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Completed

NCT Number: NCT05857579

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

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novovision ophthalmologic clinic

Murcia, 30009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MBE

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%.

Other names: IPL

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).

Other names: MGX

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

Other names: HBT

Primary outcomes

  1. Ocular surface disease index (OSDI) questionnaire.

    Time frame: Change from Baseline OSDI at 2 months.

    Values from 0 (Better) to 100 (Worse)

  2. Tear meniscus height (TMH)

    Time frame: Change from Baseline TMH at 2 months.

  3. Tear meniscus area (TMA)

    Time frame: Change from Baseline TMA at 2 months.

  4. Noninvasive tear film break-up time (NIBUT).

    Time frame: Change from Baseline NIBUT at 2 months.

  5. Lipid Layer Grade (LLG)

    Time frame: Change from Baseline LLG at 2 months.

    Values from 0 (Better) to 4 (Worse)

  6. Ciliary hyperemia

    Time frame: Change from Baseline Ciliary Hyperemia at 2 months.

    Values from 0 (Better) to 100 (Worse)

  7. Conjunctival hyperemia

    Time frame: Change from Baseline Conjunctival Hyperemia at 2 months.

    Values from 0 (Better) to 100 (Worse)

  8. Meibomian glands Loss area (LAMG)

    Time frame: Change from Baseline LAMG at 2 months.

    Values from 0 (Better) to 100 (Worse)

  9. Meibomian gland secretions (MGS)

    Time frame: Change from Baseline MGS at 2 months.

    Values from 0 (Worse) to 45 (Better)

  10. Meibomian gland Dysfunction Grade (MGD Grade)

    Time frame: Change from Baseline MGD grade at 2 months.

    Values from 0 (Better) to 4 (Worse)

  11. Ocular surface staining (OSS).

    Time frame: Change from Baseline OSS at 2 months.

    Values from 0 (Better) to 4 (Worse)

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 12, 2023
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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