TearCare in Young Adults
University of Alabama at Birmingham
Summary
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
Description
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant MGD. Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28. The primary objective is to evaluate the safety and efficacy of TearCare® in teenage and young-adult patients with MGD. A secondary objective includes a predictive analysis to determine which baseline clinical parameters best predict success with a TearCare treatment. Co-primary efficacy endpoints include change fr…
Eligibility
- Age range
- 18–29 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 years but \<30 years of age 2. Non-invasive Keratograph break-up time (NIKBUT) \<10 seconds in at least one eye 3. Meibomian gland secretion score (MGSS) ≤23 for 15 glands in at least one eyelid 4. OSDI ≥23 Exclusion Criteria: 1. Contact lens wear within two weeks of study enrollment or planned during study period 2. Habitual visual acuity worse than 0.30 logMAR (Snellen equivalent of 20/40) in either eye 3. Previous or current diagnosis of any autoimmune condition 4. Use of any of the following medications within 60 days of enrollment: 1. Topical ophthalm…
Interventions
- DeviceTearCare®
The TearCare system is designed to deliver controlled, precise heat to the tarsal plates and underlying MGs of the eyelids for 15 minutes. The TearCare system is comprised of a reusable SmartHub and single-use SmartLids. The single-use SmartLid pair comprises four flexible, sensor-controlled strips that adhere to each of the four eyelids. They contain flexible circuits, sensors, and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. The SmartLids are connected to the SmartHub. When attached to the SmartHub, the SmartLids deliver thermal energy (i.e., heat) to the eyelids. Embedded software and a closed loop sensor system ensures that the temperature delivered at the eyelids is maintained within a precise range.
Location
- University of Alabama at Birmingham, School of Optometry, Clinical Eye Research FacilityBirmingham, Alabama