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

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Procedure: Microblepharoexfoliation; Procedure: Intense pulse light; Procedure: Meibomian gland expression; Drug: Home-based therapy

• Registration Number: NCT05857579
• Lead Sponsor: University of Seville

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.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-11-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-04-08
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBE-IPL-MGX treatment and home-based therapy.	Home-based therapy	In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
MBE-IPL-MGX treatment and home-based therapy.	Intense pulse light	In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
MBE-IPL-MGX treatment and home-based therapy.	Meibomian gland expression	In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
Home-based therapy	Home-based therapy	In this arm, participants received home-based therapy alone.
MBE-IPL-MGX treatment and home-based therapy.	Microblepharoexfoliation	In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.

Primary Outcome Measures

Name	Time	Method
Tear meniscus height (TMH)	Change from Baseline TMH at 2 months.
Meibomian gland secretions (MGS)	Change from Baseline MGS at 2 months.	Values from 0 (Worse) to 45 (Better)
Conjunctival hyperemia	Change from Baseline Conjunctival Hyperemia at 2 months.	Values from 0 (Better) to 100 (Worse)
Ciliary hyperemia	Change from Baseline Ciliary Hyperemia at 2 months.	Values from 0 (Better) to 100 (Worse)
Ocular surface disease index (OSDI) questionnaire.	Change from Baseline OSDI at 2 months.	Values from 0 (Better) to 100 (Worse)
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.
Meibomian glands Loss area (LAMG)	Change from Baseline LAMG at 2 months.	Values from 0 (Better) to 100 (Worse)
Ocular surface staining (OSS).	Change from Baseline OSS at 2 months.	Values from 0 (Better) to 4 (Worse)
Meibomian gland Dysfunction Grade (MGD Grade)	Change from Baseline MGD grade at 2 months.	Values from 0 (Better) to 4 (Worse)
Lipid Layer Grade (LLG)	Change from Baseline LLG at 2 months.	Values from 0 (Better) to 4 (Worse)

Trial Locations

Locations (1)

Novovision ophthalmologic clinic; 🇪🇸 Murcia, Spain