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NOT YET RECRUITING
NCT07579156
NA

TearCare in Young Adults

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 29 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-08-01

Completion Date

2027-12-01

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

DEVICE

TearCare®

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.

Locations (1)

University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility

Birmingham, Alabama, United States