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

University of Seville

Status: Completed

Conditions: Dry Eye Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05857579

CIVIUS-ABS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

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

Experimental group

Description:

In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.

Treatment:

Procedure: Intense pulse light

Procedure: Microblepharoexfoliation

Drug: Home-based therapy

Procedure: Meibomian gland expression

Home-based therapy

Active Comparator group

Description:

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

Treatment:

Drug: Home-based therapy