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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: IPL group | Experimental | participants will receive IPL treatment with 12 homogeneously spaced pulses of light to both eyes at day 0, day 14, and day 28 |
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| Group B: HEM group | Experimental | 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 |
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| Group C: VTPS group | Experimental | VTPS group, Patients will receive a single 12-minute treatment using the LipiFlow® (TearScience Inc., Morrisville, NC) on both eyes at day 0 |
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| Group D: EyePeace® group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPL | Device | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | • 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 | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel Eric Pazo | Contact | +8618612782131 | ericpazo@outlook.com | |
| Jiayan Chen | Contact | +8618304019060 | chenjiayan@hsyk.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Eric Pazo | He Eye Specialist Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32836200 | Background | Ma J, Pazo EE, Zou Z, Jin F. Prevalence of symptomatic dry eye in breast cancer patients undergoing systemic adjuvant treatment: A cross-sectional study. Breast. 2020 Oct;53:164-171. doi: 10.1016/j.breast.2020.07.009. Epub 2020 Aug 5. | |
| 28736335 | Background | Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20. |
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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.
The Steering Committee will write and submit the report for publication at the end of the study
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Heated eye mask | Device | Heated eye mask will be used to assess its usefulness in dry eye signs and symptoms |
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| LipiFlow® | Device | LipiFlow® can control the variables of temperature, pressure, and MG expression technique |
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| EyePeace® | Device | The silicone-made flexible hand-held gadget applies regulated, vertical pressure to the closed eyelids. |
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| • 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) | • 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 | • 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 | • 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 | • 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) | • 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 | • 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. |
| 32925801 | Background | Zhang X, Wang L, Zheng Y, Deng L, Huang X. Prevalence of dry eye disease in the elderly: A protocol of systematic review and meta-analysis. Medicine (Baltimore). 2020 Sep 11;99(37):e22234. doi: 10.1097/MD.0000000000022234. |
| 32756182 | Background | Wu MF, Gao H, Zhao LJ, Chen H, Huang YK. Real dynamic assessment of tear film optical quality for monitoring and early prevention of dry eye. Medicine (Baltimore). 2020 Jul 31;99(31):e21494. doi: 10.1097/MD.0000000000021494. |
| 31374018 | Background | Fu J, Chou Y, Hao R, Jiang X, Liu Y, Li X. Evaluation of ocular surface impairment in meibomian gland dysfunction of varying severity using a comprehensive grading scale. Medicine (Baltimore). 2019 Aug;98(31):e16547. doi: 10.1097/MD.0000000000016547. |
| 31514344 | Background | Heidari M, Noorizadeh F, Wu K, Inomata T, Mashaghi A. Dry Eye Disease: Emerging Approaches to Disease Analysis and Therapy. J Clin Med. 2019 Sep 11;8(9):1439. doi: 10.3390/jcm8091439. |
| 34433517 | Background | Song Y, Yu S, He X, Yang L, Wu Y, Qin G, Zhang Q, Deep Singh Talwar G, Xu L, Moore JE, He W, Pazo EE. Tear film interferometry assessment after intense pulsed light in dry eye disease: A randomized, single masked, sham-controlled study. Cont Lens Anterior Eye. 2022 Aug;45(4):101499. doi: 10.1016/j.clae.2021.101499. Epub 2021 Aug 22. |
| 32685729 | Background | Ikonne EU, Ikpeazu VO, Ugbogu EA. The potential health benefits of dietary natural plant products in age related eye diseases. Heliyon. 2020 Jul 10;6(7):e04408. doi: 10.1016/j.heliyon.2020.e04408. eCollection 2020 Jul. |
| 17077654 | Background | Matsumoto Y, Dogru M, Goto E, Ishida R, Kojima T, Onguchi T, Yagi Y, Shimazaki J, Tsubota K. Efficacy of a new warm moist air device on tear functions of patients with simple meibomian gland dysfunction. Cornea. 2006 Jul;25(6):644-50. doi: 10.1097/01.ico.0000208822.70732.25. |
| 35298282 | Background | Xu L, Wu Y, Song Y, Zhang Q, Qin G, Yang L, Ma J, Palme C, Moore JE, Pazo EE, He W. Comparison Between Heated Eye Mask and Intense Pulsed Light Treatment for Contact Lens-Related Dry Eye. Photobiomodul Photomed Laser Surg. 2022 Mar;40(3):189-197. doi: 10.1089/photob.2021.0094. |
| 34741758 | Background | Wu Y, Xu L, Song Y, Zhang Q, Qin G, Yang L, Ma J, Palme C, Moore JE, Pazo EE, He W. Management of Post-LASIK Dry Eye with Intense Pulsed Light in Combination with 0.1% Sodium Hyaluronate and Heated Eye Mask. Ophthalmol Ther. 2022 Feb;11(1):161-176. doi: 10.1007/s40123-021-00418-2. Epub 2021 Nov 6. |
| 12695712 | Background | Olson MC, Korb DR, Greiner JV. Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Eye Contact Lens. 2003 Apr;29(2):96-9. doi: 10.1097/01.ICL.0000060998.20142.8D. |
| 31358441 | Background | Wang MTM, Feng J, Wong J, Turnbull PR, Craig JP. Randomised trial of the clinical utility of an eyelid massage device for the management of meibomian gland dysfunction. Cont Lens Anterior Eye. 2019 Dec;42(6):620-624. doi: 10.1016/j.clae.2019.07.008. Epub 2019 Jul 26. |
| 38413161 | Derived | Chen J, Qin G, Yu S, Moore J, Xu L, He W, Pazo EE, He X. Comparison of non-pharmaceutical treatments for evaporative dry eye: a randomised controlled study protocol. BMJ Open. 2024 Feb 26;14(2):e078727. doi: 10.1136/bmjopen-2023-078727. |