receive PLT. All subjects will come for their initial visit where evaluation and treatment #1 will take place. They will also attend 3 follow-up visits spaced approximately 3-4 weeks apart during which they will have subsequent treatments and/or evaluations for their dry eyes. The visit duration will range from approximately 60-90 minutes per clinic visit. The PLT devices are FDA approved for the treatment of rosacea in the periocular/facial region, and having facial rosacea is one of the inclusion criteria for this study. This is the indication for treatment with PLT. The devices are not FDA-approved for the treatment of DES, although this is something we will be looking at as one of our main outcomes.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
