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

Sponsor

University of Seville (Other)

Overall Status

Completed

CT.gov ID

NCT05857579

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Procedure: Microblepharoexfoliation Procedure: Intense pulse light Procedure: Meibomian gland expression Drug: Home-based therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Nov 1, 2022

Actual Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBE-IPL-MGX treatment and home-based therapy. In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.	Procedure: Microblepharoexfoliation 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 Procedure: Intense pulse light 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 Procedure: Meibomian gland expression 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 Drug: Home-based therapy 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
Active Comparator: Home-based therapy In this arm, participants received home-based therapy alone.	Drug: Home-based therapy 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

Arm

Intervention/Treatment

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

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

Procedure: Microblepharoexfoliation

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

Procedure: Intense pulse light

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

Procedure: Meibomian gland expression

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

Drug: Home-based therapy

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

Active Comparator: Home-based therapy

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

Drug: Home-based therapy

Other Names:

HBT

Outcome Measures

Primary Outcome Measures

Ocular surface disease index (OSDI) questionnaire. [Change from Baseline OSDI at 2 months.]
Values from 0 (Better) to 100 (Worse)
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) [Change from Baseline LLG at 2 months.]
Values from 0 (Better) to 4 (Worse)
Ciliary hyperemia [Change from Baseline Ciliary Hyperemia at 2 months.]
Values from 0 (Better) to 100 (Worse)
Conjunctival hyperemia [Change from Baseline Conjunctival Hyperemia at 2 months.]
Values from 0 (Better) to 100 (Worse)
Meibomian glands Loss area (LAMG) [Change from Baseline LAMG at 2 months.]
Values from 0 (Better) to 100 (Worse)
Meibomian gland secretions (MGS) [Change from Baseline MGS at 2 months.]
Values from 0 (Worse) to 45 (Better)
Meibomian gland Dysfunction Grade (MGD Grade) [Change from Baseline MGD grade at 2 months.]
Values from 0 (Better) to 4 (Worse)
Ocular surface staining (OSS). [Change from Baseline OSS at 2 months.]
Values from 0 (Better) to 4 (Worse)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.