An interventional study of IPL and Heated eye mask in Dry Eye, sponsored by He Eye Hospital. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by He Eye Hospital · Not applicable, Interventional, and Treatment
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.
"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.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's planned enrollment of 116 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →He Eye Hospital is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
participants will receive IPL treatment with 12 homogeneously spaced pulses of light to both eyes at day 0, day 14, and day 28
Device: IPL
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
Device: Heated eye mask
VTPS group, Patients will receive a single 12-minute treatment using the LipiFlow® (TearScience Inc., Morrisville, NC) on both eyes at day 0
Device: LipiFlow®
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.
Device: EyePeace®
IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter
Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms
LipiFlow® can control the variables of temperature, pressure, and MG expression technique
The silicone-made flexible hand-held gadget applies regulated, vertical pressure to the closed eyelids.
Non-invasive tear breakup time (NITBUT)
Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequential readings will be captured, and the median value will be included in the final analysis. The median value will be recorded
Time frame: • 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.
Tear Film Lipid Layer Score (TFLL)
Tear film lipid layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan). The results will be graded as follows: grade 1, somewhat gray color, uniform distribution; grade 2, somewhat gray color, nonuniform distribution; grade 3, a few colors, nonuniform distribution; grade 4, many colors, nonuniform distribution; grade 5, corneal surface partially exposed
Time frame: • 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.
Meibomian gland function and secretion quality
Five meibomian glands in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste-like consistency meibum)
Time frame: • 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.
Ocular Surface Disease Index (OSDI)
The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome
Time frame: • 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.
Fluorescein and lissamine conjunctival and cornea staining (CFS)
Fluorescein and lissamine staining of the ocular surface will be divided into three zones comprising nasal conjunctival, corneal, and temporal conjunctival areas. The staining score ranged from 0 to 3 for each zone, yielding a total score of 0-9 for the ocular surface
Time frame: • 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.
Tear meniscus height (TMH)
Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded
Time frame: • 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.
Conjunctival hyperemia (RS score)
Conjunctival hyperemia (RS score) will be assessed by Keratograph image (Oculus, Germany) of 1156\*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 (normal) to 4.0 (severe)
Time frame: • 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.
Thermal imaging: Ocular surface temperature (OST)
All measurements were taken in the same room with controlled temperature and humidity. Prior to ocular thermography or other tests, participants were acclimatized to the room for 20 minutes. Morgan and colleagues described the following criteria for recording OST: The patients were instructed to blink normally, close their eyes for 3 seconds, and the first image was captured soon after the eyelids opened. The temperature was taken in the central cornea, which was defined as a circular area 4 mm in diameter in the middle of the cornea
Time frame: • 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.
No study locations are listed for this record.
Plan to share: Yes — The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The Steering Committee will write and submit the report for publication at the end of the study
Start is estimated for Nov 2023; primary completion for Dec 2023, 1 month later.
Of 185 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 25. This study's planned 1 month is below that.
Counting every sponsor, half of 293 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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He Eye Hospital