Abstract
Purpose :
Morning eyelid congestion (MEC) is characterized by significant redness and lid swelling due to natural, age-related changes in the lid tissues and the presence of subacute inflammatory mediators in the closed-eye tear film. MEC is most apparent upon awakening and decreases as the day progresses. Due to its episodic frequency and limited duration, MEC has been difficult to study. Previous attempts to study MEC involved Phase 1 units for monitoring of subjects immediately upon awakening. However, broader screening is needed to identify subjects with moderately severe signs and symptoms. To this aim, we developed an Electronic Diary Photography System called myLid diary for subject reporting of MEC-related redness and swelling.
Methods :
22 subjects were enrolled in a 3-Visit observational study conducted over a 3 week period: 1 week of diary run-in, followed by 2 weeks of environmental assessments. At Visit 1 (Day 1) subjects received the myLid system and were instructed to assess lid swelling and redness for 1-week (Day 1-6) at the following time-points: in the evening (before bed), upon awakening, at 30 minutes after awakening, and hourly thereafter for 6 hours. At Visit 2 (Day 7) a trained clinician verified the presence of morning eyelid swelling from myLid diary images and qualified patients continued the at-home diary assessments (Days 7-20). At Visit 3 (Day 21) subjects underwent study exit procedures.
Results :
Signs significantly increased from before-sleep scores to upon awakening scores using the lid swelling severity scale (P<0.001), the VAS scale (P<0.001) and the ocular redness scale (P<0.001). By hour 6 after wakening, signs had returned to close to baseline. The average range of morning eyelid severity was 1.7 to 3.3 upon awakening, and 0.84 to 2.45 at the 6-hour time point.
Conclusions :
Lid swelling upon awakening was significantly higher than the previous evening, demonstrating a clear diurnal pattern. MEC is a significant ocular condition that warrants attention. This tracking technology provides an appropriate method for studying therapies targeted at severe episodes of MEC.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.