Diamond Bur Microblepharoexfoliation, Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye

Study Overview
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Brief Summary
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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: Does MBE-IPL-MGX treatment improve dry eye symptoms? Does MBE-IPL-MGX treatment improve dry eye signs? 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.

Detailed Description
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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.

Official Title
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Diamond Bur Microblepharoexfoliation Combined With Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye: A Short-term Controlled Study

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Procedure: Microblepharoexfoliation
* Procedure: Intense pulse light
* Procedure: Meibomian gland expression
* Drug: Home-based therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old DED diagnosis according to DEWS II meeting one of the following conditions: (2.1) ocular surface disease index (OSDI) score ≥ 13; (2.2) NIBUT < 10 seconds; and (2.3) ocular surface staining with > 5 or 9 corneal or conjunctival stains, respectively. MGD diagnosis according to the international workshop on MGD meeting two of the following conditions: (3.1) irregularity of the eyelid margin or mucocutaneous junction; (3.2) vascularity of the eyelid margin; (3.3) plugged or capped Meibomian gland orifices; (3.4) Meibomian gland atrophy; or (3.5) decreased meibum quality and quantity Exclusion Criteria: Skin pathologies that prevent IPL treatment All corneal disorders that affect diagnostic tests, such as: (2.1) active corneal infections; and (2.2) corneal dystrophies. Active ocular allergy. Pregnant or lactating women.. Patients who did not understand or comprehend the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBE-IPL-MGX treatment and home-based therapy.<br>In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy. | Procedure: Microblepharoexfoliation<br>* 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.<br>* Other names: MBE;Procedure: Intense pulse light<br>* 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%.<br>* Other names: IPL;Procedure: Meibomian gland expression<br>* Finally, the MGX was performed on both upper and lower eyelids of each eye with a Collins forceps (Medi Instrument Inc, New York, USA).<br>* Other names: MGX;Drug: Home-based therapy<br>* 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<br>* Other names: HBT;|
| Active Comparator: Home-based therapy<br>In this arm, participants received home-based therapy alone. | Drug: Home-based therapy<br>* 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<br>* Other names: HBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microblepharoexfoliation, Intense pulse light, Meibomian gland expression, Meibomian gland dysfunction