Clinical trial NCT05857579: Diamond Bur Microblepharoexfoliation, Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye
Official title: Diamond Bur Microblepharoexfoliation Combined With Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye: A Short-term Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Keywords: Microblepharoexfoliation
Intense pulse light
Meibomian gland expression
Meibomian gland dysfunction
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ocular surface disease index (OSDI) questionnaire.
timeFrame: Change from Baseline OSDI at 2 months.
measure: Tear meniscus height (TMH)
timeFrame: Change from Baseline TMH at 2 months.
measure: Tear meniscus area (TMA)
timeFrame: Change from Baseline TMA at 2 months.
measure: Noninvasive tear film break-up time (NIBUT).
timeFrame: Change from Baseline NIBUT at 2 months.
measure: Lipid Layer Grade (LLG)
timeFrame: Change from Baseline LLG at 2 months.
measure: Ciliary hyperemia
timeFrame: Change from Baseline Ciliary Hyperemia at 2 months.
measure: Conjunctival hyperemia
timeFrame: Change from Baseline Conjunctival Hyperemia at 2 months.
measure: Meibomian glands Loss area (LAMG)
timeFrame: Change from Baseline LAMG at 2 months.
measure: Meibomian gland secretions (MGS)
timeFrame: Change from Baseline MGS at 2 months.
measure: Meibomian gland Dysfunction Grade (MGD Grade)
timeFrame: Change from Baseline MGD grade at 2 months.
measure: Ocular surface staining (OSS).
timeFrame: Change from Baseline OSS at 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Novovision ophthalmologic clinic
Study officials:
affiliation: University of Seville
name: Antonio Ballesteros Sánchez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.