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

May 9, 2023 updated by: Antonio Ballesteros Sánchez, University of Seville

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30009
        • Novovision ophthalmologic clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular surface disease index (OSDI) questionnaire.
Time Frame: Change from Baseline OSDI at 2 months.
Values from 0 (Better) to 100 (Worse)
Change from Baseline OSDI at 2 months.
Tear meniscus height (TMH)
Time Frame: Change from Baseline TMH at 2 months.
Change from Baseline TMH at 2 months.
Tear meniscus area (TMA)
Time Frame: Change from Baseline TMA at 2 months.
Change from Baseline TMA at 2 months.
Noninvasive tear film break-up time (NIBUT).
Time Frame: Change from Baseline NIBUT at 2 months.
Change from Baseline NIBUT at 2 months.
Lipid Layer Grade (LLG)
Time Frame: Change from Baseline LLG at 2 months.
Values from 0 (Better) to 4 (Worse)
Change from Baseline LLG at 2 months.
Ciliary hyperemia
Time Frame: Change from Baseline Ciliary Hyperemia at 2 months.
Values from 0 (Better) to 100 (Worse)
Change from Baseline Ciliary Hyperemia at 2 months.
Conjunctival hyperemia
Time Frame: Change from Baseline Conjunctival Hyperemia at 2 months.
Values from 0 (Better) to 100 (Worse)
Change from Baseline Conjunctival Hyperemia at 2 months.
Meibomian glands Loss area (LAMG)
Time Frame: Change from Baseline LAMG at 2 months.
Values from 0 (Better) to 100 (Worse)
Change from Baseline LAMG at 2 months.
Meibomian gland secretions (MGS)
Time Frame: Change from Baseline MGS at 2 months.
Values from 0 (Worse) to 45 (Better)
Change from Baseline MGS at 2 months.
Meibomian gland Dysfunction Grade (MGD Grade)
Time Frame: Change from Baseline MGD grade at 2 months.
Values from 0 (Better) to 4 (Worse)
Change from Baseline MGD grade at 2 months.
Ocular surface staining (OSS).
Time Frame: Change from Baseline OSS at 2 months.
Values from 0 (Better) to 4 (Worse)
Change from Baseline OSS at 2 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Investigators

  • Principal Investigator: Antonio Ballesteros Sánchez, University of Seville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

April 8, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIVIUS-ABS-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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