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

NCT05857579 | Completed

• 1 other identifier: CIVIUS-ABS-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Keywords

Microblepharoexfoliation; Intense pulse light; Meibomian gland expression; Meibomian gland dysfunction

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (2)

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.

Procedure: Microblepharoexfoliation; Procedure: Intense pulse light; Procedure: Meibomian gland expression; Drug: Home-based therapy

Home-based therapy

ACTIVE COMPARATOR

In this arm, participants received home-based therapy alone.

Drug: Home-based therapy

Interventions

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.

Also known as: MBE

MBE-IPL-MGX treatment and home-based therapy.

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%.

Also known as: IPL

MBE-IPL-MGX treatment and home-based therapy.

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).

Also known as: MGX

MBE-IPL-MGX treatment and home-based therapy.

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

Also known as: HBT

Home-based therapy; MBE-IPL-MGX treatment and home-based therapy.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Novovision ophthalmologic clinic

Murcia, 30009, Spain

Location

Related Publications (7)

• 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.

  PMID: 29074306 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.

  PMID: 35439775 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.

  PMID: 31939919 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.

  PMID: 30801507 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.

  PMID: 31941589 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.

  PMID: 32725403 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.

  PMID: 36044829 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Antonio Ballesteros Sánchez

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: May 12, 2023
• Study Start: April 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

ES (1)