Clinical trial NCT05923528: Comparison of Non-pharmaceutical Treatments for Evaporative Dry Eye
Official title: Comparison of Non-pharmaceutical Treatments for Evaporative Dry Eye: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Keywords: dry eye
intense pulsed light
heated eye mask
eyepeace
lipiflow
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-invasive tear breakup time (NITBUT)
timeFrame: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
Secondary outcomes:
measure: Tear Film Lipid Layer Score (TFLL)
timeFrame: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
measure: Meibomian gland function and secretion quality
timeFrame: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
measure: Ocular Surface Disease Index (OSDI)
timeFrame: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
measure: Fluorescein and lissamine conjunctival and cornea staining (CFS)
timeFrame: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
measure: Tear meniscus height (TMH)
timeFrame: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
measure: Conjunctival hyperemia (RS score)
timeFrame: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
measure: Thermal imaging: Ocular surface temperature (OST)
timeFrame: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
Other outcomes:
Locations:
Study officials:
affiliation: He eye specialist hospital
name: Emmanuel Eric Pazo
role: STUDY_CHAIR
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