NCT06158997

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: He Eye Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Evaporative Dry Eye

Interventions

Type	Name	Description
DEVICE	EyePeace	EyePeace a commercially available for enhancing meibum expression. The flexible, handheld device is made of silicone and provides regulated vertical pressure on closed eyelids (https://www.eyepeace.de). EyePeace will be used to assess its usefulness in improving evaporative dry eye signs and symptoms.
DEVICE	Heated Eye Mask	Heated Eye Mask will be used once a day to assess its usefulness in improving evaporative dry eye signs and symptoms.

Timeline

• Start date: 2023-12-03
• Primary completion: 2024-02-01
• Completion: 2024-04-01
• First posted: 2023-12-06
• Last updated: 2023-12-06

Locations

1 site across 1 country: China