Clinical Study Using Eye Lipid Mobilizer (ELM) With Heat and Vibration To Treat Evaporative Dry Eye Disease
- Conditions
- Evaporative Dry Eye DiseaseMeibomian Gland Dysfunction
- Interventions
- Device: ELM
- Registration Number
- NCT06242860
- Lead Sponsor
- Eyedetec Medical, Inc.
- Brief Summary
The goal of this clinical trial is to evaluate the Eye Lipid Mobilizer (ELM) for the treatment of evaporative dry eye disease associated with meibomian gland dysfunction. The main questions aim to confirm that 1) the ELM can meet its intended use by validated patient reporting outcomes and 2) to confirm that the ELM device can be used safely by different users within a clinical environment as determined by review of any adverse events related to the use of the device.
- Detailed Description
The purpose of the clinical study is to evaluate the Eye Lipid Mobilizer for the treatment of evaporative Dry Eye Disease associated with Meibomian Gland Dysfunction. The objective of the study is to confirm that the Eye Lipid Mobilizer (ELM) can meet its intended use by validated patient reporting outcomes.
The secondary objective is the ELM device can be used safety with no adverse events. The Eye Lipid Mobilizer (ELM) System is intended for the application of localized heat and vibration therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- At least 21 years old
- Confirmed evaporative dry eye disease
- Ocular surgery, trauma, herpes infections
- Unwillingness to comply with study protocol
- Pregnant or nursing women
- Any subject that cannot wear an eye mask
- Participation in another ophthalmic clinical trial within past 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single ELM Treatment ELM To undergo the ELM procedure, the subject will sit comfortably in an exam chair. The Headset and Eye Pads will be adjusted to fit comfortably over gently closed eyelids. The subject will rest their head back. The ELM will be turned on, and will be active for 15 minutes wherein patients will feel a warming sensation to their eyes and a gentle vibration. The ELM is then removed. Daily ELM Treatment ELM To undergo the ELM procedure, the subject will sit comfortably in an exam chair. The Headset and Eye Pads will be adjusted to fit comfortably over gently closed eyelids. The subject will rest their head back. The ELM will be turned on, and will be active for 15 minutes wherein patients will feel a warming sensation to their eyes and a gentle vibration. The ELM is then removed. Subject will take personalized ELM home and use it as directed on a daily basis
- Primary Outcome Measures
Name Time Method Procedure-related adverse events one week, four weeks Incidence of procedure-related adverse events will be assessed
Device-related adverse events one week, four weeks Incidence of device-related adverse events will be assessed
- Secondary Outcome Measures
Name Time Method Slip Lamp Evaluation one week, four weeks Change of appearance of cornea under slit lamp evaluation compared to baseline
Corneal Fluorescein Staining one week, four weeks Change in appearance of fluorescein staining compared to baseline
SPEED II Questionnaire for Dry Eye one week, four weeks Change in outcomes for SPEED II Questionnaire for Dry Eye compared to baseline
Lipid Layer Thickness one week, four weeks Change in thickness of lipid layer compared to baseline
Meibomian Gland Imaging one week, four weeks Change in meibomian gland under imaging compared to baseline
Tear Break Up Time one week, four weeks Change in tear break up time compared to baseline
Trial Locations
- Locations (1)
EYEcenter Optometric
🇺🇸Citrus Heights, California, United States