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The goal of this clinical trial is to assess the efficacy and safety of microblepharoeexfoliation (MBE), intense pulse light (IPL) and meibomian gland expression (MGX) combination in patients with meibomian gland dysfunction (MGD).
The main question it aims to answer are:
Participants were assigned to receive either three sessions of MBE-IPL-MGX treatment and home-based therapy (treatment group) or home-based therapy alone (control group).
The investigators will compare both groups to see if MBE-IPL-MGX treatment is superior to home-based therapy.
MBE is a novel in-office treatment that works by exfoliating the eyelid margins to remove the accumulated biofilm debris, epithelial keratinization and capped meibomian glands, resulting in better meibum outflow . Different studies have shown that MBE improves DED symptoms [1,2], demodex blepharitis [1-4] and meibomian gland function [2,3,5] In addition, meta-analyses recommend combining IPL with meibomian gland expression (MGX) compared to IPL or MGX alone [6-8]. However, the investigators have not found any studies evaluating the benefits of MBE combined with IPL and MGX.
Consequently, the purpose of the current study is to evaluate whether MBE combined with IPL and MGX leads to an improvement of symptoms and signs in patients with DED due to MGD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBE-IPL-MGX treatment and home-based therapy. | Experimental | In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy. |
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| Home-based therapy | Active Comparator | In this arm, participants received home-based therapy alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microblepharoexfoliation | Procedure | MBE was performed using the yokefellow instrument (Youke Electronic Corporation, Guangzhou, China), which contains a handpiece with a 1.80 mm diameter medical-grade diamond bur. Patients underwent MBE on the upper and lower lid margin of both eyes at 500 rpm until complete removal of accumulated biofilm debris, epithelial keratinization or capped meibomian glands. MBE was carried out only in the first combined treatment session. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular surface disease index (OSDI) questionnaire. | Values from 0 (Better) to 100 (Worse) | Change from Baseline OSDI at 2 months. |
| Tear meniscus height (TMH) | Change from Baseline TMH at 2 months. | |
| Tear meniscus area (TMA) | Change from Baseline TMA at 2 months. | |
| Noninvasive tear film break-up time (NIBUT). | Change from Baseline NIBUT at 2 months. | |
| Lipid Layer Grade (LLG) | Values from 0 (Better) to 4 (Worse) | Change from Baseline LLG at 2 months. |
| Ciliary hyperemia | Values from 0 (Better) to 100 (Worse) | Change from Baseline Ciliary Hyperemia at 2 months. |
| Conjunctival hyperemia | Values from 0 (Better) to 100 (Worse) | Change from Baseline Conjunctival Hyperemia at 2 months. |
| Meibomian glands Loss area (LAMG) | Values from 0 (Better) to 100 (Worse) | Change from Baseline LAMG at 2 months. |
| Meibomian gland secretions (MGS) | Values from 0 (Worse) to 45 (Better) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Ballesteros Sánchez | University of Seville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novovision ophthalmologic clinic | Murcia | 30009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29074306 | Background | Murphy O, O'Dwyer V, Lloyd-McKernan A. The efficacy of tea tree face wash, 1, 2-Octanediol and microblepharoexfoliation in treating Demodex folliculorum blepharitis. Cont Lens Anterior Eye. 2018 Feb;41(1):77-82. doi: 10.1016/j.clae.2017.10.012. Epub 2017 Oct 23. | |
| 35439775 | Background | Mohammad-Rabei H, Arabi A, Shahraki T, Rezaee-Alam Z, Baradaran-Rafii A. Role of Blepharoexfoliation in Demodex Blepharitis: A Randomized Comparative Study. Cornea. 2023 Jan 1;42(1):44-51. doi: 10.1097/ICO.0000000000003046. Epub 2022 Apr 13. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2023 | May 9, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 9, 2023 | May 9, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| Intense pulse light | Procedure | IPL treatment was carried out with Thermaeye Plus (MDS Medical Technologies SL, Barcelona, Spain). The procedure began by applying an ultrasound gel (Carmado SL, Alicante, Spain) to the patient's periocular areas and upper eyelids. In the periocular areas, 6 light pulses were applied; 4 light pulses on the skin below the lower eyelid (with handpiece placed horizontally in the first pass and vertically in the second pass) and 2 light pulses on the canthal area (with handpiece placed vertically in first and second pass). The parameters were as follows: (1) Filter: 650 nm; (2) fluence: 9 j/cm2; (3) pulses: 2; (4) duration: 3 ms; (5) Delay: 20 ms; and (6) Cooling: 70%. In the upper eyelids, 4 light pulses were applied; 2 light pulses in the first and second pass, respectively. The parameters were as follows: (1) Filter: 650 nm; (2) Fluence: 5 j/cm2; (3) pulses: 1; (4) duration: 3 ms and (5) Cooling: 70%. |
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| Meibomian gland expression | Procedure | Finally, the MGX was performed on both upper and lower eyelids of each eye with a Collins forceps (Medi Instrument Inc, New York, USA). |
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| Home-based therapy | Drug | Home-based therapy was based on Therapearl eye mask warming compress (Bausch & Lomb, Madrid, Spain) twice a day and Eyestil synfo eyedrops (Sifi Iberica SL, Madrid, Spain) 4 times a day during the study |
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| Change from Baseline MGS at 2 months. |
| Meibomian gland Dysfunction Grade (MGD Grade) | Values from 0 (Better) to 4 (Worse) | Change from Baseline MGD grade at 2 months. |
| Ocular surface staining (OSS). | Values from 0 (Better) to 4 (Worse) | Change from Baseline OSS at 2 months. |
| 31939919 | Background | Epstein IJ, Rosenberg E, Stuber R, Choi MB, Donnenfeld ED, Perry HD. Double-Masked and Unmasked Prospective Study of Terpinen-4-ol Lid Scrubs With Microblepharoexfoliation for the Treatment of Demodex Blepharitis. Cornea. 2020 Apr;39(4):408-416. doi: 10.1097/ICO.0000000000002243. |
| 30801507 | Background | Siddireddy JS, Tan J, Vijay AK, Willcox MDP. The Effect of Microblepharon Exfoliation on Clinical Correlates of Contact Lens Discomfort. Optom Vis Sci. 2019 Mar;96(3):187-199. doi: 10.1097/OPX.0000000000001354. |
| 31941589 | Background | Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Intense pulsed light therapy with meibomian gland expression for dry eye disease. Can J Ophthalmol. 2020 Jun;55(3):189-198. doi: 10.1016/j.jcjo.2019.11.009. Epub 2020 Jan 13. |
| 32725403 | Background | Leng X, Shi M, Liu X, Cui J, Sun H, Lu X. Intense pulsed light for meibomian gland dysfunction: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2021 Jan;259(1):1-10. doi: 10.1007/s00417-020-04834-1. Epub 2020 Jul 28. |
| 36044829 | Background | Miao S, Yan R, Jia Y, Pan Z. Effect of Intense Pulsed Light Therapy in Dry Eye Disease Caused by Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis. Eye Contact Lens. 2022 Oct 1;48(10):424-429. doi: 10.1097/ICL.0000000000000934. Epub 2022 Sep 5. |