Dry Eye Disease
Conditions
Keywords
Microblepharoexfoliation, Intense pulse light, Meibomian gland expression, Meibomian gland dysfunction
Brief summary
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
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.
Interventions
PROCEDUREMicroblepharoexfoliation
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.
PROCEDUREIntense pulse light
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%.
PROCEDUREMeibomian gland expression
Finally, the MGX was performed on both upper and lower eyelids of each eye with a Collins forceps (Medi Instrument Inc, New York, USA).
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
Sponsors
University of Seville
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. 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. 3. 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
1. Skin pathologies that prevent IPL treatment 2. All corneal disorders that affect diagnostic tests, such as: (2.1) active corneal infections; and (2.2) corneal dystrophies. 3. Active ocular allergy. 4. Pregnant or lactating women.. 5. Patients who did not understand or comprehend the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular surface disease index (OSDI) questionnaire. | Change from Baseline OSDI at 2 months. | Values from 0 (Better) to 100 (Worse) |
| 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) | Change from Baseline LLG at 2 months. | Values from 0 (Better) to 4 (Worse) |
| Ciliary hyperemia | Change from Baseline Ciliary Hyperemia at 2 months. | Values from 0 (Better) to 100 (Worse) |
| Conjunctival hyperemia | Change from Baseline Conjunctival Hyperemia at 2 months. | Values from 0 (Better) to 100 (Worse) |
| Meibomian glands Loss area (LAMG) | Change from Baseline LAMG at 2 months. | Values from 0 (Better) to 100 (Worse) |
| Meibomian gland secretions (MGS) | Change from Baseline MGS at 2 months. | Values from 0 (Worse) to 45 (Better) |
| Meibomian gland Dysfunction Grade (MGD Grade) | Change from Baseline MGD grade at 2 months. | Values from 0 (Better) to 4 (Worse) |
| Ocular surface staining (OSS). | Change from Baseline OSS at 2 months. | Values from 0 (Better) to 4 (Worse) |
Countries
Spain
Outcome results
None listed