Back to resultsDiamond Bur Microblepharoexfoliation, Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Microblepharoexfoliation
Intense pulse light
Meibomian gland expression
Home-based therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease focused on measuring Microblepharoexfoliation, Intense pulse light, Meibomian gland expression, Meibomian gland dysfunction
Eligibility Criteria
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.
Sites / Locations
- Novovision ophthalmologic clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MBE-IPL-MGX treatment and home-based therapy.
Home-based therapy
Arm Description
In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
In this arm, participants received home-based therapy alone.
Outcomes
Primary Outcome Measures
Ocular surface disease index (OSDI) questionnaire.
Values from 0 (Better) to 100 (Worse)
Tear meniscus height (TMH)
Tear meniscus area (TMA)
Noninvasive tear film break-up time (NIBUT).
Lipid Layer Grade (LLG)
Values from 0 (Better) to 4 (Worse)
Ciliary hyperemia
Values from 0 (Better) to 100 (Worse)
Conjunctival hyperemia
Values from 0 (Better) to 100 (Worse)
Meibomian glands Loss area (LAMG)
Values from 0 (Better) to 100 (Worse)
Meibomian gland secretions (MGS)
Values from 0 (Worse) to 45 (Better)
Meibomian gland Dysfunction Grade (MGD Grade)
Values from 0 (Better) to 4 (Worse)
Ocular surface staining (OSS).
Values from 0 (Better) to 4 (Worse)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05857579
Brief Title
Diamond Bur Microblepharoexfoliation, Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye
Official Title
Diamond Bur Microblepharoexfoliation Combined With Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye: A Short-term Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
4. Oversight
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
Microblepharoexfoliation, Intense pulse light, Meibomian gland expression, Meibomian gland dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBE-IPL-MGX treatment and home-based therapy.
Arm Type
Experimental
Arm Description
In this arm, participants received three sessions of MBE-IPL-MGX treatment and home-based therapy.
Arm Title
Home-based therapy
Arm Type
Active Comparator
Arm Description
In this arm, participants received home-based therapy alone.
Intervention Type
Procedure
Intervention Name(s)
Microblepharoexfoliation
Other Intervention Name(s)
MBE
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intense pulse light
Other Intervention Name(s)
IPL
Intervention Description
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%.
Intervention Type
Procedure
Intervention Name(s)
Meibomian gland expression
Other Intervention Name(s)
MGX
Intervention Description
Finally, the MGX was performed on both upper and lower eyelids of each eye with a Collins forceps (Medi Instrument Inc, New York, USA).
Intervention Type
Drug
Intervention Name(s)
Home-based therapy
Other Intervention Name(s)
HBT
Intervention Description
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
Primary Outcome Measure Information:
Title
Ocular surface disease index (OSDI) questionnaire.
Description
Values from 0 (Better) to 100 (Worse)
Time Frame
Change from Baseline OSDI at 2 months.
Title
Tear meniscus height (TMH)
Time Frame
Change from Baseline TMH at 2 months.
Title
Tear meniscus area (TMA)
Time Frame
Change from Baseline TMA at 2 months.
Title
Noninvasive tear film break-up time (NIBUT).
Time Frame
Change from Baseline NIBUT at 2 months.
Title
Lipid Layer Grade (LLG)
Description
Values from 0 (Better) to 4 (Worse)
Time Frame
Change from Baseline LLG at 2 months.
Title
Ciliary hyperemia
Description
Values from 0 (Better) to 100 (Worse)
Time Frame
Change from Baseline Ciliary Hyperemia at 2 months.
Title
Conjunctival hyperemia
Description
Values from 0 (Better) to 100 (Worse)
Time Frame
Change from Baseline Conjunctival Hyperemia at 2 months.
Title
Meibomian glands Loss area (LAMG)
Description
Values from 0 (Better) to 100 (Worse)
Time Frame
Change from Baseline LAMG at 2 months.
Title
Meibomian gland secretions (MGS)
Description
Values from 0 (Worse) to 45 (Better)
Time Frame
Change from Baseline MGS at 2 months.
Title
Meibomian gland Dysfunction Grade (MGD Grade)
Description
Values from 0 (Better) to 4 (Worse)
Time Frame
Change from Baseline MGD grade at 2 months.
Title
Ocular surface staining (OSS).
Description
Values from 0 (Better) to 4 (Worse)
Time Frame
Change from Baseline OSS at 2 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Ballesteros Sánchez
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novovision ophthalmologic clinic
City
Murcia
ZIP/Postal Code
30009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29074306
Citation
Murphy O, O'Dwyer V, Lloyd-McKernan A. The efficacy of tea tree face wash, 1, 2-Octanediol and microblepharoexfoliation in treating Demodex folliculorum blepharitis. Cont Lens Anterior Eye. 2018 Feb;41(1):77-82. doi: 10.1016/j.clae.2017.10.012. Epub 2017 Oct 23.
Results Reference
background
PubMed Identifier
35439775
Citation
Mohammad-Rabei H, Arabi A, Shahraki T, Rezaee-Alam Z, Baradaran-Rafii A. Role of Blepharoexfoliation in Demodex Blepharitis: A Randomized Comparative Study. Cornea. 2023 Jan 1;42(1):44-51. doi: 10.1097/ICO.0000000000003046. Epub 2022 Apr 13.
Results Reference
background
PubMed Identifier
31939919
Citation
Epstein IJ, Rosenberg E, Stuber R, Choi MB, Donnenfeld ED, Perry HD. Double-Masked and Unmasked Prospective Study of Terpinen-4-ol Lid Scrubs With Microblepharoexfoliation for the Treatment of Demodex Blepharitis. Cornea. 2020 Apr;39(4):408-416. doi: 10.1097/ICO.0000000000002243.
Results Reference
background
PubMed Identifier
30801507
Citation
Siddireddy JS, Tan J, Vijay AK, Willcox MDP. The Effect of Microblepharon Exfoliation on Clinical Correlates of Contact Lens Discomfort. Optom Vis Sci. 2019 Mar;96(3):187-199. doi: 10.1097/OPX.0000000000001354.
Results Reference
background
PubMed Identifier
31941589
Citation
Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Intense pulsed light therapy with meibomian gland expression for dry eye disease. Can J Ophthalmol. 2020 Jun;55(3):189-198. doi: 10.1016/j.jcjo.2019.11.009. Epub 2020 Jan 13.
Results Reference
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PubMed Identifier
32725403
Citation
Leng X, Shi M, Liu X, Cui J, Sun H, Lu X. Intense pulsed light for meibomian gland dysfunction: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2021 Jan;259(1):1-10. doi: 10.1007/s00417-020-04834-1. Epub 2020 Jul 28.
Results Reference
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PubMed Identifier
36044829
Citation
Miao S, Yan R, Jia Y, Pan Z. Effect of Intense Pulsed Light Therapy in Dry Eye Disease Caused by Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis. Eye Contact Lens. 2022 Oct 1;48(10):424-429. doi: 10.1097/ICL.0000000000000934. Epub 2022 Sep 5.
Results Reference
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Diamond Bur Microblepharoexfoliation, Intense Pulse Light and Meibomian Gland Expression for Evaporative Dry Eye
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