N/A N=34 Randomized Treatment

Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

Blepharitis · Dry Eye Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01808560 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Mean Change in Total Meibomian Gland Score — 12.8; 1.9 Change in Meibomian Gland Score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LipiFlow Pre-Treatment (Device); LipiFlow Post-treatment (Device)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: TearScience, Inc.
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Total Meibomian Gland Score	12.8; 1.9	—
SECONDARY Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months	-3.4; 1.2	—

Summary

The purpose of this pilot feasibility study is to assess whether treating meibomian gland dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual quality and ocular comfort after cataract surgery.

Eligibility Criteria

Inclusion Criteria

55 to 85 years of age
Must be able to comply with protocol including study randomization; completion of planned bilateral cataract surgery; no use of other MGD or dry eye treatments during the study; and attendance at all study visits
Meibomian gland dysfunction in both eyes based on total meibomian gland score
None to mild dry eye symptoms based on Ocular Surface Disease Index score
Tear film interferometry assessment of 100 units or less

Exclusion Criteria

Systemic disease conditions that causes dry eye
Use of systemic medications known to cause dry eye
Use of other MGD or dry eye treatments except for over the counter lubricants or dietary supplements
History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
Participation in another ophthalmic drug or device trial in the past month

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01808560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.