Safety and Effectiveness of EyePeace on Signs and Symptoms of Dry Eye Disease

He Eye Hospital

Status: Not yet enrolling

Conditions: Evaporative Dry Eye

Treatments: Device: Heated Eye Mask; Device: EyePeace

Study type: Interventional

Funder types: Other

Identifiers

NCT06158997

DEDEP2023

Details and patient eligibility

About

In this study, the EyePeace an eye massager will be compared with a standard-of-care warm compress treatment with evaporative dry eye disease. The objective is to asses the safety and effectiveness EyePeace eye massager is in relieving the signs and symptoms of evaporative dry eye disease.

Full description

A prospective, contralateral-eye trial study compared the effects of Eyepeace+Heated eye mask versus Heated eye mask with dry eye patients. Following 10 min of heated eye mask on both eyes, eyelid massage therapy was applied to the right eye by device. The efficiency was evaluated at baseline (0 mins), 5 minutes (5 mins), 15 minutes (15 mins), and 30 minutes (30 mins) by having the patient perform the eyelid expression massage under the supervision of an ophthalmologist. Non-invasive breakup time (NITBUT), tear meniscus height (TMH), tear-film lipid layer (TFLL), ocular surface temperature (OST), meibomian gland quality (MGQ), meibomian gland expressibility (MGEx), best corrected visual acuity (BCVA), intraocular pressure (IOP), endothelial cell count (ECC), flat-axis keratometry value (K1), steep-axis keratometry value (K2), and central corneal thickness (CCT) were examined.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Able and willing to comply with the treatment/follow-up schedule
• Bilateral signs and symptoms of dry eye disease or MGD

Exclusion criteria

• Treat dry eye with medication or massage or fumigation within 1 month
• The eyelids or intraocular tumor unfavorable pressure
• Previous ocular surgery or trauma
• Barriers to the subjects in the research of ocular surface active allergies, infection or inflammatory bowel disease
• Intraocular pressure is less than 10 mmHg or more than 21 mmHg
• Diabetes or other eye table, healthy body, skin diseases, or diseases of the nervous system;
• Use any may interfere with tears within three months of systemic anti-inflammatory drugs or medicines, such as resistance to anxiety, depression and antihistamines
• The local administration of ophthalmology recent history (in the past 30 days) including antibiotics, steroids and non-steroidal anti-inflammatory drug, or long-term use of local ophthalmic drug
• Researchers determine patients not suitable for this study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

EyePeace+Heated eye mask group

Experimental group

Description:

Participants will received the HEM therapy for 10 minutes according to the manufacturer's instructions. This was followed immediately by 10 gentle squeezes of the eyelid massage device on one eye

Treatment:

Device: EyePeace

Device: Heated Eye Mask

Heated Eye Mask group

Active Comparator group

Description:

Participants in Heated Eye Mask group will use heated eye mask once.

Treatment:

Device: Heated Eye Mask