Abstract
Purpose: :
Eyelid edema can be caused by a variety of different ocular inflammatory pathologies and can lead to vision obstruction as well as quality of life problems. At the request of the FDA comparable clinician objective and patient subjective efficacy variables using appropriate methodologies had to be developed. However, the highly variable and patient specific nature of eyelid edema makes the development of clinician grading scales problematic. Studies assessing allergic eyelid edema have shown the patient to be capable of effectively grading their own edema, based on familiarity with their appearance. However, clinician grading using standardized scales has failed, even with the aid of reference photographs. This study was performed in an effort to develop a standardized clinician grading scale using reference panoramic videography of the eyelids, a more sensitive technique than photography, in a population of subjects with morning eyelid edema.
Methods: :
A segmented map of regions and features was created to identify changes in eyelid structure and swelling. Forty subjects with self-reported morning eyelid swelling were observed in the late afternoon and videos of their eyelids were recorded using high definition panoramic videography. The subjects were instructed to follow their routine nightly activities and to alert the staff when they awoke. Recordings were taken immediately upon awakening and every hour for 6 consecutive hours after. The videography was then graded between time points in a masked manner by individual clinicians using the new scale.
Results: :
The 4 point scale demonstrated that individual clinicians, through their masked grading, could identify an increase in eyelid edema from baseline. There was an average increase of 2.25 followed by a reduction of 1.25 (p=0.013) by 6 hours post awakening.
Conclusions: :
This new objective videography based grading scale visually quantifies how eyelid edema increases while subjects are asleep and decreases over the course of the day. With this instrument, it is now possible to try different interventions that can reduce existing eyelid edema, or possibly prevent it altogether.
Keywords: eyelid • edema • imaging/image analysis: clinical