Status:
COMPLETED
Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery
Lead Sponsor:
TearScience, Inc.
Conditions:
Blepharitis
Dry Eye Syndrome
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief 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 ...
Detailed Description
This is a post-market, prospective, non-significant risk, open-label, randomized multi-center clinical trial evaluating treatment with the LipiFlow System in patients with meibomian gland dysfunction ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01808560
Start Date
March 1 2013
End Date
January 1 2015
Last Update
September 4 2018
Active Locations (7)
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1
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States, 60169
2
Jackson Eye
Lake Villa, Illinois, United States, 60046
3
Charles River Eye Associates
Winchester, Massachusetts, United States, 01890
4
Associated Eye Care
Stillwater, Minnesota, United States, 55082