Abstract
Purpose: :
To evaluate the change in meibomian gland (MG) function after a single treatment with the LipiFlow, a treatment device designed to remove MG obstruction and evacuate MG contents.
Methods: :
Eligible patients recruited for an IRB approved clinical study were fully consented and enrolled (n=12; 7 females; 5 males). Inclusion criteria included: dry eye symptoms recorded on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire ≥ 6 in each eye and an MG score ≤ 12 on both eyes (maximum score = 45 if all glands are functional). To prevent other dry eye/ MGD treatments confounding the data, patients were required to adhere to a washout period of two weeks prior to baseline. The level of obstructive MGD was determined using a standardized instrument which exerts ~0.3 PSI over the MGs of the lower lid. Five glands in each third of the lower lid (total for each lid = 15 glands) were evaluated and scored. After baseline measurements were collected, all enrolled patients received a single 12-minute treatment with the LipiFlow treatment device. Patients were required to return for a follow-up visit 1-month post treatment to assess any improvement in the baseline measurements subsequent to treatment. During the clinical trial no other treatments or home therapies for dry eye or MGD were permitted with the exception of artificial tears and dietary supplements. Data are presented for right eyes only.
Results: :
The mean age = 46.5±16.9 yrs (range = 24-51). The mean symptom score at baseline = 17.4±4.5. One month post treatment the score was significantly lower = 11.9±5.3 (p<0.0001). The mean MG score at baseline = 4.5±3.0. One month post treatment the score was significantly higher = 18.1±8.1 (p = 0.0003).
Conclusions: :
These data indicate significant improvement in both the objective MG score and subjective dry eye symptom score. The significant improvement in MG score subsequent to a single 12-minute LipiFlow treatment indicates a restoration of MG function. This restoration of MG function occurred in conjunction with a significant reduction in dry eye symptoms providing further support for the critical role that MGs play in the maintenance of a healthy ocular surface.
Keywords: cornea: tears/tear film/dry eye