Comparison of Non-pharmaceutical Treatments for Evaporative Dry Eye

He Eye Hospital

Status: Not yet enrolling

Conditions: Dry Eye

Treatments: Device: Heated eye mask; Device: EyePeace®; Device: IPL; Device: LipiFlow®

Study type: Interventional

Funder types: Other

Identifiers

NCT05923528

TREATDE2023

Details and patient eligibility

About

The lipid layer of the tear film is critical to maintaining the integrity of the tear film and deficiency in the tear film lipid layer (TFLL) is the cause of evaporative dry eye (EDE) in approximately 80% of dry eye disease patients, resulting in excessive evaporation (so-called hyperevaporative dry eye). This study protocol was designed to assess and compare the effects of intense pulsed light (IPL), heated eye mask (HEM), vectored thermal pulsation system (VTPS), and eyelid massage device (EMD) for improving signs and symptoms of EDE.

EDE patients will be randomly divided into IPL, HEM, VTPS, and EMD groups and will be followed up for four weeks. The primary outcome measure will be non-invasive tear breakup time (NITBUT). The secondary outcome measures will include, tear film lipid layer score (TFLL), meibomian gland function and secretion quality change from baseline conjunctival and cornea staining (CFS) with fluorescein and lissamine, tear meniscus height (TMH), conjunctival hyperemia (RS score) and ocular surface disease index (OSDI) questionnaire. Additionally, adverse events also were monitored and documented.

Full description

"A chronic, diffuse abnormality of the meibomian glands, frequently characterized by terminal duct obstruction and/or qualitative/quantitative abnormalities in glandular secretion," is how the International Workshop on meibomian gland (MG) hypofunction or dysfunction (MGD) describes MGD. These glands, which are repurposed sebaceous glands, secrete meibum onto the ocular surface. By improving the quality and quantity of meibum secretion, signs and symptoms of evaporative dry eye (EDE) and MGD can be alleviated.

Traditional remedies derived from natural sources have been utilized for treating anterior eye ailments since ancient times, predating the advent of contemporary pharmacological interventions. These remedies continue to be employed in diverse populations globally. The objective of this study is to examine the present non-pharmacological modalities that have been implemented and evaluate their efficacy. This encompasses alternative medicine, extant non-pharmaceutical therapeutic modalities, as well as contemporary low and high technological interventions. The most common approaches to relieving MGD involve the application of heat to the eyelids with and without physical massage of the eyelids in order to express the MGs.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 90 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 (a) the ocular surface disease index (OSDI) questionnaire ≥ 13, (b) a non-invasive tear film breakup time (NITBUT) of ≤10 s, or a conjunctivocorneal staining score (CS) of ≥ 3 points. The presence of two or more criteria was used to establish a positive DE diagnosis, based on the 2016 Asia Dry Eye Society criteria
• Lipid layer thickness score evaluation ≥ 2.

Exclusion criteria

• existing ocular trauma, infectious diseases, recent surgical history
• skin defects, pigmentation, moles, scars in the treatment area, skin cancer
• autoimmune diseases, skin allergies
• pregnancy or lactation
• photophobia that may cause reflex tearing or difficulty in evaluating the patient's lipid layer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 4 patient groups

Group A: IPL group

Experimental group

Description:

participants will receive IPL treatment with 12 homogeneously spaced pulses of light to both eyes at day 0, day 14, and day 28

Treatment:

Device: IPL

Group B: HEM group

Experimental group

Description:

participants were applied an air-activated disposable eye mask on both closed eyes (Ocuface Medical Co., Ltd., Guangzhou, China) simultaneously for 15 minutes according to the manufacturer's instructions every day for 42 days

Treatment:

Device: Heated eye mask

Group C: VTPS group

Experimental group

Description:

VTPS group, Patients will receive a single 12-minute treatment using the LipiFlow® (TearScience Inc., Morrisville, NC) on both eyes at day 0

Treatment:

Device: LipiFlow®

Group D: EyePeace® group

Experimental group

Description:

Participants were followed immediately by 10 gentle squeezes of the eyelid massage device (EMD) on both eyes, and 10 gentle eyelid massaging movements using the index and middle fingers every day for 42 days.

Treatment:

Device: EyePeace®